| CTRI Number |
CTRI/2020/02/023230 [Registered on: 10/02/2020] Trial Registered Prospectively |
| Last Modified On: |
24/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare effect of two different pain relieving blocks in patients undergoing laparoscopic inguinal hernia surgery |
|
Scientific Title of Study
|
Comparison of analgesic efficacy of two different fascial blocks in patients undergoing laparoscopic inguinal hernia surgery : a 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 Aastika Mahajan |
| Designation |
Junior resident |
| Affiliation |
Government medical college and hospital ,Chandigarh |
| Address |
D block level 5
Government medical college and hospital Chandigarh sector 32
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9779722168 |
| Fax |
|
| Email |
aastikamahajan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vanita Ahuja |
| Designation |
Associate Professor |
| Affiliation |
Government medical college and hospital Chandigarh |
| Address |
D block level 5
Department of Anaesthesia
Government medical college and hospital Chandigarh sector 32
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121649 |
| Fax |
|
| Email |
vanitaanupam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vanita Ahuja |
| Designation |
Associate Professor |
| Affiliation |
Government medical college and hospital Chandigarh |
| Address |
D block level 5
Department of Anaesthesia
Government medical college and hospital Chandigarh sector 32
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121649 |
| Fax |
|
| Email |
vanitaanupam@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government medical college and hospital sector 32 Chandigarh |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesia and intensive care |
| Address |
Government medical college and hospital sector 32 Chandigarh |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Dr Vanita Ahuja |
Government medical college and hospital |
D block level 5
Dept of Anaesthesia and Intensive Care
GMCH, SECTOR 32
Chandigarh
Chandigarh
CHANDIGARH |
9646121649
vanitaanupum@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical Committee (Gmch, Chandigarh) |
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, (2) ICD-10 Condition: K402||Bilateral inguinal hernia, withoutobstruction or gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Retrolaminar block |
20 ml of 0.375% ropivacaine on each side |
| Comparator Agent |
Transversus abdominis plane block |
20 ml of 0.375 % ropivacaine on each side |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA I - II
Patient scheduled for elective laparoscopic inguinal hernia surgery |
|
| ExclusionCriteria |
| Details |
BMI > 40kg/m2
Coagulopathy
Allergic to Ropivacaine, paracetamol and diclofenac
Pregnant and lactating women
Substance abuse
Not able to understand VAS score
Contraindication to general anaesthesia or laparoscopic surgery
|
|
|
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 |
| Postoperative cumulative pain score on movement following blocks |
at 24 hr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time for first use of rescue analgesia |
baseline, 5 min, 10 min, 15 min, 1hr, 8hr, 12hr, 18hr, 24hr |
| Total dose of rescue analgesic |
baseline, 5 min, 10 min, 15 min, 1hr, 8hr, 12hr, 18hr, 24hr |
| Haemodynamics (pulse rate, mean arterial pressure, respiratory rate, spo2) |
baseline, 5 min, 10 min, 15 min, 1hr, 8hr, 12hr, 18hr, 24hr |
| Patient satisfaction score |
24hr |
| VAS score at rest |
baseline, 5 min, 10 min, 15 min, 1hr, 8hr, 12hr, 18hr, 24hr |
| VAS score at movement |
baseline, 5 min, 10 min, 15 min, 1hr, 8hr, 12hr, 18hr, 24hr |
| Follow up |
At 1 month |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
Final Enrollment numbers achieved (Total)= "42"
Final Enrollment numbers achieved (India)="42" |
|
Phase of Trial
|
Post Marketing Surveillance |
Date of First Enrollment (India)
Modification(s)
|
18/02/2020 |
| Date of Study Completion (India) |
29/11/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The present study was conducted in the Department of Anaesthesia and Intensive Care, in collaboration with the Department of Surgery, Government medical college and hospital, Chandigarh. Study has been approved from hospital ethics committee and now registered with CTRI. Informed written consent from 42 patients of either gender, scheduled to undergo laparoscopic inguinal hernia surgery under general anaesthesia after fulfilling inclusion and exclusion criteria will be taken.Study design: prospective, randomized controlled trial After the surgery before extubation of trachea patients will be randomised to receive either ultrasound guided transverses abdominis plane block or retrolaminar block. 20ml of 0.375% of ropivacaine will be given on each side. Postoperatively for 24hr patients will followed up for VAS score, total analgesic use, haemodynamics, patient satisfaction score and any other adverse effects. Patients will be evaluated postoperatively for pain score and patient satisfaction score at 1 month of follow up. |