| CTRI Number |
CTRI/2024/03/064260 [Registered on: 18/03/2024] Trial Registered Prospectively |
| Last Modified On: |
15/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Pain Relief] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparing the postoperative pain using two different methods of
local analgesia (one method by Laparoscopy and the other with Ultrasound) in laparoscopy for
colorectal surgery. |
|
Scientific Title of Study
|
Comparison of early postoperative analgesia between LTAP (Laparoscopic assisted Transversus
Abdominus Plane) block and USG-RS (ultrasound guided Rectus Sheath) block in laparoscopic
colorectal surgery – Randomized control trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrSavarinjebha J |
| Designation |
PG Registrar |
| Affiliation |
Christian Medical College |
| Address |
Junior Resident,
Department of Anaesthesiology ,
Christian Medical College ,
Vellore-632004.
Vellore
TAMIL NADU
632004
India |
| Phone |
916380616042 |
| Fax |
|
| Email |
drsavarinjebha4321@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tony Thomson Chandy |
| Designation |
Professor |
| Affiliation |
Christian Medical College |
| Address |
Department of Anaesthesiology ,
Christian Medical College ,
Vellore-632004
Vellore
TAMIL NADU
632004
India |
| Phone |
919500242412 |
| Fax |
|
| Email |
tonythomson@cmcvellore.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tony Thomson Chandy |
| Designation |
Professor |
| Affiliation |
Christian Medical College |
| Address |
Department of Anaesthesiology ,
Christian Medical College ,
Vellore-632004
Vellore
TAMIL NADU
632004
India |
| Phone |
919500242412 |
| Fax |
|
| Email |
tonythomson@cmcvellore.ac.in |
|
|
Source of Monetary or Material Support
|
| Fluid Research Grant, Christian Medical College, Vellore- 632004, Tamil Nadu, India. |
|
|
Primary Sponsor
|
| Name |
Dr.Savarinjebha J |
| Address |
Post Graduate Registrar,
Junior Resident in Anaesthesiology ,
Christian Medical College ,
Vellore-632004 , Tamil Nadu , India. |
| Type of Sponsor |
Other [Self] |
|
|
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 Savarinjebha J |
Christian Medical College |
General surgery operation theatre ,
Department of Anaesthesiology ,
Vellore 632004.
Vellore
TAMIL NADU |
6380616042
drsavarinjebha4321@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee ,Christian medical college, Vellore. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K639||Disease of intestine, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Laparoscopic assisted Transversus abdominus plane block |
2o ml of 0.375% Ropivacaine with dexmedetomidine 12.5mg , Transversus abdominus plane block administered via laparoscopy , monitor pain for 24 hours |
| Comparator Agent |
Ultrasound guided Rectus sheath block |
2o ml of 0.375% Ropivacaine with dexmedetomidine 12.5mg , Rectus sheath block administered via ultrasound , monitor pain for 24 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
i. Age between 18 to 60,
ii. All ASA 1 to 2 patients undergoing laparoscopic
colorectal surgery |
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Ideal body weight less than 50 kg
3. ASA >3 patient
4. Emergency surgery
5. Allergic to local anaesthetic
6. Later converted to open laparotomy
7. Divarication of rectus muscle
8. Contraindication to opoids and NSAIDS |
|
|
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 |
| Comparison of post op analgesia at rest and on movement |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Comparison of the total analgesia used in postoperative 24 hours.
2. postoperative incentive spirometry lung volumes
3. Incidence of nausea and vomiting |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 |
|
Date of First Enrollment (India)
|
25/03/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Minimally invasive surgery in colorectal surgery has become the standard of care for cancer of the large intestine. For the extraction of the resected specimen a midline incision is made. However, postoperative pain is significantly high and often requires intravenous opioid analgesia. Regional anaesthesia techniques help mitigating post-operative pain without the side effects of opioids and help in early recovery. The somatic innervation of the abdomen traverses through the tranversus abdominal plane and instillation of local anaesthetics into the plane. The ubiquitous availability of ultrasound had made the regional anaesthesia more reliable and safer, while requiring some skills to effectively administer the block. In laparoscopic surgery, administering local anaesthetics under direct vision. In colorectal surgery, the incision is made midline where the TAP block may not cover adequately. Rectus sheath block may be more effective in covering midline incision. Our study aims to compare the efficacy of LTAP (administered by surgeons) and bilateral rectus sheath block (by anaesthetists) in decreasing immediate postoperative pain and evaluation of the effects of vital capacity. |