Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06397300
Status:
COMPLETED
Last Update Posted:
2024-05-02
First Post:
2024-04-18
Brief Title:
Comparison of US Bilateral Erector Spinae Plane Block US Bilateral Quadratus Lumborum Block and Lumbar Epidural for Postoperative Analgesia in Patients Undergoing Total Abdominal Hysterectomy
Sponsor:
National Cancer Institute Egypt
Organization:
National Cancer Institute Egypt
Study Overview
Official Title:
Comparison of Ultrasound Guided Bilateral Erector Spinae Plane Block Ultrasound Guided Bilateral Quadratus Lumborum Block and Lumbar Epidural for Postoperative Analgesia in Patients Undergoing Total Abdominal Hysterectomy a Prospective Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigators hypothesize that US Bilateral Erector Spinae Plane Block US Bilateral Quadratus Lumborum Block and Lumbar Epidural for Postoperative Analgesia in Patients Undergoing Total Abdominal Hysterectomy resulting in reducing myofascial pain and opioid consumption
Detailed Description:
Background and Rationale
Gynecological cancers comprise 10-15 of womens cancers mainly affecting women post-reproductive age but posing threats to fertility for younger patients
The goal of postoperative pain control is to reduce the negative consequences associated with acute postsurgical pain and help the patient make a smooth transition back to normal function Traditionally opioid analgesic therapy has served as the mainstay of treatment for acute postoperative pain However the recent rise in morbidity and mortality associated with opioid misuse has led to increasing demands for more investigative efforts into developing pain treatment strategies that place more emphasis on using a multimodal approach These efforts have proved to be challenging as the subjective nature of pain perception further complicates the ability to achieve satisfactory pain control Furthermore specific patient comorbidities and social factors may predispose patients to have increased pain perception
Approximately 75 percent of patients who undergo surgery experience acute postoperative pain which is often medium-high in severity Less than half of patients undergoing surgery report adequate postoperative pain relief This percentage presents a significant problem as inadequate postoperative pain control may lead to adverse physiologic effects among patients in the immediate postoperative period and place them at increased risk of developing chronic pain associated with the procedure Severe persistent postoperative pain affects 2 to 10 percent of adults
Multiple peer-reviewed publications address the topic of postoperative pain control in gynecologic oncology surgery Because many of these surgeries require large laparotomy incisions patients frequently receive intravenous opioids for pain control Patient-controlled analgesia or PCAs are often used as the mechanism of delivery as they allow patients to deliver pain medications based on their perceived needs Intravenous opioids are associated with undesired side effects including nausea pruritus hallucinations and delay in the return of bowel function which may ultimately lead to prolonged hospitalization and extended recovery times The use of ultrasonographic technology in regional anesthesia practice has not only eased the application of nerve blocks and interfascial blocks but also led to the definition and practical use of many new interfascial blocks Thoracoabdominalthoracolumbar blocks - also named as truncal blocks have gained popularity recently with the number of such defined blocks increasing substantially
Erector spinae plane block ESPB is an interfacial plane block that provides truncal analgesia Originally described in 2016 as an analgesic technique for thoracic neuropathic pain ESPB has since been applied in abdominal procedures While the mechanism of ESBP requires further investigation some postulate the target to be the ventral rami of spinal nerves Recent randomized trials have showed ESPB to reduce pain scores in cardiac and breast surgeries
Since Blanco et al first described the Quadratratus lumborum block QLB in 2007 its use in abdominal surgeries has been shown to be superior to the transversus abdominis plane TAP block for postoperative analgesia in this group of patients Dam et al defined the transmuscular approach QL-TM for this block
Regarding major lower abdominal surgery epidural analgesia was shown to be the gold standard time-tested technique for providing postoperative analgesia but due to its possible complications contraindications there is a need for other equally efficient analgesic techniques
Study Design
This is a prospective randomized clinical trial The patients will be randomly assigned into three equal comparable groups each of them contains 30 patients using computer-generated random numbers
Each patient signed an informed consent form for block interventions and participation in the study Patients age between 18 and 65 years with American Society of anesthesiology ASA physical status II-III-IV who will be scheduled for an elective open total abdominal hysterectomy will be included in the study Ultrasound guided nerve blocks and epidural injection will be applied after induction of general anesthesia
The first group will receive bilateral Ultrasound guided erector spinae plane ESP block which is a relatively new block technique and many case reports show the efficacy of this technique for different uses To perform ESP block in the lateral position bilaterally the skin will be disinfected with 70 alcohol bilaterally and a linear transducer is placed in a longitudinal parasagittal orientation and erector spinae muscle trapezius muscle rhomboid major muscle rhomboid major muscle is absent below T6 level and transverse process are visualized and local anesthetic is injected 025 bupivacaine 20 ml in each side in the area between transverse process and erector spinae muscle at T10 level 19 Hadi Ufuk Yrükoğlu et al have been using this technique in their clinic for many different indications and the results are promising
The second group of patients will receive quadratus lumborum block which will be done in the lateral decubitus position Right block will be performed the patient will then repositioned for the left block An ultrasound device will be used in which a convex probe with broadband 5-8 MHz will be placed in the mid-axillary line just above the iliac crest to identify the three muscles of the anterior abdominal wall transversus abdominis internal oblique and external oblique Then scan dorsally to keep the transverse orientation until seeing the aponeurosis of the transverses abdominus muscle and by following this aponeurosis QL muscle will be visualized with its attachment to the lateral edge of the transverse process of the L2 vertebral body and visualize the thoracolumbar fascia at the lateral edge of the QL muscle The view of the psoas major muscle anteriorly the erector spinae muscle posteriorly and the QL muscle adherent to the apex of the transverse process result in a well-known view of a Shamrock with three leaves trifoliate A spinal needle 20G will be inserted in-plane from the anterior to posterior direction and the tip of the needle will be advanced anterior to the QL muscle The target site for injection is the plane between the quadratus lumborum and psoas major muscles A test dose of 1 mL of saline will be injected for hydro visualization of the needle tip position and for confirming its correct positioning This will be followed by injection of 025 bupivacaine 20 ml in each side The dose should not exceed the safe limits 2 mgkg of bupivacaine Bupivacaine will be applied on each side between the quadratus lumborum muscle and the psoas major muscle in the interfascial plane using the in-plane technique
The third group of patients will receive lumbar epidural under strict aseptic precautions lumbar epidural was performed for patients in Group III using a 16-gauge Touhy epidural needle by a median approach The T12 - L1 or L1 - L2 interspaces was chosen for the injection
The epidural space identified by the loss of resistance technique The catheter was advanced 4 cm cephalad When the aspiration test results for blood and cerebrospinal fluid were negative a test dose of 3 mL 2 lidocaine with 1 200000 adrenaline was given after the placement of the epidural catheter
Then this will be followed by injection of 025 bupivacaine 15 ml as a single injection after induction of general anesthesia
Study Methods
Population of the study
Patients scheduled for elective open total abdominal hysterectomy at the National Cancer Institute who meet the inclusion criteria
Background and demographic characteristics
90 patients ASA II-III-IV scheduled for elective open total abdominal hysterectomy under general anaesthesia
Methodology
Patients between 18-65 years old who scheduled for total abdominal hysterectomy will be enrolled in the study Approval of the ethical committee and informed written consent from all patients will be issued Patients will be given a full and detailed explanation of the intended study protocol and will be informed about the potential benefits of the development of a successful technique as well as the potential side-effects
Study protocol Patients will be assessed the day before surgery in a preoperative visit for evaluating their medical status laboratory investigations and for fulfilling all the above inclusion and exclusion criteria
The patients will be instructed how to report pain by means of the visual analogue scale VAS score rating in which 0 no pain and 10 worst possible pain22 All groups of the study will be premedicated with IV 002 mgkg midazolam 30 minutes preoperatively Heart rate HR mean arterial blood pressure MBP oxygen saturation SO2 will be monitored before induction of anaesthesia base line values immediately before surgical incision and at 30 min intervals intraoperative
Anesthesia Management
Induction of general anaesthesia in all study groups will be performed using a regimen of IV 1 μcgkg fentanyl and IV 2 mg kg propofol Tracheal intubation will be facilitated using 05 mgkg IV of Atracurium Anesthesia will be maintained with inhaled isoflurane with MAC 12-14 in oxygen enriched air FiO 205 and top up doses of atracurium 01 mgkg IV will be administered as required All patients will be mechanically ventilated aiming to keep end tidal carbon dioxide within the range of 30-35 mmHg Additional bolus doses of fentanyl 05µgkg will be given if the mean arterial blood pressure or heart rate rises above 20 of baseline values The total intraoperative fentanyl consumption will be recorded in all study groups
Ringer acetate will be infused in order to replace any fluid deficit maintenance and losses
Hypotension will be defined as MAP less than 60mmHg or less than 30 from baseline Severe ie MBP less than 60 mmHg or prolonged ie duration greater than or equal to 2 min episodes of hypotension will be treated with 09 normal saline andor 5mg ephedrine in incremental doses in order to maintain mean blood pressure above 70 mmHg At the end of surgery the residual neuromuscular blockade will be reversed using neostigmine 005 mgkg and atropine 002 mgkg and extubation will be performed after complete recovery of the airway reflexes The patients will be transferred to the post anaesthesia care unit where MAP heart rate and VAS pain score will be noted immediately on arrival and at 4 8 12 and 24 h postoperatively Rescue analgesia will be provided in the form of IV morphine 3 mg boluses if the pain score was 3 The total amount of morphine given in 24 h will be recorded in the three groups Thereafter the patients will be shifted to ward and will be given acetaminophen 1 g IV every 8 hours
Gynecological cancers comprise 10-15 of womens cancers mainly affecting women post-reproductive age but posing threats to fertility for younger patients
The goal of postoperative pain control is to reduce the negative consequences associated with acute postsurgical pain and help the patient make a smooth transition back to normal function Traditionally opioid analgesic therapy has served as the mainstay of treatment for acute postoperative pain However the recent rise in morbidity and mortality associated with opioid misuse has led to increasing demands for more investigative efforts into developing pain treatment strategies that place more emphasis on using a multimodal approach These efforts have proved to be challenging as the subjective nature of pain perception further complicates the ability to achieve satisfactory pain control Furthermore specific patient comorbidities and social factors may predispose patients to have increased pain perception
Approximately 75 percent of patients who undergo surgery experience acute postoperative pain which is often medium-high in severity Less than half of patients undergoing surgery report adequate postoperative pain relief This percentage presents a significant problem as inadequate postoperative pain control may lead to adverse physiologic effects among patients in the immediate postoperative period and place them at increased risk of developing chronic pain associated with the procedure Severe persistent postoperative pain affects 2 to 10 percent of adults
Multiple peer-reviewed publications address the topic of postoperative pain control in gynecologic oncology surgery Because many of these surgeries require large laparotomy incisions patients frequently receive intravenous opioids for pain control Patient-controlled analgesia or PCAs are often used as the mechanism of delivery as they allow patients to deliver pain medications based on their perceived needs Intravenous opioids are associated with undesired side effects including nausea pruritus hallucinations and delay in the return of bowel function which may ultimately lead to prolonged hospitalization and extended recovery times The use of ultrasonographic technology in regional anesthesia practice has not only eased the application of nerve blocks and interfascial blocks but also led to the definition and practical use of many new interfascial blocks Thoracoabdominalthoracolumbar blocks - also named as truncal blocks have gained popularity recently with the number of such defined blocks increasing substantially
Erector spinae plane block ESPB is an interfacial plane block that provides truncal analgesia Originally described in 2016 as an analgesic technique for thoracic neuropathic pain ESPB has since been applied in abdominal procedures While the mechanism of ESBP requires further investigation some postulate the target to be the ventral rami of spinal nerves Recent randomized trials have showed ESPB to reduce pain scores in cardiac and breast surgeries
Since Blanco et al first described the Quadratratus lumborum block QLB in 2007 its use in abdominal surgeries has been shown to be superior to the transversus abdominis plane TAP block for postoperative analgesia in this group of patients Dam et al defined the transmuscular approach QL-TM for this block
Regarding major lower abdominal surgery epidural analgesia was shown to be the gold standard time-tested technique for providing postoperative analgesia but due to its possible complications contraindications there is a need for other equally efficient analgesic techniques
Study Design
This is a prospective randomized clinical trial The patients will be randomly assigned into three equal comparable groups each of them contains 30 patients using computer-generated random numbers
Each patient signed an informed consent form for block interventions and participation in the study Patients age between 18 and 65 years with American Society of anesthesiology ASA physical status II-III-IV who will be scheduled for an elective open total abdominal hysterectomy will be included in the study Ultrasound guided nerve blocks and epidural injection will be applied after induction of general anesthesia
The first group will receive bilateral Ultrasound guided erector spinae plane ESP block which is a relatively new block technique and many case reports show the efficacy of this technique for different uses To perform ESP block in the lateral position bilaterally the skin will be disinfected with 70 alcohol bilaterally and a linear transducer is placed in a longitudinal parasagittal orientation and erector spinae muscle trapezius muscle rhomboid major muscle rhomboid major muscle is absent below T6 level and transverse process are visualized and local anesthetic is injected 025 bupivacaine 20 ml in each side in the area between transverse process and erector spinae muscle at T10 level 19 Hadi Ufuk Yrükoğlu et al have been using this technique in their clinic for many different indications and the results are promising
The second group of patients will receive quadratus lumborum block which will be done in the lateral decubitus position Right block will be performed the patient will then repositioned for the left block An ultrasound device will be used in which a convex probe with broadband 5-8 MHz will be placed in the mid-axillary line just above the iliac crest to identify the three muscles of the anterior abdominal wall transversus abdominis internal oblique and external oblique Then scan dorsally to keep the transverse orientation until seeing the aponeurosis of the transverses abdominus muscle and by following this aponeurosis QL muscle will be visualized with its attachment to the lateral edge of the transverse process of the L2 vertebral body and visualize the thoracolumbar fascia at the lateral edge of the QL muscle The view of the psoas major muscle anteriorly the erector spinae muscle posteriorly and the QL muscle adherent to the apex of the transverse process result in a well-known view of a Shamrock with three leaves trifoliate A spinal needle 20G will be inserted in-plane from the anterior to posterior direction and the tip of the needle will be advanced anterior to the QL muscle The target site for injection is the plane between the quadratus lumborum and psoas major muscles A test dose of 1 mL of saline will be injected for hydro visualization of the needle tip position and for confirming its correct positioning This will be followed by injection of 025 bupivacaine 20 ml in each side The dose should not exceed the safe limits 2 mgkg of bupivacaine Bupivacaine will be applied on each side between the quadratus lumborum muscle and the psoas major muscle in the interfascial plane using the in-plane technique
The third group of patients will receive lumbar epidural under strict aseptic precautions lumbar epidural was performed for patients in Group III using a 16-gauge Touhy epidural needle by a median approach The T12 - L1 or L1 - L2 interspaces was chosen for the injection
The epidural space identified by the loss of resistance technique The catheter was advanced 4 cm cephalad When the aspiration test results for blood and cerebrospinal fluid were negative a test dose of 3 mL 2 lidocaine with 1 200000 adrenaline was given after the placement of the epidural catheter
Then this will be followed by injection of 025 bupivacaine 15 ml as a single injection after induction of general anesthesia
Study Methods
Population of the study
Patients scheduled for elective open total abdominal hysterectomy at the National Cancer Institute who meet the inclusion criteria
Background and demographic characteristics
90 patients ASA II-III-IV scheduled for elective open total abdominal hysterectomy under general anaesthesia
Methodology
Patients between 18-65 years old who scheduled for total abdominal hysterectomy will be enrolled in the study Approval of the ethical committee and informed written consent from all patients will be issued Patients will be given a full and detailed explanation of the intended study protocol and will be informed about the potential benefits of the development of a successful technique as well as the potential side-effects
Study protocol Patients will be assessed the day before surgery in a preoperative visit for evaluating their medical status laboratory investigations and for fulfilling all the above inclusion and exclusion criteria
The patients will be instructed how to report pain by means of the visual analogue scale VAS score rating in which 0 no pain and 10 worst possible pain22 All groups of the study will be premedicated with IV 002 mgkg midazolam 30 minutes preoperatively Heart rate HR mean arterial blood pressure MBP oxygen saturation SO2 will be monitored before induction of anaesthesia base line values immediately before surgical incision and at 30 min intervals intraoperative
Anesthesia Management
Induction of general anaesthesia in all study groups will be performed using a regimen of IV 1 μcgkg fentanyl and IV 2 mg kg propofol Tracheal intubation will be facilitated using 05 mgkg IV of Atracurium Anesthesia will be maintained with inhaled isoflurane with MAC 12-14 in oxygen enriched air FiO 205 and top up doses of atracurium 01 mgkg IV will be administered as required All patients will be mechanically ventilated aiming to keep end tidal carbon dioxide within the range of 30-35 mmHg Additional bolus doses of fentanyl 05µgkg will be given if the mean arterial blood pressure or heart rate rises above 20 of baseline values The total intraoperative fentanyl consumption will be recorded in all study groups
Ringer acetate will be infused in order to replace any fluid deficit maintenance and losses
Hypotension will be defined as MAP less than 60mmHg or less than 30 from baseline Severe ie MBP less than 60 mmHg or prolonged ie duration greater than or equal to 2 min episodes of hypotension will be treated with 09 normal saline andor 5mg ephedrine in incremental doses in order to maintain mean blood pressure above 70 mmHg At the end of surgery the residual neuromuscular blockade will be reversed using neostigmine 005 mgkg and atropine 002 mgkg and extubation will be performed after complete recovery of the airway reflexes The patients will be transferred to the post anaesthesia care unit where MAP heart rate and VAS pain score will be noted immediately on arrival and at 4 8 12 and 24 h postoperatively Rescue analgesia will be provided in the form of IV morphine 3 mg boluses if the pain score was 3 The total amount of morphine given in 24 h will be recorded in the three groups Thereafter the patients will be shifted to ward and will be given acetaminophen 1 g IV every 8 hours
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IRB00004025 | OTHER | National Cancer Institute Cairo university | None |