| CTRI Number |
CTRI/2011/11/002159 [Registered on: 22/11/2011] Trial Registered Retrospectively |
| Last Modified On: |
28/03/2019 |
| 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
|
Comparison of local anesthetic injection at nerve plane with direct injection at surgical wound in lower abdominal surgeries |
|
Scientific Title of Study
|
Comparison of analgesic efficacy of transversus abdominis plane block with direct infiltration of local anesthetic into surgical incision in lower abdominal surgeries - a randomized controlled clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
VijayalakshmiSivapurapu |
| Designation |
Senior Resident |
| Affiliation |
JIPMER (Jawaharlal Institute of Postgraduate Medical Education and Research) |
| Address |
Plot 7 & 8, Logu nagar, Gorimedu, Pondicherry
JIPMER, Gorimedu, Pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
04132276549 |
| Fax |
|
| Email |
prerana10@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
VijayalakshmiSivapurapu |
| Designation |
Senior Resident |
| Affiliation |
JIPMER (Jawaharlal Institute of Postgraduate Medical Education and Research) |
| Address |
Plot 7 & 8, Logu nagar, Gorimedu, Pondicherry
JIPMER, Gorimedu, Pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
04132276549 |
| Fax |
|
| Email |
prerana10@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
VijayalakshmiSivapurapu |
| Designation |
Senior Resident |
| Affiliation |
JIPMER (Jawaharlal Institute of Postgraduate Medical Education and Research) |
| Address |
Plot 7 & 8, Logu nagar, Gorimedu, Pondicherry
JIPMER, Gorimedu, Pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
04132276549 |
| Fax |
|
| Email |
prerana10@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institue of Postgraduate Medical Education and Research JIPMER |
| Address |
Gorimedu
Pondicherry-605006 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DrAshok Badhe |
Head of Department & Professor, Anesthesiology & Critical care, JIPMER, Pondicherry - 605006 |
| DrSumanlataG |
Assistant Professor, Department of Anesthesiology & Critical acre, JIPMER, Pondicherry -605006 |
| DrVasudevanA |
Assistant Professor, Department of Anesthesiology & Critical care, JIPMER, Pondicherry - 605006 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vijayalakshmi Sivapurapu |
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) |
Gorimedu, Pondicherry-605006
Pondicherry
PONDICHERRY |
09442176549
prerana10@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee (Human studies) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N852||Hypertrophy of uterus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Direct infiltration of local anesthetic into surgical wound |
Local anesthetic - Bupivacaine 0.25% 0.6ml/kg Single Injection at the Surgical incision as infiltration. The study is to find the duration of action |
| Intervention |
Transverse abdominal plane block with local anesthetic |
Local anesthetic Bupivacaine 0.25% 0.6ml/kg Single injection at the Transversus Abdominal Plane via the Triangle of Petit. Intervention is done to find the duration of action |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
ASA I - II,
Patients undergoing lower abdominal procedures under general anesthesia |
|
| ExclusionCriteria |
| Details |
Patients with known allergies to local anesthetics
Patients who are unwilling |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time to first rescue analgesic |
Time at which patient complains of pain |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 24 hour morphine requirement |
24 hours |
| Nausea |
At 2, 4, 6, 24 hours |
| Sedation |
At 2, 4, 6, 24 hours |
| Visual Analog Score(VAS) |
AT 2, 4, 6, 24 hours |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/07/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Transverse abdominis plane (TAP) block has been used for effective postoperative pain relief for various abdominal surgeries. Efficacy of this block has been proven in retropubic prostatectomy surgeries, large bowel resection surgeries, total abdominal hysterectomies as well as in cesarean sections. Infiltration of surgical incision with local anesthetic is done in various surgeries with effective pain relief. Comparison of both these methods would give an idea as to which one of these is more effective and also lasts for a longer duration. |