| CTRI Number |
CTRI/2017/10/010264 [Registered on: 31/10/2017] Trial Registered Prospectively |
| Last Modified On: |
13/07/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare analgesic efficacy of two truncal blocks:TAP and QL block in laparoscopic inguinal hernia surgeries
|
|
Scientific Title of Study
|
To compare analgesic efficacy of bilateral Quadratus Lumborum block vs Transversus Abdominis Plane block in patients undergoing laparoscopic Trans-abdominal Pre-peritoneal repair of inguinal hernia: a randomised control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
AVISHEK ROY |
| Designation |
junior resident |
| Affiliation |
AIIMS, NEW DELHI |
| Address |
Ansari nagar, new delhi, AIIMS
ANSARI NAGAR, DELHI-110029
New Delhi
DELHI
110029
India |
| Phone |
9038516090 |
| Fax |
|
| Email |
roy.avishek1992@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Debesh Bhoi |
| Designation |
assistant professor |
| Affiliation |
AIIMS, NEW DELHI |
| Address |
AIIMS, Ansari nagar, new delhi
Ansari Nagar, Delhi-110029
New Delhi
DELHI
110029
India |
| Phone |
7042129428 |
| Fax |
|
| Email |
debeshbhoi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
AVISHEK ROY |
| Designation |
junior resident |
| Affiliation |
AIIMS, NEW DELHI |
| Address |
AIIMS, Ansari nagar, new delhi
ANSARI NAGAR, DELHI-110029
New Delhi
DELHI
110029
India |
| Phone |
9038516090 |
| Fax |
|
| Email |
roy.avishek1992@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS HOSPITAL, Ansari nagar, new delhi |
|
|
Primary Sponsor
|
| Name |
AIIMS hospital |
| Address |
Ansari nagar, New delhi |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| AVISHEK ROY |
All India Insitute Of Medical sciences |
Ansari nagar, NEW DELHI
New Delhi
DELHI |
9038516090
roy.avishek1992@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee,AIIMS |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
ASA-1/2 patients, aged 18-65 years undergoing uni/bilateral inguinal hernia repair by TAPP approch. both sexes included, (1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Quadratus lumborum block |
truncal block applied as apart of multimodal analgesia in many surgeries. we will use transmuscular approach of Quadratus Lumborum block where local anesthetic( 20 ml of 0.25 % ropivacaine each side) will be injected under USG guidance between quadratus lumborum and psoas major muscle |
| Comparator Agent |
Trasnversus Abdominis Plane block |
well established truncal block technique. we will use posterior approach where local anesthetic (20 ml of 0.25% Ropivacaine) will be injected in between internal oblique and transversus abdominis muscle of abdomen. block will be done under USG guidance and through lumabr traingle of petit. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and 2, both unilateral and bilateral inguinal hernia |
|
| ExclusionCriteria |
| Details |
refusal to consent, BMI>35 kg/m2, history of allergy to local anesthetic, history of neurological or psychiatric disorder, active infection at the site of injection, bleeding diathesis-platelet count<100,00/mm3 and/or INR>1.5, patients unable to comprehend use of PCA pump, patients with recurrent or complicated hernia |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the intraoperative and post-operative Fentanyl consumption over 24 hours of surgery |
24 hours post-operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| assessment of dermatomal coverage by 3 point scale |
upto 30 minutes |
| calculate total performance time in each group |
during blocks |
| observation of lower limb weakness |
24 hours |
| time to first analgesic requirement indicated by the time when patient presses PCA button |
immediate post operative period |
| comparison of NRS score between the two group |
after awakenig,1hr, 2hr, 4 hr, 6hr,12 hr, 24 hr |
| quality of recovery at 24 hours by QoR-40 questionnaire |
24 hours |
| quality of life assessment by SF-36 questionnaire |
3 months post-operatively |
| incidence of post-operative nausea and vomitting |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "42"
Final Enrollment numbers achieved (India)="42" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/11/2017 |
| Date of Study Completion (India) |
25/03/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
25/03/2019 |
|
Estimated Duration of Trial
|
Years="1"
Months="11"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
This study has bagged first prize as poster presentation in PG assembly organised by department of anesthesia in AIIMS New Delhi in September, 2019. It has not been written as a papaer yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
After completion of the study, we found that patients in QL group had lesser perioperative fentanyl requirements and longer lasting analgesia as compared to patients in TAP group. Post operative pain scores and comparison of quality of life assessed by QOR-SF-36 at 3 months post operatively were comparable. thus, we concluded that QL block was better in terms of perioperative analgesia in patents undergoing laparoscopic TAPP repair of inguinal hernia. There was no observable adverse effect to preclude the study. The study was printed in the form of thesis dissertation in June 2019 and accepted by AIIMS ethical board before final MD examination. |