| CTRI Number |
CTRI/2021/12/039016 [Registered on: 29/12/2021] Trial Registered Prospectively |
| Last Modified On: |
28/12/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
comparing two different postoperative analgesic methods-epidural technique versus a combination of analgesic methods |
|
Scientific Title of Study
|
A comparative study of multimodal analgesia with thoracic epidural for laparotomy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ANUSHA A |
| Designation |
SENIOR RESIDENT |
| Affiliation |
Sri Lakshmi Narayana Institute of Medical Sciences |
| Address |
Department of Anesthesia, Sri lakshmi narayana institute of medical sciences, Osudu lake, agaram village, Villianur commune, Koodapakkam post
Pondicherry
PONDICHERRY
605502
India |
| Phone |
9003517979 |
| Fax |
|
| Email |
anushaambal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ANUSHA A |
| Designation |
SENIOR RESIDENT |
| Affiliation |
Sri Lakshmi Narayana Institute of Medical Sciences |
| Address |
Department of Anesthesia, Sri lakshmi narayana institute of medical sciences, Osudu lake, agaram village, Villianur commune, Koodapakkam post
Pondicherry
PONDICHERRY
605502
India |
| Phone |
9003517979 |
| Fax |
|
| Email |
anushaambal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ANUSHA A |
| Designation |
SENIOR RESIDENT |
| Affiliation |
Sri Lakshmi Narayana Institute of Medical Sciences |
| Address |
Department of Anesthesia, Sri lakshmi narayana institute of medical sciences, Osudu lake, agaram village, Villianur commune, Koodapakkam post
Pondicherry
PONDICHERRY
605502
India |
| Phone |
9003517979 |
| Fax |
|
| Email |
anushaambal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Lakshmi Narayana Institute of Medical Sciences, Puducherry. |
|
|
Primary Sponsor
|
| Name |
Sri Lakshmi Narayana Institute of Medical Sciences |
| Address |
Osudu lake, Agaram village, Koodapakam post, Villianur commune, Pondicherry-605502. |
| 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 |
| ANUSHA A |
major operation theaSri Lakshmi Narayana Institute of Medical Sciences |
major operation theatres, Department of Anesthesia, General surgery and Gynecology, Osudu lake, Agaram village, Koodapakam post, Villianur commune, Pondicherry-605502.
Pondicherry
PONDICHERRY |
9003517979
anushaambal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Epidural analgesia post-laparotomy |
Patients will receive Ringer lactate infusion @ 10ml/kg over 20 minutes before epidural catheter insertion. Patient will be placed in right lateral position and epidural catheter placed according to institutional protocol. Epidural anesthesia will be performed by a skilled anesthesiologist who is not included in the study and test dose will be given for confirming correct placement of the catheter. They will undergo laparotomy under general anesthesia with epidural analgesia. Group E patients will be receiving epidural top up with 0.125% Bupivacaine 12ml according to the hemodynamics intraoperatively and every 6 hours postoperatively (the first dose at the post-wound-closure, prior to extubation stage). |
| Comparator Agent |
Multimodal analgesia post-laparotomy |
Patients will receive 0.125% Bupivacaine 15 ml infiltration at the incision site post operatively before the closure of wound, and ultrasound guided Transversus Abdominis Plane (TAP) block with 0.125% Bupivacaine 15ml on each side after closure of the surgical site, in addition to this, Group M will receive 15mg/kg dose of Inj.Paracetamol infusion every 6 hours postoperatively (the first dose) prior to extubation of endotracheal tube. In this group infiltration analgesia will be given by a skilled surgeon according to the instructions of a skilled anesthesiologist and will not be part of the study. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA I & II PATIENTS
SURGERY DURATION WITHIN 4 HOURS |
|
| ExclusionCriteria |
| Details |
KNOWN ALLERGY/HYPERSENSITIVITY TO DRUGS USED
LOCAL SKIN SITE INFECTION
COAGULOPATHY
PRE-EXISTING ACUTE/CHRONIC PAIN
PREVIOUS ABDOMINAL SURGERIES
PATIENTS WITH SIGNIFICANT CARDIAC, PULMONARY, HEPATIC DISEASES |
|
|
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 |
1)To estimate the time of request of first rescue analgesic
2) To estimate the total dose of rescue analgesic consumed in the early postoperative period |
48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To estimate the incidence of hypotension, nausea and vomiting |
48 hours |
|
|
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)
|
03/01/2022 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A double-blinded, prospective study with hundred patients will be divided randomly into two groups of fifty each: Group E will be given epidural analgesia, Group M will be given multimodal analgesia for their post-laparotomy period. Both the groups will be monitored for 48 hours postoperatively. The parameters recorded will be blood pressure, pulse rate, saturation, visual analog scale for pain scores every hour. Whenever the visual analog score crosses 4, patients will be given rescue analgesic. The total number of rescue analgesics required in both groups will be recorded for 48 hours postoperatively. |