| CTRI Number |
CTRI/2025/08/093587 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
22/08/2025 |
| 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
|
A study on two pain control techniques in laparoscopic diversion colostomy- TAP Block vs Local wound infiltration |
|
Scientific Title of Study
|
Bilateral Transverse Abdominis Plane Block versus Local Wound Infiltration for postoperative analgesia in patients undergoing Laparoscopic Diversion Colostomy- A Randomized Control Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sophia Nag |
| Designation |
PG Registrar |
| Affiliation |
Christian Medical College |
| Address |
Department of Anesthesia
Christian Medical College
Vellore 632004
Tamil Nadu
Vellore
TAMIL NADU
632004
India |
| Phone |
8917254911 |
| Fax |
|
| Email |
sops9615@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tony Thomson Chandy |
| Designation |
Professor |
| Affiliation |
Christian Medical College |
| Address |
Department of Anesthesia
Christian Medical College
Vellore 632004
Tamil Nadu
Vellore
TAMIL NADU
632004
India |
| Phone |
8917254911 |
| Fax |
|
| Email |
tonythomson@cmcvellore.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sophia Nag |
| Designation |
PG Registrar |
| Affiliation |
Christian Medical College |
| Address |
Department of Anesthesia
Christian Medical College
Vellore 632004
Tamil Nadu
Vellore
TAMIL NADU
632004
India |
| Phone |
8917254911 |
| Fax |
|
| Email |
sops9615@gmail.com |
|
|
Source of Monetary or Material Support
|
| Christian Medical College Vellore, Vellore
Tamil Nadu 632004
India |
|
|
Primary Sponsor
|
| Name |
Fluid Research Grant |
| Address |
Office of Research, Christian Medical College Vellore
Tamil Nadu 632002 |
| Type of Sponsor |
Private 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 Sophia Nag |
Christian Medical College |
Department of Anesthesia
Christian Medical College Vellore
Tamil Nadu 632004
Vellore
TAMIL NADU |
8917254911
sops9615@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Silver Ethics and Research Comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K639||Disease of intestine, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Local Wound Infiltration |
Local wound infiltration with 40ml of 0.2% Ropivacaine in patients undergoing Laparoscopic Diversion Colostomy at the port sites by the surgeons immediately post surgery.Then the VAS scores will be measured immediately post op in PACU, 2 hours, 4 hours, 6 hours and 12 hours. The values will be compared with that of the intervention group. The toal duration of the study is 1 year |
| Intervention |
Ultrasound Guided Bilateral Transverse Abdominis Plane Block |
Administration of Bilateral Ultrasound guided Transverse Abdominis Plane Block in patients undergoing Laparoscopic Diversion colostomy with 20ml of 0.2% Ropivacaine on each side immediately post op before shifting the patient to PACU and then checking the VAS scores immediately post op in PACU, 2hours, 4hours, 6 hours and 12 hours. The entire study will be completed in 1 year |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All consenting and hemodynamically stabel patients undergoing laparoscopic diversion colostomy |
|
| ExclusionCriteria |
| Details |
Non consenting patients, patient with history of adverese events with local anesthetics, infection at site of infiltration, long term opoid use, impaired coagulation profile and ASA 4 and above. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To provide longer and superior post operative pain relief for patients undergoing laparoscopic diversion colostomy by using TAP Block as opposed to local wound infiltration |
Post op pain will be assessed using the VAS scores in the first 12 hours i.e. on shifting the patient to recovery, 2 hours, 4 hours, 8 hours and 12 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To measure the requirement of post op opioids |
Need of opioids postoperatively in recovery & in the first 12 hours. |
| To measure the difference in peak expiratory flow rate preoperatively & compare post operatively in both study arms |
Preoperative PEFR will be measured in the ward or holding bay for baseline values & compared with post operative PEFR measured in ward after 2 hours, 4 hours, 8 hours & 12 hours. |
| To evaluate the length of hospital stay |
Postoperative length of hospital stay |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
10/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Postoperative analgesia is important for enhanced recovery. Although laparoscopic surgeries have reduced the incision and pain in colorectal surgeries, postoperative pain is still an issue. Opioid based analgesia is generally used for pain management, however it can lead to increased incidences of post op nausea, vomiting, urinary retention, constipation etc. This study aims to compare the effectiveness of a bilateral TAP Block to opt for opioid free analgesic modalities and reduce the effects related to opioids after surgery. Patients undergoing laparoscopic diversion colostomy will be recruited for this study after obtaining for the study. This will be a randomized control trial and a double blinded study in which the patient and the primary investigator will be blinded. All the patients undergoing the surgery will be allotted a computer generated randomized number that will decide whether the patient will receive local wound infiltration or a TAP Block. The patient wil then be followed up in PACU and surgical wards. Postoperative pain intensity, opioid consumption, PEFR and occurence of any adverse events following the block and length of hospital stay will be evaluated in both arms. |