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CTRI Number  CTRI/2015/05/005831 [Registered on: 29/05/2015] Trial Registered Prospectively
Last Modified On: 27/04/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To assess pain relief after gynaecological laparoscopic (keyhole) surgery using two ultrasound guided regional anaesthesia techniques, TAP block or Quadratus lumborum block 
Scientific Title of Study   To compare the analgesic efficacy of ultrasound guided quadratus lumborum block to ultrasound guided transversus abdominis plane (TAP) block in patients undergoing operative laparoscopic gynaecological procedures under general anaesthesia 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anjolie Chhabra 
Designation  Additional Professor Anaesthesiology 
Affiliation  All India Institute of Medical Sciences 
Address  Room no. 5013, 5th Floor Teaching Block, Department of Anaesthesiology & Intensive Care, All India Institute of Medical Sciences, Ansari Nagar, New Delhi
Ansari Nagar, New Delhi
New Delhi
DELHI
110029
India 
Phone  01126593212  
Fax  01126588641  
Email  anjolie5@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rohit Chaudhary 
Designation  Junior Resident Anaesthesiology 
Affiliation  All India Institute of Medical Sciences 
Address  Room no. 5011, 5th Floor Teaching Block, Department of Anaesthesiology & Intensive Care, All India Institute of Medical Sciences, Ansari Nagar, New Delhi
Ansari Nagar, New Delhi
New Delhi
DELHI
110029
India 
Phone  01126593212  
Fax  0112658864  
Email  chaudhary_rohit77@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Anjolie Chhabra 
Designation  Additional Professor Anaesthesiology 
Affiliation  All India Institute of Medical Sciences 
Address  Room no. 5013, 5th Floor Teaching Block, Department of Anaesthesiology & Intensive Care, All India Institute of Medical Sciences, Ansari Nagar, New Delhi
Ansari Nagar New Delhi
New Delhi
DELHI
110029
India 
Phone  01126593212  
Fax  0112658864  
Email  anjolie5@hotmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, New Delhi 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences New Delhi 
Address  Ansari Nagar New Delhi 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anjolie Chhabra  All India Institute of Medical Sciences  Department of Anaesthesiology and Intensive Care, Main OT and AB8 Recovery room, AIIMS Hospital, Ansari Nagar New Delhi
New Delhi
DELHI 		 01126593212
01126588641
anjolie5@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
All India Institute of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  ASA grade I & II female patients aged 18-65 years scheduled to undergo operative laparoscopic gynaecological surgery under general anaesthesia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  ultrasound guided quadratus lumborum block  In the anaesthesia room after attaching routine monitors the baseline heart rate (HR), electrocardiogram (ECG), oxygen saturation (SpO2), non invasive blood pressure (NIBP) will be monitored. Intravenous access will be established. Oxygen by face mask will be administered. The patient will be premedicated with 1-1.5mg midazolam IV and boluses of fentanyl (25μg IV). After this patient will be randomly allocated to either QL group or TAP group by opening of sealed,opaque envelopes by an anaesthesiologist who is not a part of the study. The respective blocks will be given after ensuring asepsis and providing skin anaesthesia by infiltration of local anaesthetic (2ml of 2% lignocaine with adrenaline 1:200,000) before placement of the block needle. 
Comparator Agent  ultrasound guided transversus abdominis plane (TAP) block  Similarly in the control group after attaching routine monitors, taking baseline values of haemodynamics, the patient will be randomly allocated to either QL group or TAP group by opening of sealed,opaque envelopes by an anaesthesiologist who is not a part of the study. The respective blocks will be given after ensuring asepsis and providing skin anaesthesia by infiltration of local anaesthetic (2ml of 2% lignocaine with adrenaline 1:200,000) before placement of the block needle. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  ASA grade I & II female patients aged 18-65 years scheduled to undergo operative laparoscopic gynaecological surgery under general anaesthesia 
 
ExclusionCriteria 
Details  1.Patient refusal to participate in the study
2. Age <18 years or >65 years
3. ASA class 3,4 or 5 patients
4. Morbid obesity (BMI ≥ 35).
5. History of hypersensitivity or allergy to local anaesthetics
6. Patients with infection at the site of proposed block
7. Bleeding diathesis; INR more than 1.5 and platelet count less than 100,000/mm3
8. Inability to comprehend the VAS pain assessment scale. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the PCA fentanyl requirement in the first 6 postoperative hours between the ultrasound (USG) guided bilateral quadratus lumborum (QL) block and USG bilateral transversus abdominis plane (TAP) block.  In the first 6 postoperative hours. 
 
Secondary Outcome  
Outcome  TimePoints 
Comparison in between the groups:
1. VAS scores at rest and with movement (deep breathing) at 0, 1, 2, 4, 6, 12 and 24 hours postoperatively.
2. Time to first rescue analgesia requirement postoperatively, indicating the duration of the block.
3. Assessment of time to fitness for discharge of patient from PACU to ward assessed by VAS score 30, modified Aldrete Score9 and no PONV.
4. Total 24 hours analgesic requirement.
5. Quality of recovery score at 24 hours. 		 First 24 postoperative hours. 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   01/07/2015 
Date of Study Completion (India) 30/09/2016 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Not yet published. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

The increasing use of laparoscopic surgery in modern surgery has led to its widespread use for gynaecological procedures as well. Myomectomy, hysterectomy, cystectomy, salpingo-oophorectomy, salpingectomy and sacral colpopexy are some of the procedures being performed by laparoscopy in the present day.

Laparoscopic surgery has resulted in reducing postoperative pain and improving patient mobilization as compared to open surgery1,2. However, moderate to severe peri- operative pain does occur following major laparoscopic surgery which can interfere with patient mobilization and recovery3. This pain is attributed to the port site incisions and also to the intra-operative peritoneal stretching and visceral handling. Shoulder tip pain due to pneumo-peritoneum has also been reported4.

The use of opioids as a part of multimodal analgesia together with acetaminophen and non steroidal anti inflammatory drugs (NSAIDs) is the standard analgesic regimen for these procedures. The use of opioids however is associated with sedation, post operative nausea and vomiting, respiratory depression and urinary retention. This has led to the incorporation of peripheral nerve block techniques for providing peri-operative analgesia in patients undergoing laparoscopic surgery5.

Bilateral transversus abdominis block (TAP) block is one such technique that has been developed in order to provide peri-operative analgesia. The TAP block has been shown to be useful in the treatment of pain after abdominal wall surgery5. Numerous studies have shown that the TAP block, when used as part of a multimodal analgesic regimen, is an effective component in reducing patients’ postoperative pain scores6,7,8.

In TAP block, infiltration of local anaesthetic agents in the plane between the internal oblique and the transversus abdominis muscle results in blockade of the somatic nerves

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innervating the anterior abdominal wall. Recent reviews have reported more prolonged analgesia with the extension of the local anaesthetic into the paravertebral space as seen with the landmark guided or posterior TAP block10.

The Quadratus Lumborum (QL) block is a newer modification of the TAP block concept that includes deposition of injectate adjacent to the antero-lateral aspect of the QL muscle. The spread pattern obtained by QL block is comparable to that of the landmark-based TAP block, in that there is extension into the thoracic paravertebral space10. The transmuscular approach to the QL block with the needle tip positioned anterior to the quadratus lumborum muscle but posterior to the psoas major muscle has shown to be more successful as the spread of local anaesthetic to the thoracic paravertebral space seems to be of crucial importance for the efficacy of posterior TAP blocks11.

The QL muscle and the psoas major muscle have their embryonic origin in the thoracic cage. Their close proximity to the transversalis fascia and the endothoracic fascia may be responsible for the proposed spread of the local anaesthetic to the thoracic paravertebral space. This enables the potential of the QL block to produce somatic as well as visceral analgesia.

This study aims to ascertain whether USG quadratus lumborum block would result in better pain relief as compared to standard multimodal analgesic regimen that includes TAP block for adult patients undergoing operative laparoscopic gynaecological procedures under general anaesthesia. 

 
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