| CTRI Number |
CTRI/2021/10/037085 [Registered on: 05/10/2021] Trial Registered Prospectively |
| Last Modified On: |
21/02/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative study of efficacy of Ultrasound guided Pudendal nerve block with Spinal Anaesthesia in ambulatory anorectal surgeries |
|
Scientific Title of Study
|
Comparison of efficacy of Ultrasound guided Pudendal nerve block with Spinal Anaesthesia in ambulatory anorectal surgery : A prospective Randomized 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 Anusha Suntan |
| Designation |
Assistant Professor |
| Affiliation |
BLDE Deemed to be Shri B. M. Patil medical college & research centre |
| Address |
Department of Anaesthesiology, 3rd floor OT complex,
BLDE Deemed to be Shri B. M. Patil medical college and research centre , Vijayapur
Department of Anaesthesiology, 3rd floor OT complex,
BLDE Deemed to be Shri B. M. Patil medical college and research centre , Vijayapur
Bijapur
KARNATAKA
586103
India |
| Phone |
7795324301 |
| Fax |
|
| Email |
dranushasuntan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anusha Suntan |
| Designation |
Assistant Professor |
| Affiliation |
BLDE Deemed to be Shri B. M. Patil medical college & research centre |
| Address |
Department of Anaesthesiology, 3rd floor OT complex,
BLDE Deemed to be Shri B. M. Patil medical college and research centre , Vijayapur
Department of Anaesthesiology, 3rd floor OT complex,
BLDE Deemed to be Shri B. M. Patil medical college and research centre , Vijayapur
Bijapur
KARNATAKA
586103
India |
| Phone |
7795324301 |
| Fax |
|
| Email |
dranushasuntan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anusha Suntan |
| Designation |
Assistant Professor |
| Affiliation |
BLDE Deemed to be Shri B. M. Patil medical college & research centre |
| Address |
Department of Anaesthesiology, 3rd floor OT complex,
BLDE Deemed to be Shri B. M. Patil medical college and research centre , Vijayapur
Department of Anaesthesiology, 3rd floor OT complex,
BLDE Deemed to be Shri B. M. Patil medical college and research centre , Vijayapur
Bijapur
KARNATAKA
586103
India |
| Phone |
7795324301 |
| Fax |
|
| Email |
dranushasuntan@gmail.com |
|
|
Source of Monetary or Material Support
|
| BLDE Deemed to be Shri B. M. Patil medical college and research centre |
|
|
Primary Sponsor
|
| Name |
BLDE Deemed to be Shri B M Patil medical college and research centre |
| Address |
Vijayapur |
| 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 |
| Anusha Suntan |
BLDE Deemed to be Shri B. M. Patil medical college and research centre |
Department of Anaesthesiology, 3rd floor OT complex,
BLDE Deemed to be Shri B. M. Patil medical college and research centre , Vijayapur
Bijapur
KARNATAKA |
7795324301
dranushasuntan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BLDE Deemed to be Shri B. M. Patil medical college, hospital & research centre vijayapur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I879||Disorder of vein, unspecified, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Spinal Anaesthesia |
The second group will be given spinal anaesthesia as per randomization with Bupivacaine 0.5(H) 2ml in sitting position. The duration of post operative analgesia will be compared with other group. |
| Intervention |
Ultrasound guided Pudendal nerve block |
Under USG guided Pudendal nerve block will be given for patients undergoing minor anorectal surgeries (Haemorrhoids, Fistula in ano , Fissure in ano).
Post operative analgesia is expected to be around 8-10 hours according to reference studies. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) ASA physical status 1 or 2
2) Age 20-60years of either sex
3) Weight upto 70kgs
4) Minor anorectal surgery procedures like Haemorrhoids, fissure in ano, fistula in ano
|
|
| ExclusionCriteria |
| Details |
1) ASA physical status 3 or 4
2) Patients with pre existing neurological or Spinal diseases, neuromuscular disorders, endocrine disorders, cardio respiratory or other systemic diseases
3)Bleeding diathesis
4) Infection at the site of block
5) known allergy to the local anaesthetics |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prolonged post operative duration of analgesia in Pudendal nerve block |
Post operative pain assessed on Visual Analog Scale (1-10) at 4, 8, 16 and 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Helps in reducing postoperative duration of stay in hospital |
Due to prolonged duration of analgesia and early mobilization, patient can be discharged on the same day of surgery (less than 24hrs stay in hospital) |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
08/10/2021 |
| Date of Study Completion (India) |
08/12/2022 |
| 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)
|
High acceptance of publication in standard journals |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The study is undertaken to compare relative merits and demerits of Pudendal nerve block with Spinal Anaesthesia in minor anorectal surgeries |