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CTRI Number  CTRI/2019/02/017660 [Registered on: 14/02/2019] Trial Registered Prospectively
Last Modified On: 24/02/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Role of pregabalin versus duloxetine on pain requirement after lower limb surgery for trauma patients 
Scientific Title of Study   Effect of pregabalin versus duloxetine on analgesic requirement following lower limb trauma surgeries: a randomized, clinical trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vanita Ahuja 
Designation  Associate Professor 
Affiliation  Government Medical College and Hospital 
Address  Department of anaesthesia and intensive care Government Medical College and Hospital

Chandigarh
CHANDIGARH
160030
India 
Phone  9646121649  
Fax    
Email  vanitaanupam@gnail.com  
 
Details of Contact Person
Scientific Query
 
Name  Alisha Chachra 
Designation  PGJR 
Affiliation  Government Medical College and Hospital 
Address  Department of anaesthesia and intensive care Government medical college and hospital

Chandigarh
CHANDIGARH
160030
India 
Phone  9855203232  
Fax    
Email  alishachachra20@yahoo.co.in  
 
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 Government Medical College and Hospital
D Block Level 5 Anaesthesia and Intensive Care
Chandigarh
CHANDIGARH
160030
India 
Phone  9646121649  
Fax    
Email  vanitaanupam@gnail.com  
 
Source of Monetary or Material Support  
Department of anaesthesia Government medical college and hospital Sector-32 Chandigarh 
 
Primary Sponsor  
Name  Government Medical College and Hospital  
Address  Anaesthesia and Intensive Care D-Block fifth floor Government medical college and hospital Sector-32 Chandigarh 
Type of Sponsor  Government 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 
Dr Vanita Ahuja  Government medical college and hospital  Department of anaesthesia and intensive care D block fifth floor
Chandigarh
CHANDIGARH 
9646121649

vanitaanupam@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group I  30 patients will be given 150 mg pregabalin 2 h prior to surgery and once a day for two days after the surgery.  
Comparator Agent  Group II  30 patients will be given 60 mg duloxetine 2 h prior to surgery and once a day for two days after the surgery.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  American Society of Anesthesiologists (ASA) physical status I and II
Surgery of unilateral tibia or femur following trauma less than one month 
 
ExclusionCriteria 
Details  1. Patients having head injury and/or polytrauma including bilateral fractures.

2. Patients having coagulopathy.

3. Patients with Patient Health questionnaire-9 (PHQ-9) and Generalised Anxiety Disorder-7
(GAD-7) > 4.
4. Patients taking medications for chronic pain.

5. Patients with contraindications to pregabalin, duloxetine and diclofenac.

6. Pregnant and lactating women.

7. Patients not able to understand VAS.

8. Patients having history of substance abuse.  
 
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 
Time to first recue analgesia   Time When patient takes first recue analgesia  
 
Secondary Outcome  
Outcome  TimePoints 
1. Total cumulative rescue analgesia
2. VAS at rest and VAS on movement
3. Patient demographics and socioeconomic status
4. Haemodynamics.
5. Anxiety and depression score
6. Nausea and vomiting scale
7. Ramsay sedation score
8. Patient satisfaction score
9.VNRS at rest
VNRS on movement
 
1.At 72 hrs
2.preoperative, postoperative
period, at 4, 8, 12, 24, 48 and 72 h
3.before surgery
4. preoperatively, in postoperative period, at 4, 8, 12, 24, 48 and 72 h
5.preoperative visit and at 72 h postoperatively in ward
6.postoperative period, at
4, 8, 12, 24, 48 and 72h postoperatively in ward
7.preoperatively,immediate postoperative period, at 4, 8,
12, 24, 48 and 72h postoperatively in ward.
8.72 h postoperatively and postoperative 3 months
9, postoperative 3 months
 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   01/03/2019 
Date of Study Completion (India) 17/02/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  

Lower limb trauma comprises a significant portion of trauma surgeries and the most common complaint is pain.The available modalities in multimodal pain management include pharmacological, peripheral nerve blocks and neuraxial analgesia. However, opioids have undesirable side effects like respiratory depression, nausea/vomiting, constipation, sedation and sometimes physical dependence. Opioids also cause gastrointestinal hemorrhage, renal dysfunction and decreased hemostasis. Gabapentinoids is a class of anticonvulsants used in pain management due to good postoperative analgesia, safety profile, better tolerance and fewer drug interactions. Gabapentin and pregabalin are the gabapentioids which are used. Trauma also causes nerve damage which results in posttraumatic neuropathic pain. Thus, neuropathic pain is an element of trauma. Duloxetine is an antidepressant which possesses analgesic effect.There are encouraging results of duloxetine and pregabalin in literature but it is scant in comparison of analgesic efficacy of pregabalin versus duloxetine for postoperative pain relief in trauma patients undergoing lower limb surgeries. We hypothesize that difference exists between response rates in terms of rescue analgesia and postoperative pain relief with the use of either pregabalin or duloxetine. Hence, this trial is planned to compare the response rates of rescue analgesic requirement with perioperative pregabalin or duloxetine in trauma patients undergoing lower limb surgeries.

 
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