| CTRI Number |
CTRI/2018/12/016807 [Registered on: 31/12/2018] Trial Registered Prospectively |
| Last Modified On: |
02/04/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A clinical trial of comparing the effects of drugs namely Dexmedetomidine and Fentanyl when added to local anaesthetic solution used in injection around wound in in surgeries around anal canal in reducing pain after surgery |
|
Scientific Title of Study
|
Comparison of analgesic efficacy of bupivacaine, bupivacaine and dexmedetomidine, and bupivacaine and Fentanyl in would infiltration technique in perianal surgeries: A prospective, randomized controlled study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gopalakrishnan K MD |
| Designation |
Assistant Professor |
| Affiliation |
Aarupadai Veedu Medical College and Hospital |
| Address |
Department of Anaesthesiology, Aarupadai Veedu Medical College and Hospital,Kirumampakkam,Pondicherry.
5,6 MAC avenue, Nellikuppam main road, Cuddalore District, Tamil
Nadu 607 001
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9364450310 |
| Fax |
|
| Email |
gopalakrishnan.kuppusamy@avmc.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Haribabu V MD |
| Designation |
Associate Professor |
| Affiliation |
Aarupadai Veedu Medical College and Hospital |
| Address |
Department of Anaesthesiology, Aarupadai Veedu Medical College and Hospital,Kirumampakkam,Pondicherry.
Department of anaesthesiology, Aarupadai Veedu Medical College and Hospital,Kirumampakkam,Pondicherry.
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9442369647 |
| Fax |
|
| Email |
saravanaharibabu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Haribabu V MD |
| Designation |
Associate Professor |
| Affiliation |
Aarupadai Veedu Medical College and Hospital |
| Address |
Department of anaesthesiology, Aarupadai Veedu Medical College and Hospital,Kirumampakkam,Pondicherry.
Department of anaesthesiology, Aarupadai Veedu Medical College and Hospital,Kirumampakkam, Pondicherry.
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9442369647 |
| Fax |
|
| Email |
saravanaharibabu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aarupadai Veedu Medical College and Hospital, Kirumampakkam, Pondicherrry 607402 |
|
|
Primary Sponsor
|
| Name |
GOPALAKRISHNAN K |
| Address |
ASSISTANT PROFESSOR, Department of anaesthesiology, Aarupadai Veedu medical college and Hospital, Puducherry |
| 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 |
| Gopalakrishnan K |
Aarupadai Veedu Medical College and Hospital, Puducherry |
Aarupadai Veedu medical college and hospital,Kirumampakkam, Puducherry 607402
Pondicherry
PONDICHERRY |
9364450310
drkgpal73@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Human Ethical Committee, AARUPADAI VEEDU MEDICAL COLLEGE &HOSPITAL |
Approved |
| Institutional Research Committee, Aarupadai Veedu Medical College & Hospital, Puducherry |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K602||Anal fissure, unspecified, (2) ICD-10 Condition: K603||Anal fistula, (3) ICD-10 Condition: K649||Unspecified hemorrhoids, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dexmedetomidine and Fentanyl |
In Group A dexmedetomidine 1.5micg/kg will be added to the local anaesthetic solution of 15ml 0.5% bupivacaine. In Group B, Fentanyl 2micg/ml will be added to the local anaesthetic solution 15ml of 0.5% bupivacaine heavy. In Group C, 1ml saline will be added to the local anaesthetic solution 15 ml of 0.5% bupivacaine. |
| Intervention |
Wound infiltration with local anaesthetic agent bupivacaine and addition of drugs Dexmedetomidine and Fentanyl to the local anaesthetic solution |
Wound infiltration with 15ml 0.5% bupivacaine will be done only once at the end of surgery. Dexmedetomidine 1.5micg/kg , Fentanyl 2micg/ml and 1ml saline will be added to the bupivacaine solution in Group A, Group B and Group C respectively. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing uncomplicated perianal surgeries like haemorrhoidectomy, fissure in ano and fistula in ano, ASA I & II, Normal BMI |
|
| ExclusionCriteria |
| Details |
ASA III and above, Obese, underweight subjects(BMI) , pregnant women, patients with bleeding and clotting disorders, allergic to local anesthetic agents,inadequate spinal blockade supplemented by other drugs and complicated surgeries will be excluded from the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Dexmedetomidine prolongs the postoperative analgesia of wound infiltration with bupivacaine and is superior to addition of fentanyl to local local would infiltration with |
12hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Total analgesics requirement in 24 hrs is reduced when dexmedetomidine is added to local anaesthetic solution. Addition of Fentanyl to local anaesthetic solution also reduces total analgesic requirement |
24hrs |
| pain perception at daefacation on next day is less intense. |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="75" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2019 |
| Date of Study Completion (India) |
28/10/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
V Haribabu, K Gopalakrishnan, M Suresh Rajkumar, V Ezhil Rajan, R Chandrasekar. Comparison of analgesic
efficacy of bupivacaine, bupivacaine with dexmedetomidine, and bupivacaine with fentanyl in local perianal infiltration technique in
perianal surgeries: A prospective, randomized controlled study. MedPulse International Journal of Anesthesiology. July 2020; 15(1):
07-14 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is a randomized, double blind, parallel group, controlled, multiarm trial comparing the efficacy of dexmedetomidine 1.5micg/kg and fentanyl 2micg/ml when added to the local aneasthetic solution used for would infiltration done at the end of surgery in patients undergoing uncomplicated perianal surgeries to be conducted at Aarupadai Veedu medical college and Hospital, Pondicherry. The primary outcome measures will be prolonging the postoperative analgesia duration when compared to control group. The secondary outcome measures will be reduction in total number of analgesics received over first 24 hrs and better defaecation score on the next day. Dexmedetomidine provides superior analgesia than Fentanyl. |