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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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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