| CTRI Number |
CTRI/2022/05/042764 [Registered on: 24/05/2022] Trial Registered Prospectively |
| Last Modified On: |
19/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Post operative pain management in laparoscopic surgeries |
|
Scientific Title of Study
|
Comparison of ultrasound guided
subcostal transverse abdominis plane
block using dexamethasone and
clonidine as adjuvants with ropivacaine
for postoperative analgesia in laparoscopic surgeries: A prospective randomized double blind study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Akshatha B |
| Designation |
Post graduate student |
| Affiliation |
SDM medical college and hospital |
| Address |
Dept of Anaesthesiology
SDM medical college and hospital
Sattur
Dharwad
Dharwad
KARNATAKA
580009
India |
| Phone |
7829838338 |
| Fax |
|
| Email |
akshathab18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pavan Dhulkhed |
| Designation |
Associate professor |
| Affiliation |
SDM medical college |
| Address |
Dept of Anaesthesiology
SDM medical college
Dharwad
580009
Dharwad
KARNATAKA
580009
India |
| Phone |
8150885678 |
| Fax |
|
| Email |
pavandhulkhed1984@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pavan Dhulkhed |
| Designation |
Associate professor |
| Affiliation |
SDM medical college |
| Address |
Dept of Anaesthesiology
SDM medical college
Dharwad
580009
Chikmagalur
KARNATAKA
580009
India |
| Phone |
8150885678 |
| Fax |
|
| Email |
pavandhulkhed1984@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDMCMSH
Manjushree nagar
Sattur
Dharwad |
|
|
Primary Sponsor
|
| Name |
SDMCMSH |
| Address |
Dept of Anaesthesiology
SDM medical college and hospital
Sattur, Dharwad |
| Type of Sponsor |
Research institution |
|
|
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 Akshatha B |
SDM medical college |
Dept of Anaesthesiology
2nd floor
SDM medical college
Sattur
Dharwad
Dharwad
KARNATAKA |
7829838338
akshathab18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDM INSTITUTION 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 |
| Comparator Agent |
Clonidine |
Group C: Patients in this group will receive TAP block on each side with 0.375% ropivacaine 20 ml along with 1mcg/kg of clonidine made to 1ml. |
| Intervention |
Clonidine as adjuvants with ropivacaine in subcostal tap block for postoperative analgesia |
Group C: Patients in this group will receive TAP block on each side with 0.375% ropivacaine 20 ml along with 1mcg/kg of clonidine made to 1ml. |
| Comparator Agent |
Dexamethasone |
Group D: Patients in this group will receive TAP block on each side with 0.375% ropivacaine 20 ml along with 1ml (4mg) of dexamethasone as additive. |
| Intervention |
Dexamethasone as adjuvant with ropivacaine in subcostal tap block for post operative analgesia |
Group D: Patients in this group will receive TAP block on each side with 0.375% ropivacaine 20 ml along with 1ml (4mg) of dexamethasone as additive.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elective laparoscopic abdominal surgeries of duration 60-120 mins
ASA Physical status 1,2
Those who willing to participate |
|
| ExclusionCriteria |
| Details |
1. Patient refusal.
2. Patients with ASA III and IV.
3. Patients with BMI < 18 kg/m2 and > 35 kg/m2.
4. Local infection at the site of block.
5. Allergy to study medications.
6.Chronic use of pain medications. |
|
|
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 compare the duration of analgesic effect by addition of dexamethasone and clonidine with ropivacaine in sub costal TAP block
2. To determine VAS scores in first 24 h. |
24 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess incidence of nausea or vomiting or other side effects, if any. |
24 hrs |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
25/05/2022 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Regional anaesthesia is one of popular methods and has become integral part of both intraoperative anaesthesia and post-operative analgesia. Wide variety of blocks is being practiced, which avoids polypharmacy, reduces hospital stay and provide good post-operative recovery to the patients.
One such modality which aims at smooth post-op recovery in laparoscopic surgeries is subcostal transverse abdominis plane (TAP) block. The better outcome of the subcostal TAP block is due to accurate localization of transverse abdominis plane by ultrasound guidance and prolongation of duration of action with help of adjuvants like fentanyl, dexamethasone, clonidine etc. to local anaesthetics.
This study aims to compare the effect of drugs dexamethasone and clonidine as adjuvant to ropivacaine in subcostal TAP block to decrease post-operative pain and to ease the recovery in patients undergoing laparoscopic abdominal surgeries
In this study patients will be randomly allocated in two groups and recieve TAP block at the end of surgery Group D: Patients in this group will receive TAP block on each side with 0.375% ropivacaine 20 ml along with 1ml (4mg) of dexamethasone as additive Group C: Patients in this group will receive TAP block on each side with 0.375% ropivacaine 20 ml along with 1mcg/kg of clonidine made to 1ml.
Postoperatively we assess the duration of analgesic effect by addition of dexamethasone and clonidine with ropivacaine in sub costal TAP block. To determine VAS scores in first 24 h. Secondary, Objectives:- 1. To assess incidence of nausea or vomiting or other side effects, if any.
The time at which rescue analgesia administered will be noted. Side effects like bradycardia, hypotension will be monitored and treated as per standard care.
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