| CTRI Number |
CTRI/2024/10/075042 [Registered on: 10/10/2024] Trial Registered Prospectively |
| Last Modified On: |
06/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison between am injection given in the lower limb and a drug given with spinal anaesthesia for managing pain after arthroscopic Knee Surgeries |
|
Scientific Title of Study
|
A comparative study to evaluate the post-operative analgesic effect of IPACK Block and Intrathecal Buprenorphine in patients undergoing Arthroscopic Knee Surgeries under Spinal Anaesthesia |
| 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 Subham Tripathy |
| Designation |
Junior Resident |
| Affiliation |
MS Ramaiah Medical College |
| Address |
Department of Anaesthesiology, M S Ramaiah Medical College,
MSRIT Post, New BEL road, Bangalore 560054
Bangalore
KARNATAKA
560049
India |
| Phone |
8884122205 |
| Fax |
|
| Email |
subham0tripathy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Archana S |
| Designation |
Associate Professor |
| Affiliation |
MS Ramaiah Medical College |
| Address |
Department of Anaesthesiology, M S Ramaiah Medical College, MSRIT Post, New BEL road, Bangalore 560054
Bangalore
KARNATAKA
560054
India |
| Phone |
9845121444 |
| Fax |
|
| Email |
archvinddoc@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Archana S |
| Designation |
Associate Professor |
| Affiliation |
MS Ramaiah Medical College |
| Address |
Department of Anaesthesiology, M S Ramaiah Medical College, MSRIT Post, New BEL road, Bangalore 560054
Bangalore
KARNATAKA
560054
India |
| Phone |
9845121444 |
| Fax |
|
| Email |
archvinddoc@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| M S Ramaiah Medical College,
MSRIT Post, New BEL road, Bangalore, Karnataka, India 560054 |
|
|
Primary Sponsor
|
| Name |
MS Ramaiah Medical College |
| Address |
MS Ramaiah Medical College MSRIT Post New BEL road Bangalore 560064 |
| 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 |
| Dr Archana S |
MS Ramaiah Medical College Hospital |
Operation Theatre, 2nd Floor, MS Ramaiah Medical College MSRIT Post New BEL road Bangalore 560064
Bangalore
KARNATAKA |
9845121444
archvinddoc@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ramaiah Medical College 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 |
Spinal Anaesthesia with Intrathecal Buprenorphine |
Patients in Group 1 (56 patients) will receive sub-arachnoid block with 0.5% Hyperbaric Bupivacaine 3ml and Buprenorphine 90 mcg |
| Intervention |
Spinal Anaesthesia with IPACK Block |
Patients in Group 2 (56 patients) will receive sub-arachnoid block with 0.5% Hyperbaric Bupivacaine 3ml with IPACK block using 20ml of 0.25% plain Isobaric Bupivacaine |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All patients undergoing Arthroscopic Knee Surgeries under Spinal Anaesthesia, aged between 25 and 60 years, who fit into American Society of Anaesthesiologists (ASA I and II), with Body mass index (BMI) of less than 30 kg/m2
|
|
| ExclusionCriteria |
| Details |
Allergy to local anaesthetics,
Local infection in the knee joint,
Contraindications to Spinal anaesthesia such as coagulopathy and tight tricuspid or mitral stenosis
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time for the first rescue analgesia administered |
Time since intra-thecal injection till first rescue analgesia administered |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post-operative VAS Score |
VAS score at 2, 4, 6, 12 and 24 hrs postoperatively |
| Total rescue analgesia |
Total rescue analgesics administered in the first 24 hrs post-operatively |
|
|
Target Sample Size
|
Total Sample Size="112"
Sample Size from India="112"
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)
|
20/10/2024 |
| 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="2"
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
|
Pain in the immediate postoperative period after knee surgeries may hinder rehabilitative programmes and cause various pathophysiological consequences. Arthroscopic knee surgery is associated with variable amount of postoperative pain, which is caused by the irritation of the free nerve endings of the synovial tissue, anterior fat pad and joint capsule during surgical excision and resection. Several analgesic strategies such as systemic drugs, central or peripheral nerve blocks and intra-articular drug administration have been used to treat post-operative pain. Peripheral nerve blocks are ideally suited for lower limb surgeries because of the peripheral location of the surgical sites and potential to block pain pathways at multiple levels. The recent technique of ultrasound guided local anaesthetic infiltration of the interspace between popliteal artery and the capsule of the posterior knee (IPACK) has shown promising results. The technique involves a very selective block of the terminal sensory branches of the posterior aspect of the knee without involvement of motor branches of the tibial nerves and peroneal nerves leading to reduced pain without motor weakness. Hence, preserving the sensory motor function of the leg and foot. This leads to earlier ambulation, rehabilitation and recovery in various knee surgeries. In this study we aim to evaluate the postoperative analgesic effect of IPACK block vs Intrathecal Buprenorphine in patients undergoing arthroscopic surgeries under spinal anaesthesia. We hypothesize that IPACK block with spinal anaesthesia provides longer and better analgesia in the post-operative period, compared to Buprenorphine based spinal anaesthesia. |