NCT07389551

Brief Summary

There are extensive gaps in the local data considering pregabalin versus gabapentin as pre-emptive analgesics in patients undergoing orthopedic surgeries under spinal anesthesia. Therefore, the current study was planned with the objective of comparing pregabalin versus gabapentin as pre-emptive analgesics in patients undergoing orthopedic surgeries under spinal anesthesia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
142

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 5, 2026

Completed
Last Updated

February 5, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

January 29, 2026

Last Update Submit

January 29, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Pain severity

    The severity of pain was analyzed on the visual analogue scale (VAS), with a lower score labelling the effectiveness of the treatment.

    24 hours

  • Analgesia duration

    The duration of analgesia was measured from awakening to the need of rescue analgesia, when a pain score was more than 3 on VAS.

    24 hours

Study Arms (2)

Group-G

EXPERIMENTAL

Patients were given a single oral dose of gabapentin 300 mg, with 30 ml of water, one hour prior to administration of spinal anesthesia.

Drug: Gabapentin

Group-P

EXPERIMENTAL

Patients received pregabalin 150 mg as a single oral dose, with 30 ml of water, one hour prior to administration of spinal anesthesia

Drug: Pregabalin

Interventions

Patients were given a single oral dose of gabapentin 300 mg, with 30 ml of water, one hour prior to administration of spinal anesthesia.

Group-G

Patients received pregabalin 150 mg as a single oral dose, with 30 ml of water, one hour prior to administration of spinal anesthesia.

Group-P

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Either gender
  • Aged 20-60 years
  • Undergoing lower limb orthopedic surgeries under spinal anesthesia

You may not qualify if:

  • Patients with a previous history of spine interventions, including surgery or injections (transforaminal, epidural, or facetal) for pain relief
  • Patients under any sort of pain modulation therapy, like transcutaneous electrical nerve stimulation
  • Patients had a long-term history of any analgesia use
  • Those with psychiatric disorders, alcohol/drug dependence, hepatic, renal, cardiac, or pulmonary abnormalities,
  • With a history of allergies to gabapentinoids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Victoria Hospital/Qaid-e-Azam Medical College

Bahawalpur, Punjab Province, 63100, Pakistan

Location

MeSH Terms

Interventions

GabapentinPregabalin

Intervention Hierarchy (Ancestors)

AminesOrganic Chemicalsgamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsCyclohexanecarboxylic AcidsAcids, CarbocyclicCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Muhammad Usman

    Bahawal Victoria Hospital/Quid-e-Azam Medical College, Bahawalpur

    PRINCIPAL INVESTIGATOR
  • Ambreen Khan, FCPS

    Bahawal Victoria Hospital/Quid-e-Azam Medical College, Bahawalpur

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Consultant

Study Record Dates

First Submitted

January 29, 2026

First Posted

February 5, 2026

Study Start

July 1, 2025

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

February 5, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Data can be shared on a reasonable request.

Locations