| CTRI Number |
CTRI/2011/12/002267 [Registered on: 21/12/2011] Trial Registered Retrospectively |
| Last Modified On: |
17/12/2011 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Use of Ultrasound to give pain relief will be tested in patients who are morbidly obese and are undergoing surgery |
|
Scientific Title of Study
|
Efficacy of ultrasound guided transversus abdominis plane block after laparoscopic bariatric surgery : adouble blind,randomised ,controlled study |
| Trial Acronym |
USG TAP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aparna Sinha |
| Designation |
Senior Consultant |
| Affiliation |
Max Super Speciality Hospital |
| Address |
2 Press Enclave Road
Saket
New Delhi 110017
211 Sukhdev Vihar
New Delhi 110025
New Delhi
DELHI
110017
India |
| Phone |
9810035503 |
| Fax |
|
| Email |
apsin@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aparna Sinha |
| Designation |
Senior Consultant |
| Affiliation |
Max Super Speciality Hospital |
| Address |
2 Press Enclave Road
Saket
New Delhi 110017
211 Sukhdev Vihar
New Delhi 110025
New Delhi
DELHI
110017
India |
| Phone |
9810035503 |
| Fax |
|
| Email |
apsin@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aparna Sinha |
| Designation |
Senior Consultant |
| Affiliation |
Max Super Speciality Hospital |
| Address |
2 Press Enclave Road
Saket
New Delhi 110017
211 Sukhdev Vihar
New Delhi 110025
New Delhi
DELHI
110017
India |
| Phone |
9810035503 |
| Fax |
|
| Email |
apsin@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Max Super Speciality Hospital, @ press enclave road |
|
|
Primary Sponsor
|
| Name |
Max Super Speciality Hospital |
| Address |
2 Press Enclave Road
Saket
New Delhi 110017 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Aparna Sinha |
Max Institute of Minimal Access, Metabolic and Bariatric Surgery |
Max Super Speciality HospitAL, 2 PRESS eNCLAVE rOAD,NEW DELHI 110017
New Delhi
DELHI |
09810035503
apsin@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board, Max Super Speciality Hospital, DDF |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Morbidly Obese patients undergoing Bariatric Surgery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Pain Relief without TAP block |
For Post operative Pain Releif patients will be given Diclofenac sodium, Paracetamol and Tramadol Hydrochloride |
| Intervention |
Ultra Sound Guided TAP block |
Injection of 20 ml of 0.375% ropivacaine on bilaterally for Transversus Abdominis Plane block, for post operative pain refief. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
BMI> 35 Kg/m2
Either Gender
Posted for Laparoscopic bariatric surgery
Under general anaesthesia |
|
| ExclusionCriteria |
| Details |
1. Any relevant drug allergy
2. Seizure disorder
3. Antidepressants
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Requirement of Tramazac hydrochloride in first 24 hours after surgery |
Requirement of Tramazac hydrochloride in first 24 hours after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| : VAS score, RASS ((Richmond Agitation - Sedation Scale; table 1), time to ambulate, adverse events |
First 24 hours from end of surgery |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
N/A |
|
Date of First Enrollment (India)
|
03/08/2009 |
| 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="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Aims and Objectives
General anaesthesia in morbidly obese is associated with risk of multiple cardiopulmonary complications. These can be further aggravated with sedation, immobilization and hypoventilation from administration of narcotic analgesics in the postoperative period . We wished to study the analgesic potential of TAP block which produces dermatosensory block of the lower six thoracic and upper lumbar abdominal afferents , in this vulnerable group of patients .We believe this group of patients would benefit from opioid sparing effect of this block. In our literature search we did not come across any study which has evaluated the possible benefits of this block in this patient population.
Hypothesis
We hypothesised that use of ultrasound guided TAP (USG TAP) block as a part of multimodal analgesia will minimise postoperative opioid requirement, expedite ambulation and minimise adverse events in morbidly obese patients undergoing laparoscopic gastric bypass under general anaesthesia. |