Ignite Creation Date:
2024-07-17 @ 11:17 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06488183
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-28
Brief Title:
Laparoscopic Preperitoneal Local Anesthetic Infiltration Versus Ultrasound Guided Quadratus Lumborum Block in Laparoscopic Bariatric Surgery
Sponsor:
sarah mohamed
Organization:
Alexandria University
Study Overview
Official Title:
Laparoscopic Preperitoneal Local Anesthetic Infiltration Versus Ultrasound Guided Quadratus Lumborum Block in Laparoscopic Bariatric Surgery
Status:
RECRUITING
Status Verified Date:
2024-06
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:
preperitoneal local anesthetic infiltration is effective for relief of postoperative pain in patients undergoing laparoscopic bariatric surgery
Detailed Description:
Obesity and overweight have become a global epidemic impacting people of all ages and socioeconomic status Obesity is still a major public health issue globally despite progress in some places Bariatric surgery remains the most effective and long-lasting way to lose weight and address obesity-related conditions1 Optimizing postoperative pain treatment is crucial for reducing complications shortening hospital stays and lowering expenditures in patients undergoing surgery Multimodal analgesia and postoperative pain reduction are especially relevant to bariatric surgery patients who frequently have numerous coexisting conditions and are more vulnerable to thrombotic and respiratory problems Obstructive sleep apnea OSA is common among obese individuals making safe analgesic treatment problematic Controlling pain following bariatric surgery is particularly difficult General management recommendations include multimodal analgesic therapy regional methods avoidance of sedatives and early mobilization2 3 4 5
Blanco originally described the quadratus lumborum block QLB in 2007 The primary benefit of QLB is the extension of a local anesthetic agent beyond the transversus abdominis plane into the thoracic paravertebral area The greater distribution of local anesthetic agents may provide significant analgesia and prolong the action of the injected local anesthetic solution6
Preperitoneal local anesthetic injection was initially developed by Dean et al as a pain management strategy for laparoscopic hernia repair and it is currently widely used7 A recent meta-analysis compared preperitoneal and subcutaneous wound catheters to epidural analgesia Preperitoneal wound catheters were shown to be as effective as epidural analgesia in abdominal surgeries Periportal wound catheters appear to be more effective in terms of patient satisfaction and recovery8 A recent study concluded that preperitoneal local anesthetic infiltration is effective for relief of postoperative pain in patients undergoing laparoscopic bariatric surgery9
Aim of the work
The present study aims to compare the analgesic efficacy of ultrasound-guided trans-muscular quadratus lumborum block QLB to preperitoneal local anesthetic infiltration during laparoscopic bariatric surgery and in the early postoperative period
Primary outcome
Postoperative pain score
Secondary outcomes
Intraoperative fentanyl requirements
Postoperative morphine requirements
Time to first dose of rescue analgesia
Postoperative nausea and vomiting
Length of stay in PACU
Early mobilization
Length of hospital stay
Patients
Study settings
This study will be conducted in general surgery department Alexandria university hospitals
Study design
Double blind randomized prospective and controlled study
Sample size calculation
Based on previous study10 11 we would need a minimum sample size of 44 participants 22 in each group to reliably detect an effect size of δ 0883 assuming a two-sided criterion for detection that allows for a maximum type I error rate of a 005 that achieve 80 power
Table 1 - Sample Size and Power Analysis User Defined Group P LPLAI Group Q QLB Effect Size Power α 22 22 0883 0800 00500
The power analysis of sample size 22 in this study equals 080 this indicates there is an 80 probability that the statistical test used in our study will correctly reject the null hypothesis
Study population
All patients will be randomized 11 using a sealed envelope method Patients will be divided into two equal groups
Group Q patients will undergo laparoscopic bariatric surgery under general anesthesia and bilateral ultrasound guided quadratus lamborum block QLB
Group P patients will undergo laparoscopic bariatric surgery under general anesthesia and preincisional laparoscopic preperitoneal bupivacaine infiltration
Inclusion criteria
1 Age 20-50 years both sexes
2 ASA physical status class I to III
3 BMI 35-50 kgm²
Exclusion criteria
1 Severe cardiac disorder
2 chronic renal failure
3 liver cirrhosis
4 allergy to bupivacaine
5 patients with history of chronic opioid consumption
6 HBA1C 7
Methods
Preoperative evaluation and preparation
During preoperative visit evaluation of patients will be carried out through proper history taking clinical examination and routine laboratory investigations including complete blood picture coagulation profile blood urea serum creatinine serum electrolytes fasting blood glucose glycosylated haemoglobin HBA1C liver function tests and any other investigation needed
Pre-anesthetic preparation and premedication
Informed written consent from all individual participants who will be included in this study will be taken during preoperative visit
Patients should be trained during preoperative visit on a visual analogue scale VAS with 0 corresponding to no pain and 10 to the worst pain imaginable
Patients will be informed about the analgesic regimen
Thrombotic prophylaxis enoxaparin 40 mg will be started 12 hours before surgery
On arrival to operative theatre intravenous cannula will be inserted and standard monitoring will be established using multichannel monitor Carescape Monitor B650 GE Healthcare Finland to monitor the following in both groups
Electrocardiogram ECG for heart rate and rhythm Beatsmin
Non-invasive measurement of arterial blood pressure Mean blood pressure in mmHg
Pulse oxygen saturation SpO2
End tidal CO2 tension in mmHg
Entropy
Anesthesia
After preoxygenation for 3 minutes anesthesia will be induced in both groups with propofol 2mgkg of lean body weight until loss of verbal response fentanyl 2µgkg and atracurium 05 mgkg intravenously Anesthesia will be maintained by isoflurane with 50 oxygen in air 12-15 to maintain entropy between 40-60 Mechanical ventilation will be performed with tidal volume of 8 ml kg and a respiratory rate of 12-15 cyclesmin to maintain the end-tidal carbon dioxide tension between 35 and 40 mmHg and an oxygen saturation of 98 per cent with 50 percent oxygen in air Incremental doses of atracurium will be given every 30 minutes to maintain muscle relaxation In both groups signs of insufficient analgesia eg tachycardia over 20 of the preoperative value occur during anesthesia or somatic response eg movement tearing or sweating will be treated with additional boluses of fentanyl 05 mcgkg intraoperatively as needed Intraoperatively all patients will receive IV dexamethasone 8 mg paracetamol 1 g ketorolac 30 mg
All patients in group Q will receive bilateral injection of 30ml bupivicaine 025 between quadratus lumborum and psoas major muscles after induction of general anesthesia Patients in group P will receive 60 ml bupivacaine 025 in the preperitoneal space from all quadrants around each trocar and will be held in trendelebergs position for 5 minutes
Technique of ultrasound guided quadradus lumborum block12 The patient will be placed in the lateral position with the side to be anesthetized turned upwards Skin preparation with povidone iodine solution will be done and curvilinear transducer will be placed in the transverse plane at the abdominal flank immediately cranial to the iliac crest Then the transducer will be moved dorsally keeping the transverse orientation until the quadratus lumborum muscle will be identified with its attachment to the lateral edge of the transverse process of the L4 vertebral body The needle will be inserted in-plane to the transducer and advanced till penetrating the ventral proper fascia of the quadratus lumborum muscle and 30 ml bupivacaine 025 will be injected between the quadratus lumborum and psoas major The procedure will be repeated on the opposite side
Technique of laparoscopic preperitoneal local anesthetic infiltration10 The patient will be placed in the supine position on the bed with both arms secured to the footboard Pneumoperitoneum will be achieved via a Veress needle at the Palmers point A camera incision will be made 16 cm from the xiphoid process and 1 cm to the left midline An 11mm port trocar was inserted a 5mm camera size will be used to explore the abdomen With the guidance of the camera the second skin incision will be made for 15mm port 1 cm proximal and 5 cm to the right of the first incision The third incision 5mm will be made 1 cm proximal and 5 cm to the left side of the patient The fourth incision 5mm will be made 1 - 3 cm to the left of the xiphoid process After skin incisions were made a Veress needle will be inserted until it reach the preperitoneal space under laparoscopic guidelines with infiltration of 60 ml of bupivacaine 025 The periperitoneum space will be infiltrated adequately from all the quadrants around each trocar Only the camera port will be infiltrated after the trocar placement The infiltration takes 20 - 30 seconds for each port
At the end of surgery awake extubation in a semi-sitting position will be done Then the patient will be transferred to the PACU In PACU all patients will be assessed for presence and severity of pain using Visual Analog Scale VAS Patients will be prescribed IV morphine 01 mgkg of lean body weight boluses on 4-6 hours basis with a maximum of 10 mg if VAS 3 Pain control in the ward will be achieved with IV paracetamol 1 g every 6 hours and ketorolac 30 mg every 12 hours Outcome assessors in PACU and ward will be blinded to patient group assignment and to the nature of the study
Measurements
The following data will be measured
I- Demographic data
Patients age years sex body mass index BMI kgm2 and co-morbidities will be recorded
II- Haemodynamic measurements
Pulse rate Beat min
Non-invasive measurement of mean arterial blood pressure in mmHg
Pulse oxygen saturation All previous parameters will be continuously monitored and recorded before induction of anesthesia after anesthesia and every 30 minutes until end of surgery
III- Intraoperative fentanyl requirements mcg IV- length of stay in PACU minutes V- Assessment of pain using VAS at 1 2 4 6 12 and 24 hours postoperatively VI- Time to first morphine dose VII- Postoperative morphine requirements mg VIII- Postoperative nausea and vomiting IX- length of hospital stay days
Blanco originally described the quadratus lumborum block QLB in 2007 The primary benefit of QLB is the extension of a local anesthetic agent beyond the transversus abdominis plane into the thoracic paravertebral area The greater distribution of local anesthetic agents may provide significant analgesia and prolong the action of the injected local anesthetic solution6
Preperitoneal local anesthetic injection was initially developed by Dean et al as a pain management strategy for laparoscopic hernia repair and it is currently widely used7 A recent meta-analysis compared preperitoneal and subcutaneous wound catheters to epidural analgesia Preperitoneal wound catheters were shown to be as effective as epidural analgesia in abdominal surgeries Periportal wound catheters appear to be more effective in terms of patient satisfaction and recovery8 A recent study concluded that preperitoneal local anesthetic infiltration is effective for relief of postoperative pain in patients undergoing laparoscopic bariatric surgery9
Aim of the work
The present study aims to compare the analgesic efficacy of ultrasound-guided trans-muscular quadratus lumborum block QLB to preperitoneal local anesthetic infiltration during laparoscopic bariatric surgery and in the early postoperative period
Primary outcome
Postoperative pain score
Secondary outcomes
Intraoperative fentanyl requirements
Postoperative morphine requirements
Time to first dose of rescue analgesia
Postoperative nausea and vomiting
Length of stay in PACU
Early mobilization
Length of hospital stay
Patients
Study settings
This study will be conducted in general surgery department Alexandria university hospitals
Study design
Double blind randomized prospective and controlled study
Sample size calculation
Based on previous study10 11 we would need a minimum sample size of 44 participants 22 in each group to reliably detect an effect size of δ 0883 assuming a two-sided criterion for detection that allows for a maximum type I error rate of a 005 that achieve 80 power
Table 1 - Sample Size and Power Analysis User Defined Group P LPLAI Group Q QLB Effect Size Power α 22 22 0883 0800 00500
The power analysis of sample size 22 in this study equals 080 this indicates there is an 80 probability that the statistical test used in our study will correctly reject the null hypothesis
Study population
All patients will be randomized 11 using a sealed envelope method Patients will be divided into two equal groups
Group Q patients will undergo laparoscopic bariatric surgery under general anesthesia and bilateral ultrasound guided quadratus lamborum block QLB
Group P patients will undergo laparoscopic bariatric surgery under general anesthesia and preincisional laparoscopic preperitoneal bupivacaine infiltration
Inclusion criteria
1 Age 20-50 years both sexes
2 ASA physical status class I to III
3 BMI 35-50 kgm²
Exclusion criteria
1 Severe cardiac disorder
2 chronic renal failure
3 liver cirrhosis
4 allergy to bupivacaine
5 patients with history of chronic opioid consumption
6 HBA1C 7
Methods
Preoperative evaluation and preparation
During preoperative visit evaluation of patients will be carried out through proper history taking clinical examination and routine laboratory investigations including complete blood picture coagulation profile blood urea serum creatinine serum electrolytes fasting blood glucose glycosylated haemoglobin HBA1C liver function tests and any other investigation needed
Pre-anesthetic preparation and premedication
Informed written consent from all individual participants who will be included in this study will be taken during preoperative visit
Patients should be trained during preoperative visit on a visual analogue scale VAS with 0 corresponding to no pain and 10 to the worst pain imaginable
Patients will be informed about the analgesic regimen
Thrombotic prophylaxis enoxaparin 40 mg will be started 12 hours before surgery
On arrival to operative theatre intravenous cannula will be inserted and standard monitoring will be established using multichannel monitor Carescape Monitor B650 GE Healthcare Finland to monitor the following in both groups
Electrocardiogram ECG for heart rate and rhythm Beatsmin
Non-invasive measurement of arterial blood pressure Mean blood pressure in mmHg
Pulse oxygen saturation SpO2
End tidal CO2 tension in mmHg
Entropy
Anesthesia
After preoxygenation for 3 minutes anesthesia will be induced in both groups with propofol 2mgkg of lean body weight until loss of verbal response fentanyl 2µgkg and atracurium 05 mgkg intravenously Anesthesia will be maintained by isoflurane with 50 oxygen in air 12-15 to maintain entropy between 40-60 Mechanical ventilation will be performed with tidal volume of 8 ml kg and a respiratory rate of 12-15 cyclesmin to maintain the end-tidal carbon dioxide tension between 35 and 40 mmHg and an oxygen saturation of 98 per cent with 50 percent oxygen in air Incremental doses of atracurium will be given every 30 minutes to maintain muscle relaxation In both groups signs of insufficient analgesia eg tachycardia over 20 of the preoperative value occur during anesthesia or somatic response eg movement tearing or sweating will be treated with additional boluses of fentanyl 05 mcgkg intraoperatively as needed Intraoperatively all patients will receive IV dexamethasone 8 mg paracetamol 1 g ketorolac 30 mg
All patients in group Q will receive bilateral injection of 30ml bupivicaine 025 between quadratus lumborum and psoas major muscles after induction of general anesthesia Patients in group P will receive 60 ml bupivacaine 025 in the preperitoneal space from all quadrants around each trocar and will be held in trendelebergs position for 5 minutes
Technique of ultrasound guided quadradus lumborum block12 The patient will be placed in the lateral position with the side to be anesthetized turned upwards Skin preparation with povidone iodine solution will be done and curvilinear transducer will be placed in the transverse plane at the abdominal flank immediately cranial to the iliac crest Then the transducer will be moved dorsally keeping the transverse orientation until the quadratus lumborum muscle will be identified with its attachment to the lateral edge of the transverse process of the L4 vertebral body The needle will be inserted in-plane to the transducer and advanced till penetrating the ventral proper fascia of the quadratus lumborum muscle and 30 ml bupivacaine 025 will be injected between the quadratus lumborum and psoas major The procedure will be repeated on the opposite side
Technique of laparoscopic preperitoneal local anesthetic infiltration10 The patient will be placed in the supine position on the bed with both arms secured to the footboard Pneumoperitoneum will be achieved via a Veress needle at the Palmers point A camera incision will be made 16 cm from the xiphoid process and 1 cm to the left midline An 11mm port trocar was inserted a 5mm camera size will be used to explore the abdomen With the guidance of the camera the second skin incision will be made for 15mm port 1 cm proximal and 5 cm to the right of the first incision The third incision 5mm will be made 1 cm proximal and 5 cm to the left side of the patient The fourth incision 5mm will be made 1 - 3 cm to the left of the xiphoid process After skin incisions were made a Veress needle will be inserted until it reach the preperitoneal space under laparoscopic guidelines with infiltration of 60 ml of bupivacaine 025 The periperitoneum space will be infiltrated adequately from all the quadrants around each trocar Only the camera port will be infiltrated after the trocar placement The infiltration takes 20 - 30 seconds for each port
At the end of surgery awake extubation in a semi-sitting position will be done Then the patient will be transferred to the PACU In PACU all patients will be assessed for presence and severity of pain using Visual Analog Scale VAS Patients will be prescribed IV morphine 01 mgkg of lean body weight boluses on 4-6 hours basis with a maximum of 10 mg if VAS 3 Pain control in the ward will be achieved with IV paracetamol 1 g every 6 hours and ketorolac 30 mg every 12 hours Outcome assessors in PACU and ward will be blinded to patient group assignment and to the nature of the study
Measurements
The following data will be measured
I- Demographic data
Patients age years sex body mass index BMI kgm2 and co-morbidities will be recorded
II- Haemodynamic measurements
Pulse rate Beat min
Non-invasive measurement of mean arterial blood pressure in mmHg
Pulse oxygen saturation All previous parameters will be continuously monitored and recorded before induction of anesthesia after anesthesia and every 30 minutes until end of surgery
III- Intraoperative fentanyl requirements mcg IV- length of stay in PACU minutes V- Assessment of pain using VAS at 1 2 4 6 12 and 24 hours postoperatively VI- Time to first morphine dose VII- Postoperative morphine requirements mg VIII- Postoperative nausea and vomiting IX- length of hospital stay days
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