| CTRI Number |
CTRI/2025/03/081948 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
19/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between two types of local pain relief approaches for key hole gall bladder removal for postoperative pain relief |
|
Scientific Title of Study
|
Erector spinae plane block vs oblique subtotal transversus abdominis plane block for postoperative analgesia in laparascopic cholecystectomy : A prospective randomized comparative study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gayathri Santhanam |
| Designation |
Assitant Professor |
| Affiliation |
ACS Medical College and Hospital |
| Address |
Department of Anaesthesiology, ACS Medical College and Hospital, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
9790787215 |
| Fax |
|
| Email |
gayathrisansuk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gayathri Santhanam |
| Designation |
Assitant Professor |
| Affiliation |
ACS Medical College and Hospital |
| Address |
Department of Anaesthesiology, ACS Medical College and Hospital, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
9790787215 |
| Fax |
|
| Email |
gayathrisansuk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gayathri Santhanam |
| Designation |
Assitant Professor |
| Affiliation |
ACS Medical College and Hospital |
| Address |
Department of Anaesthesiology, ACS Medical College and Hospital, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
9790787215 |
| Fax |
|
| Email |
gayathrisansuk@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology
ACS Medical College and Hospital
|
|
|
Primary Sponsor
|
| Name |
Gayathri Santhanam |
| Address |
Department of Anaesthesiology, ACS Medical College and Hospital, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077
|
| 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 |
| Gayathri Santhanam |
ACS medical college and hospital |
Department of Anaesthesiology, ACS Medical College and Hospital, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077
Thiruvallur
TAMIL NADU |
9790787215
gayathrisansuk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr.M.G.R. Educational and research institute |
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 |
ERECTOR SPINAE PLANE BLOCK (ESP) |
in erector spinae plane block- between erector spinae muscle and transverse process of T9, 20 ml of 0.25% bupivacaine with 0.5mcg/kg dexmedetomidine will be injected using 50mm stimuplex needle under ultrasound guidance between the erector spinae muscle and transverse process of T9. This will be done once on both sides. Duration of intervention will be 10 minutes. |
| Comparator Agent |
OBLIQUE SUBCOSTAL TRANSVERSE ABDOMINIS PLANE BLOCK
|
in oblique subcostal transverse abdominis plane block - between the rectus and transversus abdominis muscle, 20ml of 0.25% bupivacaine with 0.5mcg/kg dexmedetomidine will be injected using 50mm stimuplex needle under ultrasound guidance between the muscle plane. This will be done once on both sides. Duration of intervention will be 10 minutes.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients with ASA physical status I-II are scheduled for laparoscopic cholecystectomy. |
|
| ExclusionCriteria |
| Details |
inability to speak,
pregnancy, alcohol or drug abuse, chronic opioid intake, consumption of any pain killers within the 24 h before the operation,
infection at injection site,
allergy to local anesthetics,
cardiac disease associated with dyspnea of New York Heart Association class more than grade 2,
severe psychiatric disorders and history of abdominal surgery or trauma,
conversion of laparoscopic to open surgery
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to compare the time for first rescue analgesic administration |
Baseline, 2nd hour, 4th hour, 6th hour, 12th hour and 24th hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the total dose of analgesic required |
2nd hour
4th hour
6th hour
12th hour
24th hour |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 4 |
|
Date of First Enrollment (India)
|
10/03/2025 |
| 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
|
A group of two with 30 patients each comparing the time for first rescue analgesic administration , the total dose of analgesic required and the severity of the postoperative pain via visual analogue score both at rest and on movement for upto 24 hours after the administration of erector spinae block and oblique subcostal transverse abdominis plane block in patients undergoing total abdominal hystrectomy. |