| CTRI Number |
CTRI/2024/12/078514 [Registered on: 24/12/2024] Trial Registered Prospectively |
| Last Modified On: |
21/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Role of pudendal nerve block in pain management after anorectal surgeries. |
|
Scientific Title of Study
|
Analgesic effectiveness of pudendal nerve block for postoperative pain management in anorectal surgery- 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 |
MARNANJAL KUMAR |
| Designation |
Junior Resident |
| Affiliation |
King Georges Medical University |
| Address |
Department of Anesthesiology, King Georges Medical University, Chowk
Lucknow UTTAR PRADESH 226003 India |
| Phone |
9838655303 |
| Fax |
|
| Email |
marnanjalkv10a1@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Shefali Gautam |
| Designation |
Additional Professor |
| Affiliation |
King Georges Medical University |
| Address |
Department of Anesthesiology, King Georges Medical University, Chowk
Lucknow UTTAR PRADESH 226003 India |
| Phone |
9559468440 |
| Fax |
|
| Email |
drshefaligautam@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Shefali Gautam |
| Designation |
Additional Professor |
| Affiliation |
King Georges Medical University |
| Address |
Department of Anesthesiology, King Georges Medical University, Chowk
Lucknow UTTAR PRADESH 226003 India |
| Phone |
9559468440 |
| Fax |
|
| Email |
drshefaligautam@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology, King Georges Medical University, Chowk, Lucknow, Uttar Pradesh, India |
|
|
Primary Sponsor
|
| Name |
Marnanjal Kumar |
| Address |
Department of Anesthesiology, King Georges Medical University, Chowk, Lucknow, Uttar Pradesh, India |
| 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 MARNANJAL KUMAR |
King Georges Medical University |
Department of Anesthesiology Lucknow UTTAR PRADESH |
05222258880
info@kgmcindia.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KING GEORGES MEDICAL UNIVERSITY INSTITUTIONAL 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 |
SADDLE BLOCK |
WE WILL GIVE SADDLE BLOCK WITH BUPIVACAINE HEAVY(1.5 ML) |
| Intervention |
USG GUIDED PUDENDAL NERVE BLOCK |
WE WILL GIVE SADDLE BLOCK WITH BUPIVACAINE HEAVY(1.5 ML) AND THEN WE GIVE PUDENDAL NERVE BLOCK WITH 0.25% LEVOBUPIVACAINE 5 ML ON EACH SIDE. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient of either sex of age group 18-60 years ,ASA I,II and III posted for elective haemorrhoidectomy surgery under saddle block |
|
| ExclusionCriteria |
| Details |
Perianal suppurative lesions
Malignancy
Inflammatory bowel disease
ASA III & ASA IV
Contraindicated to regional Anesthesia.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| • To compare the postoperative pain with the help of Visual analogue score at 0,3,6,12 and 24 hrs |
0,3,6,12 and 24 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare Requirement of total rescue analgesic and Total length of hospital stay
|
Extra drugs required and length of hospital stay |
|
|
Target Sample Size
|
Total Sample Size="64" Sample Size from India="64"
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 2 |
|
Date of First Enrollment (India)
|
20/01/2025 |
| 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
|
Anorectal surgeries often result in significant postoperative pain, which can impede recovery and necessitate high doses of opioid analgesics, leading to adverse effects. Effective pain management strategies are crucial to enhance patient comfort, expedite recovery, and reduce opioid consumption. Pudendal nerve block (PNB) targets the primary nerve supplying the anorectal region, potentially offering superior pain control. Despite its theoretical advantages, there is limited clinical evidence on its efficacy and safety in this context. This study to evaluates the efficacy of pudendal nerve block (PNB) in managing postoperative pain following anorectal surgery. The research involved patients undergoing various anorectal procedures, who were randomly assigned to receive either a pudendal nerve block or a placebo. Aim of this study to assess the effectiveness of pudendal nerve block in post operative pain relief for anorectal surgeries. Primary Objective -To assess the Postoperative pain with the help of Visual analogue score at 0,3,6,12 and 24hrs. Secondary Objectives: Requirement of rescue analgesic(total dose) and Total length of hospital stay. Randomization will be done computer generated random number table all Patient will be divided in two groups. Group A : Saddle block + Pudendal nerve block – 0.25% levobupivacaine 10ml/each side. Group B : (Control group) Saddle block – 0.5% bupivacaine heavy 1.5 ml. Key findings indicated that patients who received the PNB reported significantly lower pain scores compared to the placebo group, particularly in the first 24 hours after surgery. Additionally, the PNB group required fewer opioid analgesics, demonstrating an overall reduction in postoperative opioid consumption. Secondary outcomes, including patient satisfaction and the requirement of rescue analgesic (total dose) and total length of hospital stay. The study concludes that pudendal nerve block is a valuable technique in the multimodal approach to postoperative pain management for anorectal surgeries, offering better pain relief and reducing the need for opioid medications. |