CTRI Number |
CTRI/2020/11/029351 [Registered on: 25/11/2020] Trial Registered Prospectively |
Last Modified On: |
15/11/2020 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
postoperative pain relief in lower abdominal surgery patients using either tranversis abdominis plane block or epidural analgesia |
Scientific Title of Study
|
comparative study of transverse abdominis plane block versus epidural analgesia in post operative pain management following lower abdominal surgery |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Shyjar babu j |
Designation |
Junior Resident |
Affiliation |
Azeezia Medical College |
Address |
Department of Anesthesia
Azeezia Medical College
Kollam Diamond hills
Meeyanoor
Kollam Kollam KERALA 691537 India |
Phone |
9633841122 |
Fax |
|
Email |
shyjarbabu@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Shyjar babu J |
Designation |
Junior Resident |
Affiliation |
Azeezia Medical College |
Address |
Department of Anesthesia
Azeezia Medical College
Kollam Diamond Hills
Meeyanoor
Kollam Kollam KERALA 691537 India |
Phone |
9633841122 |
Fax |
|
Email |
shyjarbabu@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr George K George |
Designation |
Professor and HOD |
Affiliation |
Azeezia Medical College |
Address |
Department of Anesthesia
Azeezia Medical College
Kollam Diamond hills
Meeyanoor
Kollam Kollam KERALA 691537 India |
Phone |
8921762254 |
Fax |
|
Email |
drgeorgekg@gmail.com |
|
Source of Monetary or Material Support
|
azeezia medical college
kollam |
|
Primary Sponsor
|
Name |
Azeezia Medical College |
Address |
Diamond Hills
Meeyanoor
Kollam |
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 Shyjar babu J |
Azeezia Medical Collage , Kollam |
OT complex
Department of anesthesia Kollam KERALA |
9633841122
shyjarbabu@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
azeezia ethics committe |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: K928||Other specified diseases of the digestive system, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
epidural analgesia |
administering local analgesic in epidural space with 0.25 % bupivacaine 0.3 ml/kg for postoperative pain relief |
Intervention |
transversis abdominus plane block |
administering local anestehtic to transversis abdominis plane with 0.125 % bupivacaine 0.5 ml/kg for postoperative analgesia |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
75.00 Year(s) |
Gender |
Both |
Details |
Adult patients ASA 1 and ASA 2 undergoing lower
abdominal surgeries under general anaesthesia
|
|
ExclusionCriteria |
Details |
1. Refusal to consent
2. Contraindication to TAP block and epidural analgesia such as
a) soft-tissue infection of the abdominal wall and skin;
b) patients suffering from coagulopathy
c) those requiring postoperative mechanical ventilation;
|
|
Method of Generating Random Sequence
|
Random Number Table |
Method of Concealment
|
Case Record Numbers |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
post operative pain relief |
3rd 6th and 9th hour postoperatively |
|
Secondary Outcome
|
Outcome |
TimePoints |
rescue analgesia consumption |
3rd 6th and 9 th hour postoperatively |
|
Target Sample Size
|
Total Sample Size="32" Sample Size from India="32"
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)
|
15/12/2020 |
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
|
not yet published |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Postoperative pain control after surgery is one of the basic medical issues and challenges. Most patients who had undergone surgical procedures experience acute postoperative pain, but evidence suggests that less than half of them report adequate postoperative pain relief. Routinely the opioids are used for pain control after surgery; however, the widespread use of opioids has numerous side effects and delay postoperative recovery. According to the World Health Organization guidelines, the excessive use of opioids decreases the patients’ satisfaction. Epidural analgesia is considered to be the most effective method of pain relief and is often the preferred choice of analgesia. In search a regional technique for effective post-operative analgesia transverse abdominis plane block provide post-operative analgesia with decreased systemic effect. It is relatively simple and efficacious. It has been reported to significantly reduce pain associated with lower abdominal surgery, regardless of whether it is used as the primary anaesthetic or for pain control after general anaesthesia . Tap block along with reduction in postoperative pain, it also decreases analgesic drug usage. |