| CTRI Number |
CTRI/2020/06/025940 [Registered on: 17/06/2020] Trial Registered Prospectively |
| Last Modified On: |
16/06/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Role of quadratus lumborum block for the management of pain following hernia surgery. |
|
Scientific Title of Study
|
Comparison of anterior, posterior and lateral approaches of ultrasound guided quadratus lumborum block in adult patient undergoing inguinal hernia surgery: A prospective randomized controlled trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ajeet Kumar |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, Patna |
| Address |
Department of anaesthesia,Room no-503,5th floor, OT Complex, B -Block
Patna
BIHAR
801507
India |
| Phone |
9312501413 |
| Fax |
|
| Email |
ajeetanaes@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajeet Kumar |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, Patna |
| Address |
Department of anaesthesia,Room no-503,5th floor, OT Complex, B -Block
Patna
BIHAR
801507
India |
| Phone |
9312501413 |
| Fax |
|
| Email |
ajeetanaes@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajeet Kumar |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, Patna |
| Address |
Department of anaesthesia,Room no-503,5th floor, OT Complex, B -Block
Patna
BIHAR
801507
India |
| Phone |
9312501413 |
| Fax |
|
| Email |
ajeetanaes@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, All India Institute of Medical Sciences, Patna, Phulwarisharif, Bihar, India
Pin: 801507 |
|
|
Primary Sponsor
|
| Name |
AIIMS Patna |
| Address |
Department of Anaesthesia, B-Block, OT complex |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| AIIMS Patna |
Department of Anaesthesia, B-Block, OT complex |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ajeet Kumar |
AIIMS, Patna |
Department of Anaesthesia, B-Block, OT complex
Patna
BIHAR |
9312501413
ajeetanaes@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC AIIMS Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Trans-muscular approach/ Anterior approach |
Patient will be placed in the lateral decubitus position. After local sterilization with povidone iodine, ultrasound probe covered with a sterile sheath will be placed above the iliac crest. The Petit’s triangle will be identified. The three abdominal muscles (i.e., the external oblique, internal oblique and transverses abdominus muscles) will be detected and followed posteriorly until the layers of the thoracolumbar fascia (TLF) appear as a bright hyperechogenic line. The needle will be inserted using inplane technique along the posterior edge of the probe in anteromedial direction. The needle tip will be placed between the two muscles (quadratus lumborum and psoas major muscle) after confirming the correct position of the needle and followed by negative aspiration, 2 ml of normal saline will be injected with hydro dissection, followed by 0.4 ml/kg of 2mg/ml ropivacaine. The injected local anesthetic bolus will then be seen pushing the psoas major away from the quadratus lumborum muscle. |
| Intervention |
Type 1 / Lateral approach |
The patient will be positioned lateral and a linear transducer is placed in the axial plane in the mid axillary line and moved posteriorly until the posterior aponeurosis of the transverses abdominis muscle will become visible. The target will be just deep to the aponeurosis but superficial to the transversalis fascia at the lateral margin of the QL muscle. The needle will be inserted from either the anterior or the posterior end of the transducer and advanced until the needle tip will penetrate the posterior aponeurosis of the transverses abdominis muscle. Local anesthetic will be injected between the aponeurosis and the fascia at the lateral margin of the QL muscle. |
| Comparator Agent |
Type 2 / Posterior approach |
The patient will be positioned lateral and a linear transducer will be placed in the axial plane in the mid axillary line and moved posteriorly. Then the posterior border of QL will be identified and needle tip will be placed at that point. Proper placement should result in a spread of local anesthetic through the middle of thoraco-lumbar-facial (TLF) layer and into the interfascial triangle. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA I/II
Patients undergoing for elective unilateral inguinal hernia surgery
|
|
| ExclusionCriteria |
| Details |
Refusal to give consent
ASA status of III or more
Contraindication for quadratus lumborum block like distorted anatomy
Infection at the site of injection
Coagulopathy disorder
Allergic to drug
Patient with sepsis
|
|
|
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 |
| Mean NRS score |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Total analgesic consumption
Time for first rescue analgesia required |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/06/2020 |
| Date of Study Completion (India) |
31/01/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
1. Bulka CM, Shotwell MS, Gupta RK, Sandberg WS, Ehrenfeld JM. Regional anesthesia, time to hospital discharge, and inhospital mortality: a propensity score matched analysis. RegAnesth Pain Med 2014;39:381–6
2. Liu SS, Wu CL. Effect of postoperative analgesia on major postoperative complications: a systematic update of the evidence. AnesthAnalg 2007;104:689–702
3. Bantel C, Trapp S. The role of the autonomic nervous system in acutesurgical pain processing – what do we know? Anaesthesia 2011;
66:541–544 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Quadratus lumborum block is used effectively for lower abdominal surgeries like cesarean section, pyeloplasty etc. There are various approaches for this block according to the local anaesthetic deposition. Here in this trial we will compare three different technique of quadratus lumborum block. |