| 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
|
|
|
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
|
|
|
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. |