| CTRI Number |
CTRI/2025/07/091697 [Registered on: 25/07/2025] Trial Registered Prospectively |
| Last Modified On: |
24/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
The effect of duloxetine in recovery and pain after thoracolumbar spine surgery |
|
Scientific Title of Study
|
Effect of perioperative duloxetine on postoperative quality of recovery and analgesia after thoracolumbar spine 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 |
Ashima |
| Designation |
Post graduate Junior Resident |
| Affiliation |
Government Medical College and Hospital, Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, Block D, Level 5, GMCH, Sector 32B, Chandigarh, India
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9056304030 |
| Fax |
|
| Email |
singlaa19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jasveer Singh |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital, Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, Block D, Level 5, GMCH, Sector 32B, Chandigarh, India
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121664 |
| Fax |
|
| Email |
drjassy18@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jasveer Singh |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital, Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, Block D, Level 5, GMCH, Sector 32B, Chandigarh, India
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121664 |
| Fax |
|
| Email |
drjassy18@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia and Intensive Care, Block D, Level 5, Government Medical College and Hospital, Sector 32B, Chandigarh, 160030 |
|
|
Primary Sponsor
|
| Name |
Government Medical College and Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Block D, Level 5, Government Medical College and Hospital, Sector 32B, Chandigarh, 160030 |
| 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 Ashima |
Government Medical College and Hospital, Chandigarh |
Department of Anaesthesia and Intensive Care, Block D, Level 5, Government Medical College and Hospital, Sector 32B, Chandigarh, 160030
Chandigarh
CHANDIGARH |
9056304030
singlaa19@gmail.com |
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Duloxetine 60 mg tablet |
Duloxetine 60mg tablet will be given 2 hours before and 24 hours after by oral route in patient undergoing thoracolumbar spine surgery |
| Comparator Agent |
Placebo tablet |
Placebo will be given 2 hours before and 24 hours after by oral route in patient undergoing thoracolumbar spine surgeries and it’s effect wil be compared with duloxetine |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age between 18 and 65 years
Patients undergoing thoracolumbar spine surgeries requiring single level pedicle screw fixation- without having any neurological deficit
ASA Grade I or II
Body mass index between 18 and 35 |
|
| ExclusionCriteria |
| Details |
Patient’s refusal for consent
History of drug abuse
Severe cardiovascular, respiratory, neurological or metabolic disease
Chronic analgesia use
Patients having any drug allergy to duloxetine or morphine
Inability of the patient to understand the QoR -15 questionnaire
Inability to operate a Patient controlled analgesia (PCA) pump
Inability of the patient to understand Visual Analogue Score |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post operative QoR score at 48 hours |
It is assessed at 48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Cumulative opioid consumption |
It is assessed at 48 hours after surgery |
| Visual Analogue Scores assessment |
It is done at 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 24 hours and 48 hours after surgery |
| Patient satisfaction score by a 4 point verbal score |
It is assessed at 48 hours after surgery |
| Side effects of drug if any experienced |
It is done at 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 24 hours and 48 hours after surgery |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
18/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
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
|
A total number of 70 patients undergoing thoracolumbar spinal surgery will be randomly allocated to two groups of 35 patients each using computer generated random table and allotted number will be secured in a coded opaque sealed envelope. The patients will be allocated to one of the following two groups: Group D( n=35): Patients will receive duloxetine 60mg orally 2 hours before surgery and another tablet after 24 hours in the next morning. Group C (n=35); Patients will receive identical placebo orally 2 hours before surgery and another tablet after 24 hours in the next morning.
Procedure on day of surgery: Patient will be shifted to the operation room. Monitoring of heart rate, systolic blood pressure, diastolic blood pressure, mean arterial blood pressure, continuous electrocardiogram, respiratory rate and oxygen saturation will be done. Baseline vitals will be noted. All the patients will receive a standardised general anaesthesia using propofol 2mg/kg as inducing agent and vecuronium 0.1 mg/kg as muscle relaxant. Anaesthesia will be maintained by N2O/O2 in ratio 60:40 with sevoflurane. The surgery will proceed. Patient will be extubated after surgery and shifted to post anaesthesia care unit (PACU). Patients in both study groups will be connected to IV-PCA Pump (Micrel Rythmic TM evolution PCA) with 1mg/ml morphine with a lockout interval of 5 minutes.
Patients vitals will be monitored intra and post operatively and observations will be recorded in the prescribed performa. Post operative QoR score at 48 hours, cumulative morphine consumption, VAS scores, time to first bolus of morphine, satisfaction scores and side effects will be assessed and filled in prescribed performa. |