| CTRI Number |
CTRI/2024/08/072126 [Registered on: 08/08/2024] Trial Registered Prospectively |
| Last Modified On: |
07/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Study to see the effect of analgesia in post operative pain in perianal surgery. |
|
Scientific Title of Study
|
Peri-anal block for post-operative analgesia in peri-anal surgery under spinal anaesthesia- A prospective randomized placebo-controlled 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 |
Dr Shruti Priya |
| Designation |
Post Graduate student |
| Affiliation |
Indira Gandhi Institute of Medical Sciences |
| Address |
DEPT OF ANAESTHESIA , NEURO OT COMPLEX, 1ST FLOOR WARD
BLOCK, IGIMS, SHEIKPURA, PATNA
Patna
BIHAR
800014
India |
| Phone |
9128372429 |
| Fax |
|
| Email |
shrutipriyambbs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shruti Priya |
| Designation |
Post Graduate student |
| Affiliation |
Indira Gandhi Institute of Medical Sciences |
| Address |
DEPT OF ANAESTHESIA , NEURO OT COMPLEX, 1ST FLOOR WARD
BLOCK, IGIMS, SHEIKPURA, PATNA
Patna
BIHAR
800014
India |
| Phone |
9128372429 |
| Fax |
|
| Email |
shrutipriyambbs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr NIDHI ARUN |
| Designation |
Associate professor |
| Affiliation |
Indira Gandhi Institute of Medical Sciences |
| Address |
DEPT OF ANAESTHESIA , NEURO OT COMPLEX, 1ST FLOOR WARD
BLOCK, IGIMS, SHEIKPURA, PATNA
Patna
BIHAR
800014
India |
| Phone |
9523594059 |
| Fax |
|
| Email |
janya.mukesh@yahoo.com |
|
|
Source of Monetary or Material Support
|
| DEPT OF ANAESTHESIA,NEURO OT COMPLEX,1ST FLOOR WARD BLOCK,IGIMS,SHEIKPURA,PATNA,BIHAR 800014,INDIA. |
|
|
Primary Sponsor
|
| Name |
Dr Shruti Priya |
| Address |
DEPT OF ANAESTHESIA , NEURO OT COMPLEX, 1ST FLOOR WARD BLOCK, IGIMS, SHEIKPURA, PATNA. |
| 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 Shruti Priya |
Indira gandhi institute of medical Scieces, Patna. |
DEPT OF ANAESTHESIA , NEURO OT COMPLEX, 1ST FLOOR WARD BLOCK, IGIMS, SHEIKPURA, PATNA, BIHAR.
Patna
BIHAR |
9128372429
shrutipriyambbs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES, PATNA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L988||Other specified disorders of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.25% bupivacaine with dexmedetomidine |
Comparator agent will be compared with 0.9% NS. Control group will receive perianal block with 40ml of o.9% of NS and other group will receive peri-anal block with study drug (40 ml of 0.25% bupivacaine with 0.5 micro gm/kg dexmedetomidine). |
| Intervention |
Peri-anal block |
20G needle will be introduced into ischiorectal fossa on both sides 2-3 cm lateral to the anal verge, directed 45º anterior and 45º laterally then 10 ml solution will be injected. Needle will be partially withdrawn and re-directed posterior and lateral at the same angle then 10ml of study solution will be injected. Same procedure was repeated on the other side. Each quadrant will receive 10ml solution, thus 40ml in total |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
78.00 Year(s) |
| Gender |
Both |
| Details |
1. Posted for electric peri-anal surgeries like fistula-in-ano, fissure, pilonidal sinus.
2. Surgery under spinal anaesthesia. |
|
| ExclusionCriteria |
| Details |
1. Patient refusal.
2. Allergy to study drugs.
3. Pregnancy.
4. Acute peri-anal abscess and anorectal cancer.
5. Failed spinal block.
6. Inability to understand patient information leaflet and NRS score |
|
|
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 |
| To compare time of first analgesia requirement in minutes when NRS greater than 4 |
In postoperative at interval of just after surgery-1hr-2hr-4hr-8hr. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare total dose of analgesic requirement in term of morphine equivalent
2. To compare patient satisfaction score after surgery.
3. To compare the incidence of side effect |
1. In 1st 24hrs postoperative.
2. In 1st 24hrs postoperative.
3. In 1st 24hrs postoperative. |
|
|
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)
|
25/08/2024 |
| 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="6"
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
|
Patient
discomfort is exacerbated by postoperative pain, which increases the length of
time spent in the ambulatory care unit. Post-operative pain management may be assisted by
non-pharmacological therapies during the perioperative period. The
pudendal nerve innervates the urethral muscles, clitoris, penis, and
perineum.
Thus, we hypothesise that
post-operative peri-anal block with 40 ml of 0.25% bupivacaine and
dexmedetomidine (0.5 mg/kg) will provide effective and prolonged post-operative
analgesia. |