| CTRI Number |
CTRI/2025/05/086169 [Registered on: 02/05/2025] Trial Registered Prospectively |
| Last Modified On: |
02/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Butorphanol as an adjuvant to Ropivacaine for post operative pain management in knee arthroscopic surgery , a prospective randomised interventional study |
|
Scientific Title of Study
|
Comparison of different doses of Butorphanol as adjuvant with Ropivacaine for single shot Adductor canal block in knee Arthroscopic surgery |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohit Kandari |
| Designation |
Postgraduate resident |
| Affiliation |
Himalayan Institute of Medical Sciences, SRHU Dehradun |
| Address |
Department of anaesthesiology , Himalayan institute of medical sciences , Swami Rama Himalayan University
Dehradun UTTARANCHAL 248140 India |
| Phone |
9557923345 |
| Fax |
|
| Email |
mkandari1611@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Nidhi Kumar |
| Designation |
Professor |
| Affiliation |
Himalayan Institute of Medical Sciences, SRHU Dehradun |
| Address |
Department of anaesthesiology , Himalayan institute of medical sciences , Swami Rama Himalayan University
Dehradun UTTARANCHAL 248140 India |
| Phone |
9458977411 |
| Fax |
|
| Email |
nidhikumar@srhu.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Mohit Kandari |
| Designation |
Postgraduate resident |
| Affiliation |
Himalayan Institute of Medical Sciences, SRHU Dehradun |
| Address |
Department of anaesthesiology , Himalayan institute of medical sciences , Swami Rama Himalayan University
Dehradun UTTARANCHAL 248140 India |
| Phone |
9557923345 |
| Fax |
|
| Email |
mkandari1611@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology , Himalayan institute of medical sciences , Swami Rama Himalayan University , Dehradun |
|
|
Primary Sponsor
|
| Name |
Swami Rama Himalayan University |
| Address |
Department of anaesthesiology , Himalayan institute of medical sciences , Swami Rama Himalayan University, Dehradun |
| 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 |
| Mohit Kandari |
Himalayan institute of medical sciences , Swami Rama Himalayan University |
Department of anaesthesiology , Himalayan institute of medical sciences , Swami Rama Himalayan University Dehradun UTTARANCHAL |
9557923345
mkandari1611@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, SRHU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M238||Other internal derangements of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Addition of butorphanol |
The other two groups , group R1 will be having ropivacaine 0.2%,19ml with 1mg/ml of butorphanol and group R2 will be having ropivacaine0.2%, 19ml with 2mg/ml of butorphanol which will be given post operatively |
| Comparator Agent |
No adjuvant addition , control group |
This group R3 will have plain ropivacaine 0.2% ,19ml with 1ml of saline |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1- patient aged 18 to 60 years
2- ASA Grade 1 and 2
3- consent for regional anaesthesia |
|
| ExclusionCriteria |
| Details |
1-ASA III and IV
2-Refusal or contraindication for regional anaesthesia
3-Known allergy to local anaesthesia
4-Bleeding disorder
5-Patient on anticoagulant medications
6-Infection at local site
7-Significant cardiac disease, renal failure, Asthma
8-Patient with psychiatric disorder or inability to operate PCA pump
9- Body mass index more than 30 kilogram per metre square of height
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of duration of analgesia detected by the first analgesia rescue dose and total analgesic consumption |
first analgesia rescue dose and total analgesic consumption |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The impact of single shot adductor canal blovk using ropivacaine and butorphanol on postoperative recovery |
Patient outcome assessment , sedation , and the side effects that could occur in yhr 24 hour study period in patients undertaking tptal knee arhtroscopu |
|
|
Target Sample Size
|
Total Sample Size="75" Sample Size from India="75"
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 4 |
|
Date of First Enrollment (India)
|
02/06/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
02/06/2025 |
| 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 Yet Recruiting |
| 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
|
AIMS AND OBJECTIVES 1- To evaluate the post operative analgesic efficacy of two different doses of butorphanol using NRS pain scoring system in USG guided adductor canal block in knee arthroscopic surgery . 2- To compare total post operative analgesic consumption among the three groups. 3- To compare the incidence of adverse effects and complications if any. 4-To evaluate patient satisfaction using QR15 score .
BRIEF SUMMARY Arthroscopy (also called arthroscopic or keyhole surgery) is a minimally invasive surgical procedure on a joint in which an examination and treatment of damage is performed using an arthroscope, an endoscope that is inserted into the joint through a small incision. Arthroscopic procedures can be performed during ACL reconstruction. This reduces recovery time and may increase the rate of success due to less trauma to the connective tissue. It has gained popularity due to evidence of faster recovery times with less scarring, because of the smaller incisions.
Arthroscopic knee surgery is accompanied with considerable postoperative pain. Early postoperative mobilization and rehabilitation require adequate pain management of the patient . Despite the fact that femoral nerve block (FNB) or continuous epidural anesthesia (CEA) can provide adequate postoperative pain control, both treatments have negative side effects such as muscle weakness, delayed recovery which can delay postoperative mobilization . The adductor canal block (ACB) is a relatively newer analgesic block for knee arthroscopic surgery that not only blocks the femoral nerve’s largest sensory branch, but also causes a smaller decrease in quadriceps muscle strength in adult patients than the femoral nerve block (FNB)
ACB provides analgesia equivalent to FNB ,also preserves quadriceps muscular strength better than FNB, and so allows for functional recovery within the first day after arthroscopic knee surgery according to randomized controlled trials. The primary outcome is the assessment of duration of analgesia detected by the first analgesia rescue dose and total analgesic consumption. Secondary outcomes includes the impact of single-shot adductor canal block using ropivacaine and butorphanol on postoperative recovery by patient outcome assessment , sedation, and the side effects that could occur in the 24-hour study period in patients undertaking total knee arthroscopy.
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