Comparison of Pregabalin with Duloxetine for Pain management.

A Comparative study of Duloxetine with Pregabalin as Preemptive Analgesic in lumbar spine surgery.

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/03/024306

Enrollment

Registered

2020-03-27

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G958- Other specified diseases of spinalcord Health Condition 2: G958- Other specified diseases of spinalcord

Interventions

Intervention1: Duloxetine: ONE Tablet Duloxetine 20 mg OD HS Oral route for 3 days, followed by, ONE Tab of 20 mg BD Oral route for the next 4 days till the day of Surgery. Control Intervention1: Preg

Eligibility

Inclusion criteria

Inclusion criteria: ASA grade I and II Patients undergoing Elective Lumbar Spine Surgery

Exclusion criteria

Exclusion criteria: Patient refusal. History of opioid allergy. Hypersensitivity to any of the study drug used. Hepatic, renal or coagulation disorder. Contraindication to any of the drug used during study. History of any Psychiatric Disorder

Design outcomes

Primary

Measure	Time frame
To compare the analgesic efficacy (in terms of time of requirement for first dose of rescue analgesic) of Oral Duloxetine with Oral Pregabalin in Patients undergoing elective Lumbar Spine SurgeriesTimepoint: Each patient will be monitored for 24 hrs in HDU/ICU.	—

Secondary

Measure	Time frame
To compare the Pain Score using NRS Post Operatively for 24 hrs in both the groups. Total analgesic requirement in the first 24 hrs in both the groups. Total analgesic requirement intraoperatively in terms of fentanyl boluses in both the groups. Time to rescue Analgesia in both the groups. Patient satisfaction score in both the groups. Hemodynamic stability intra operatively in both the groups. Side effect of any drug used in both the groups. Recovery time in both the groups.Timepoint: A resident doctor blinded to the patientâ??s group assignment will assess time to first rescue analgesic (the time interval between full recovery and the time at which NRS was perceived by the patient to be 4 or more) and the total amount of analgesic requirement in the first 24 hrs. Post-operative pain using NRS starting from 0 time (patientâ??s full recovery in PACU) and then at 2, 4, 6, 12 and 24 hours postoperatively.	—

Measure

Time frame

To compare the Pain Score using NRS Post Operatively for 24 hrs in both the groups. Total analgesic requirement in the first 24 hrs in both the groups. Total analgesic requirement intraoperatively in terms of fentanyl boluses in both the groups. Time to rescue Analgesia in both the groups. Patient satisfaction score in both the groups. Hemodynamic stability intra operatively in both the groups. Side effect of any drug used in both the groups. Recovery time in both the groups.Timepoint: A resident doctor blinded to the patientâ??s group assignment will assess time to first rescue analgesic (the time interval between full recovery and the time at which NRS was perceived by the patient to be 4 or more) and the total amount of analgesic requirement in the first 24 hrs. Post-operative pain using NRS starting from 0 time (patientâ??s full recovery in PACU) and then at 2, 4, 6, 12 and 24 hours postoperatively.

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Countries

India

Contacts

Public ContactS M Arman

Jawaharlal Nehru Medical College and Hospital, AMU, Aligarh.

obaidahmad2008@gmail.com9897695761

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026