Ignite Creation Date:
2024-05-06 @ 7:11 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05925972
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-13
First Post:
2023-06-06
Brief Title:
Analgesic Efficacy of Plan Blocks in Laparoscopic Hysterectomies
Sponsor:
Balikesir University
Organization:
Balikesir University
Study Overview
Official Title:
Effects of Ultrasonography-Guided Plan Blocks ESPOSTAP on Perioperative Analgesia in Laparoscopic Hysterectomies
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
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:
Hysterectomy is the most common major intervention in gynecology after cesarean section Indications include myoma uteri abnormal uterine bleeding cervical intraepithelial neoplasia chronic pelvic pain uterine uteri operated breast cancer and endometrial hyperplasia Today hysterectomy can be performed abdominally vaginally and laparoscopically¹ Laparoscopic hysterectomy LH has several advantages and disadvantages compared to other forms of hysterectomy Shorter recovery time less wound infection shorter hospital stay and less need for postoperative analgesia can be counted among the advantages The prolongation of the operation time and the increased risk of urinary complications are disadvantages² Postoperative pain management can be done with different methods depending on the location of the surgical field the type of surgical procedure the patients need for analgesia and patient preference These methods include oral intravenous or intramuscular medication and nerve blocks In order to minimize the side effects of opioids used in analgesic therapy such as respiratory depression nausea-vomiting lethargy constipation and itching and to increase the analgesic effect the balanced analgesia method is used⁴ With this method opioids non-opioid analgesics or peripheral nerve-field blocks side effects are minimized and optimum analgesia is provided
Transversus abdominis plane TAP block which is one of the abdominal field blocks was first described by Rafi in 2001⁶ Hebbard et al stated in 2007 that ultrasonography USG-guided TAP block can be applied more effectively and safely⁷ This block can be applied more effectively and safely⁷ This block is antero-lateral posterior and oblique It can be done subcostal with three different approaches TAP block has been shown to reduce postoperative pain after hysterectomy cesarean section and colorectal surgery⁸ Erector spina plane ESP block was first described by Forero et al in 2016 on a patient with chronic neuropathic pain⁹ The basic technique is performed paraspinally under USG guidance It is used for postoperative analgesia in breast thoracic surgeries hernia repair dorsal colon abdomen and hip surgery
In this study it is aimed to compare the effects of USG-guided ESP block and OSTAP block applications on perioperative pain control in total laparoscopic hysterectomy operations
Transversus abdominis plane TAP block which is one of the abdominal field blocks was first described by Rafi in 2001⁶ Hebbard et al stated in 2007 that ultrasonography USG-guided TAP block can be applied more effectively and safely⁷ This block can be applied more effectively and safely⁷ This block is antero-lateral posterior and oblique It can be done subcostal with three different approaches TAP block has been shown to reduce postoperative pain after hysterectomy cesarean section and colorectal surgery⁸ Erector spina plane ESP block was first described by Forero et al in 2016 on a patient with chronic neuropathic pain⁹ The basic technique is performed paraspinally under USG guidance It is used for postoperative analgesia in breast thoracic surgeries hernia repair dorsal colon abdomen and hip surgery
In this study it is aimed to compare the effects of USG-guided ESP block and OSTAP block applications on perioperative pain control in total laparoscopic hysterectomy operations
Detailed Description:
MATERIAL AND METHOD Patients between the ages of 18-65 ASA I-II BMI 30 kgm2 who will undergo elective surgery under general anesthesia with voluntary consent will be included in the study Patients with local anesthetic allergy coagulopathy infection at the block application site and mental deficiency and for whom the surgical plan has been changed complicatedopen surgery will be excluded from the study
Patients included in the study will be informed about patient-controlled analgesia PCA and numerical rating scale NRS Numeric Rating Scale for the assessment of pain severity before the operation Demographic data of the patients will be recorded
Anesthesia Application
After the intravenous IV route is provided with a 20 G cannula in the preoperative preparation room 10 mLkg of balanced crystalloid fluid infusion will be started 003 mgkg midazolam will be administered for premedication Standard monitoring ECG heart rate non-invasive blood pressure SPO2 temperature and neuromuscular monitoring will be applied to all patients The input value of these parameters will be saved before induction Records will be taken at 5-minute intervals until the end of the operation For induction of anesthesia 2 mgkg propofol 1μgkg remifentanil will be administered as an IV bolus within 60 seconds Analgesia maintenance will be provided with 005-025 μgkgmin remifentanil infusion Muscle relaxation will be provided with IV 06 mgkg rocuronium He will be intubated orotracheally when his train of four rate TOFR response is zero In case of neuromuscular blocker requirement IV 001 mgkg rocuronium will be additionally administered Anesthesia is maintained with 05 Lmin fresh gas flow oxygen concentration with inspiratory oxygen level between 40-45 minimum alveolar concentration MAC with 09-11 with sevoflurane will be applied Mechanical ventilation will be performed with Volume AutoFlow mod V-AF with ETCO2 between 35-40 mmHg
Patients will be randomly divided into two groups after induction Group ESP I The group to which Erector Spina Plan Block ESP will be administered Group OSTAP II The group to which Oblique Subcostal Transversus Abdominis Plan Block OSTAP will be applied In the study anesthesia induction and plan blocks will be performed by the same anesthesiologist Intraoperative and postoperative data recording and patient evaluation will be done by two separate anesthesiologists
ESP Block Application
In the lateral decubitus position after induction in accordance with the rules of asepsis-antisepsis USG Sonosite M-Turbo machine linear 6-13 mHz probe will be placed approximately 3 cm lateral to the T9 spinous process in the sagittal plane and with an in-plane approach the hyperechoic shadow of the transverse process and the erector spina muscle Once the ESM has been identified a 22 G 80 mm Stimuplex Ultra 360 BBraun Melsungen Germany needle will be inserted in the cephalocaudal direction to gently contact the T9 spinous process over the erector spinae After negative pressure aspiration between the transverse process and ECM 1-2 mL of local anesthetic will be injected and after cephalocaudal spread is observed a total of 20 mL of 025 mgmL bupivacaine will be given by intermittent aspiration every 4-5 mL The same procedure will be applied to the other side
OSTAP Block Application
After the induction in the supine position in accordance with the rules of asepsis-antisepsis the USG Sonosite M-Turbo machine will be placed on the anterior axillary line the linear 6-13 mHz probe will be placed on the subcostal lower edge between the xiphoid and the anterosuperior iliac process and the rectus abdominis and transversus abdominis muscles will be visualized Then 22 G 80 mm StimuplexUltra 360 BBraun Melsungen Germany needle is directed in-plane from 2-3 cm medial of the rectus abdominis muscle negative pressure aspiration between the transversus abdominis and rectus abdominis muscles is applied 1-2 mL of local anesthetic will be injected After local anesthetic spread is observed a total of 20 mL of 025 mgmL bupivacaine will be given by intermittent aspiration every 4-5 mL The same procedure will be applied to the other side
Surgical incision will be made 15 minutes after block applications Patients will undergo standard surgical procedures The patients will be operated in the 45⁰ trendelenburg position and the pneumoperitoneum pressure is 10-12 mmHg In case of 15 change in the hemodynamic parameters of the patient compared to the initial values the remifentanil infusion dose will be increased or decreased at the specified intervals and the amount consumed intraoperatively at the end of the operation will be recorded It will be defined as hypotension when the systolic arterial pressure decreases by 30 from the baseline value In the treatment 250 mL of 09 NaCl will be rapidly infused first If there is no response 10 mg of ephedrine will be given IV When bradycardia occurs heart rate 50 beatsmin IV 05 mg of atropine will be administered The time from the skin incision to the end of the surgical procedure will be recorded as Operation Time
Sevoflurane flow and remifentanil infusion will be terminated 15 minutes before the end of the operation Patients will be administered 50 mg dexketoprofen trometamol IV and 1 g paracetamol IV infusion At the end of the operation the fresh gas flow will be increased to 8 Lmin To end the neuromuscular blockade 4 mgkg of sugammadex will be administered IV When the TOFR is 09 he will be extubated and transferred to the postoperative recovery unit PACU The time between termination of sevoflurane flow and extubation will be recorded as Extubation time and the time between anesthesia induction and extubation will be recorded as Anesthesia Time
Patient-controlled analgesia PCA and morphine infusion will be administered to both groups of patients in the PACU
Morphine protocol It will be prepared as 1 mgmL with 5 mL Morphine Sulphate 50mg 45 mL physiological saline It will be administered as an intermittent bolus of 1 mg without basal infusion with a 20-minute lock-in time
Postoperative pain intensity sedation level and nausea-vomiting score of the patients at rest and movement status will be evaluated at 0 2 4 6 12 and 24 hours by an anesthesiologist who is not familiar with the study groups
The severity of pain will be evaluated with NRS at rest and in motion 0 No pain 1 2 3 4 5 6 7 8 9 10 Unbearable pain If NRS4 dexketoprofen trometamol 50 mg IV will be administered as a rescue analgesic
The Observers Assessment of the AlertnessSedation OAAS will be used to monitor the sedation level of the patient
Nausea will be measured with 4 categorical scoring systems No nausea 0 Mild 1 Moderate 2 Severe 3 For the treatment of nausea-vomiting 4mg ondansetron will be administered IV Patients with a modified Aldrete score 9 will be discharged to the ward The time elapsed between the patients admission to the PACU and discharge to the service will be recorded as Recovery Time
Patients included in the study will be informed about patient-controlled analgesia PCA and numerical rating scale NRS Numeric Rating Scale for the assessment of pain severity before the operation Demographic data of the patients will be recorded
Anesthesia Application
After the intravenous IV route is provided with a 20 G cannula in the preoperative preparation room 10 mLkg of balanced crystalloid fluid infusion will be started 003 mgkg midazolam will be administered for premedication Standard monitoring ECG heart rate non-invasive blood pressure SPO2 temperature and neuromuscular monitoring will be applied to all patients The input value of these parameters will be saved before induction Records will be taken at 5-minute intervals until the end of the operation For induction of anesthesia 2 mgkg propofol 1μgkg remifentanil will be administered as an IV bolus within 60 seconds Analgesia maintenance will be provided with 005-025 μgkgmin remifentanil infusion Muscle relaxation will be provided with IV 06 mgkg rocuronium He will be intubated orotracheally when his train of four rate TOFR response is zero In case of neuromuscular blocker requirement IV 001 mgkg rocuronium will be additionally administered Anesthesia is maintained with 05 Lmin fresh gas flow oxygen concentration with inspiratory oxygen level between 40-45 minimum alveolar concentration MAC with 09-11 with sevoflurane will be applied Mechanical ventilation will be performed with Volume AutoFlow mod V-AF with ETCO2 between 35-40 mmHg
Patients will be randomly divided into two groups after induction Group ESP I The group to which Erector Spina Plan Block ESP will be administered Group OSTAP II The group to which Oblique Subcostal Transversus Abdominis Plan Block OSTAP will be applied In the study anesthesia induction and plan blocks will be performed by the same anesthesiologist Intraoperative and postoperative data recording and patient evaluation will be done by two separate anesthesiologists
ESP Block Application
In the lateral decubitus position after induction in accordance with the rules of asepsis-antisepsis USG Sonosite M-Turbo machine linear 6-13 mHz probe will be placed approximately 3 cm lateral to the T9 spinous process in the sagittal plane and with an in-plane approach the hyperechoic shadow of the transverse process and the erector spina muscle Once the ESM has been identified a 22 G 80 mm Stimuplex Ultra 360 BBraun Melsungen Germany needle will be inserted in the cephalocaudal direction to gently contact the T9 spinous process over the erector spinae After negative pressure aspiration between the transverse process and ECM 1-2 mL of local anesthetic will be injected and after cephalocaudal spread is observed a total of 20 mL of 025 mgmL bupivacaine will be given by intermittent aspiration every 4-5 mL The same procedure will be applied to the other side
OSTAP Block Application
After the induction in the supine position in accordance with the rules of asepsis-antisepsis the USG Sonosite M-Turbo machine will be placed on the anterior axillary line the linear 6-13 mHz probe will be placed on the subcostal lower edge between the xiphoid and the anterosuperior iliac process and the rectus abdominis and transversus abdominis muscles will be visualized Then 22 G 80 mm StimuplexUltra 360 BBraun Melsungen Germany needle is directed in-plane from 2-3 cm medial of the rectus abdominis muscle negative pressure aspiration between the transversus abdominis and rectus abdominis muscles is applied 1-2 mL of local anesthetic will be injected After local anesthetic spread is observed a total of 20 mL of 025 mgmL bupivacaine will be given by intermittent aspiration every 4-5 mL The same procedure will be applied to the other side
Surgical incision will be made 15 minutes after block applications Patients will undergo standard surgical procedures The patients will be operated in the 45⁰ trendelenburg position and the pneumoperitoneum pressure is 10-12 mmHg In case of 15 change in the hemodynamic parameters of the patient compared to the initial values the remifentanil infusion dose will be increased or decreased at the specified intervals and the amount consumed intraoperatively at the end of the operation will be recorded It will be defined as hypotension when the systolic arterial pressure decreases by 30 from the baseline value In the treatment 250 mL of 09 NaCl will be rapidly infused first If there is no response 10 mg of ephedrine will be given IV When bradycardia occurs heart rate 50 beatsmin IV 05 mg of atropine will be administered The time from the skin incision to the end of the surgical procedure will be recorded as Operation Time
Sevoflurane flow and remifentanil infusion will be terminated 15 minutes before the end of the operation Patients will be administered 50 mg dexketoprofen trometamol IV and 1 g paracetamol IV infusion At the end of the operation the fresh gas flow will be increased to 8 Lmin To end the neuromuscular blockade 4 mgkg of sugammadex will be administered IV When the TOFR is 09 he will be extubated and transferred to the postoperative recovery unit PACU The time between termination of sevoflurane flow and extubation will be recorded as Extubation time and the time between anesthesia induction and extubation will be recorded as Anesthesia Time
Patient-controlled analgesia PCA and morphine infusion will be administered to both groups of patients in the PACU
Morphine protocol It will be prepared as 1 mgmL with 5 mL Morphine Sulphate 50mg 45 mL physiological saline It will be administered as an intermittent bolus of 1 mg without basal infusion with a 20-minute lock-in time
Postoperative pain intensity sedation level and nausea-vomiting score of the patients at rest and movement status will be evaluated at 0 2 4 6 12 and 24 hours by an anesthesiologist who is not familiar with the study groups
The severity of pain will be evaluated with NRS at rest and in motion 0 No pain 1 2 3 4 5 6 7 8 9 10 Unbearable pain If NRS4 dexketoprofen trometamol 50 mg IV will be administered as a rescue analgesic
The Observers Assessment of the AlertnessSedation OAAS will be used to monitor the sedation level of the patient
Nausea will be measured with 4 categorical scoring systems No nausea 0 Mild 1 Moderate 2 Severe 3 For the treatment of nausea-vomiting 4mg ondansetron will be administered IV Patients with a modified Aldrete score 9 will be discharged to the ward The time elapsed between the patients admission to the PACU and discharge to the service will be recorded as Recovery Time
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