| CTRI Number |
CTRI/2018/08/015412 [Registered on: 23/08/2018] Trial Registered Prospectively |
| Last Modified On: |
17/08/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing pain relief with continuous pain killer infusion for 24 hours given through tubes placed in abdominal wall and continuous pain killer infusion given through tube placed in lower back region following abdominal surgery |
|
Scientific Title of Study
|
Comparison of Transversus Abdominis Plane (TAP) block with Epidural analgesia for post-operative pain relief following abdominal surgeries - 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 Mamidala Srinivas |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Institute of Post Graduate Medical Education and Research |
| Address |
Department of General Surgery,
JIPMER Hospital,
Dhanvantri nagar,
Pondicherry.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9655666749 |
| Fax |
|
| Email |
drcnu93996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sarath Chandra Sistla |
| Designation |
Professor |
| Affiliation |
Jawaharlal Institute of Post Graduate Medical Education and Research |
| Address |
Department of General Surgery,
JIPMER Hospital,
Dhanvantri nagar,
Pondicherry.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
|
| Fax |
|
| Email |
sarathsistla@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sarath Chandra Sistla |
| Designation |
Professor |
| Affiliation |
Jawaharlal Institute of Post Graduate Medical Education and Research |
| Address |
Department of General Surgery,
JIPMER Hospital,
Dhanvantri nagar,
Pondicherry.
Mahe
PONDICHERRY
605006
India |
| Phone |
|
| Fax |
|
| Email |
sarathsistla@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Intramural Fund, JIPMER Hospital,
Dhanvantri Nagar, Pondicherry-605006 |
|
|
Primary Sponsor
|
| Name |
JIPMER |
| Address |
JIPMER Hospital,
Dhanvantri Nagar
Pondicherry-605006 |
| 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 |
| Dr Mamidala Srinivas |
JIPMER |
Jipmer Hospital
Dhanvantri Nagar
Pondicherry-605006
Pondicherry
PONDICHERRY |
9655666749
drcnu93996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee( Human Studies) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
All patients more than 18 years planned for elective abdominal surgery will be included, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Epidural analgesia |
pain relief using VAS score. surgical stress using inflammatory markers Total leukocyte count, IL-6 and CRP will be measured in the preoperative , immediate post op and 24 hour post operative period and compared with TAP block group |
| Intervention |
Transverse abdominis plane block |
pain relief using VAS score.
surgical stress using inflammatory markers Total leukocyte count, IL-6 and CRP will be measured in the preoperative , immediate post op and 24 hour post operative period and compared with epidural group |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
patients more than 18 years
Elective Open abdominal surgeries
American society of anesthesiologists (ASA) I, II and III. |
|
| ExclusionCriteria |
| Details |
Allergy to local anesthetist
Pregnancy
Patients on anti-coagulants
Patients on Pre-op opiods usage
Patients who do not comprehend VAS |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain relief by Visual Analogue Scale Score( Scale 0-10) |
6 hours, 12 hours and 24 hours post op. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Total leukocyte count, Interleukin-6, C- reactive protein measurement |
preoperative, immediate post op and 24 hours post operative period |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
01/09/2018 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Post-operative pain management after surgery remains challenging for very surgeon. Studies have shown that 86% of post operative patients have moderate to extreme pain after surgery. Epidural analgesia is a commonly used method for post operative pain management in abdominal surgery. In addition to pain relief, epidural analgesia also has some beneficial effects like reduction in pest operative ileus and surgical stress response. But it is associated with complications like hypotension events, oliguria, risk of central nervous system and systemic infections, dural puncture or epidural hematoma. Teansversus abdominis plane block is increasingly used for pain relief following abdominal surgeries. It also has some beneficial effects on post-operative paralytic ileus. TAP block is relatively easy to perform, safe, unlike epidural analgesia, and can be performed even in patients who are on anti-coagulation therapy. |