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CTRI Number  CTRI/2017/02/007955 [Registered on: 23/02/2017] Trial Registered Prospectively
Last Modified On: 14/12/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A clinical study to understand the pain relieving effects of drug dexmedetomidine in patients who have undergone below knee trauma surgery  
Scientific Title of Study   Role of dexmedetomidine as adjuvant in postoperative sciatic popliteal and adductor canal analgesia in trauma patients 
Trial Acronym  none 
Secondary IDs if Any  
Secondary ID  Identifier 
None   NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vanita Ahuja  
Designation  Associate Professor  
Affiliation  Government Medical College and Hospital  
Address  Department of Anaesthesia and Intensive care level V, D Block Government Medical College and Hospital sector 32

Chandigarh
CHANDIGARH
160030
India 
Phone  09646121649  
Fax    
Email  vanitaanupam@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Anjuman 
Designation  Postgraduate resident  
Affiliation  Government Medical College and Hospital  
Address  Department of Anaesthesia and Intensive care Level V, Block D Government Medical College and Hospital sector 32

Chandigarh
CHANDIGARH
160030
India 
Phone  09888443570  
Fax    
Email  jchander@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Vanita Ahuja  
Designation  Associate Professor  
Affiliation  Government Medical College and Hospital  
Address  Department of Anaesthesia and Intensive care Level V, Block D Government Medical College and Hospital sector 32

Chandigarh
CHANDIGARH
160030
India 
Phone  09646121649  
Fax    
Email  vanitaanupam@yahoo.co.in  
 
Source of Monetary or Material Support  
Level V, Block D Department of Anaesthesia and Intensive Care Government Medical College Hospital Chandigarh  
 
Primary Sponsor  
Name  Government Medical College Hospital Chandigarh 
Address  Department of Anaesthesia and Intensive Care Government Medical College Hospital Chandigarh  
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
None  None 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vanita Ahuja  Government Medical College Hospital Chandigarh  Level V Block D Department of Anaesthesia and Intensive care Government Medical College Hospital Chandigarh
Chandigarh
CHANDIGARH 		 09646121649

vanitaanupam@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee GMCH Chandigarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Group I Adductor canal block with 16 ml of a solution having 15 ml 0.5 % ropivacaine with 1 ml normal saline Sciatic popliteal block 21 ml solution with 20 ml 0.15 % ropivacaine with 1 ml normal saline and 10 ml intravenous normal saline   Adductor canal block with 16 ml of a solution having 15 ml 0.5 % ropivacaine with 1 ml normal saline Sciatic popliteal block 21 ml solution with 20 ml 0.15 % ropivacaine with 1 ml normal saline and 10 ml intravenous normal saline Postoperatively every six hours bolus of 15 ml only 0.5 % ropivacaine in ACB and 20 ml only 0.15 % ropivacaine in SPB 12 hourly for 48 hours Plus Intravenous Tramadol PCA for 48 hours  
Intervention  Group II Adductor canal block with 16 ml of a solution having 15 ml 0.5 % ropivacaine and perineurial dexmedetomidine 0.5 microgram per kg constituted in 1 ml normal saline Sciatic popliteal block 21 ml solution with 20 ml 0.15 % ropivacaine and perineurial dexmedetomidine 0.5 microgram per kg constituted in 1 ml normal saline and 10 ml intravenous normal saline  Adductor canal block with 16 ml of a solution having 15 ml 0.5 % ropivacaine and perineurial dexmedetomidine 0.5 microgram per kg constituted in 1 ml normal saline Sciatic popliteal block 21 ml solution with 20 ml 0.15 % ropivacaine and perineurial dexmedetomidine 0.5 microgram per kg constituted in 1 ml normal saline and 10 ml intravenous normal saline Postoperatively every six hours bolus of 15 ml only 0.5 % ropivacaine in ACB and 20 ml only 0.15 % ropivacaine in SPB 12 hourly for 48 hours Plus Intravenous Tramadol PCA for 48 hours  
Comparator Agent  Group III Adductor canal block with 16 ml of a solution having 15 ml 0.5 % ropivacaine and 1 ml normal saline Sciatic popliteal block 21 ml solution with 20 ml 0.15 % ropivacaine and 1 ml normal saline and intravenous dexmedetomidine 1 microgram per kg constituted in 10 ml normal saline   Adductor canal block with 16 ml of a solution having 15 ml 0.5 % ropivacaine and 1 ml normal saline Sciatic popliteal block 21 ml solution with 20 ml 0.15% ropivacaine and 1 ml normal saline and intravenous dexmedetomidine 1 microgram per kg in 10 ml normal saline Postoperatively every six hours bolus of 15 ml 0.5 % ropivacaine in ACB and 20 ml 0.15% ropivacaine in SPB 12 hourly for 48 hours Plus Intravenous Tramadol PCA for 48 hours  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details 
1.ASA physical status I and II of both sex.
2.Age between 18 to 65 years.
3. BMI ≥ 20 to ≤ 35 kg m-2 .
4.Scheduled for below knee surgery following acute trauma 
 
ExclusionCriteria 
Details 
1.Patients having history of substance abuse.
2.Patients with coagulopathy and bleeding disorders.
3.Preexisting peripheral neuropathy.
4.Preexisting local infection at the site of block.
5.Pregnant and lactating women.
6.Inability to understand functioning of PCA pump and VAS (Visual Analogue Scale).
7.Contraindication or allergy to study drug ropivacaine, dexmedetomidine and tramadol.
8.Patients having haemodynamic instability.
9.Patients on regular chronic pain management drugs for the last three months.
10.Patients with history of head injury and/or polytrauma 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To study tramadol-sparing effect of dexmedetomidine as an adjuvant to ropivacaine in ultrasound guided adductor canal block (ACB) and sciatic popliteal block (SPB) following surgery in below knee surgery   At regular interval upto one hour and then
4 hour
6 hour
12 hour
18 hour
24 hour
30 hour
36 hour
42 hour
48 hour 
 
Secondary Outcome  
Outcome  TimePoints 
To study the hemodynamics,
Visual analogue score at rest and on movement
Ramsay Sedation Score
Quadriceps strength test
planter and dorsiflexion
sensory analgesia
rescue analgesia
adverse effects
and patient satisfaction score in patients receiving PNB following below knee surgeries 		 At regular interval upto one hour and then
4 hour
6 hour
12 hour
18 hour
24 hour
30 hour
36 hour
42 hour
48 hour 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="90" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   01/03/2017 
Date of Study Completion (India) 15/05/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Brief Summary

 

 The present study will be conducted in the Department of Anaesthesia and Intensive Care, Government Medical College and Hospital, Chandigarh in collaboration with the department of Orthopaedics, Government Medical College and Hospital, Chandigarh. After approval from the Hospital Ethics Committee and registration with Clinical Trial Registry India, 90 patients of American society of Anesthesiologists (ASA) physical status I &II of either sex, aged between trauma will be enrolled.

Study design- Prospective, randomized, double blind and placebo controlled trial. 

 

The primary outcome measures will be to study tramadol sparing effect  in patients receiving dexmedetomidine as adjuvant in adductor canal and sciatic popliteal nerve block  in patients undergoing below knee trauma surgeries.

The secondary outcomes will be to study the hemodynamics, VAS at rest and on movement, Ramsay Sedation scale  Quadriceps muscle strength, rescue analgesia  adverse effects patient satisfaction score, length of hospital stay and follow up at three months (telephonically)  in patients receiving adductor canal block and sciatic popliteal nerve block following below knee surgeries.

Sample size was calculated on the basis of pilot cases conducted in the department of Anaesthesia and Intensive Care, Government Medical College and Hospital, Chandigarh. It was observed that the mean tramadol consumption in the patients receiving ropivacaine in the ACB and SPB (control group) was 106.60 mg with a standard deviation of 37.40 mg. Considering a difference of 30 % in tramadol consumption in study group as compared to control group as statistically significant, with an effective size of 0.34, the required sample size came out to be 27 patients per group at a power of 80%. To compensate for dropouts, we decided to include 30 patients per group. So, the total sample size of our study will be 90 patients. 

 

 
 
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