NCT07297888

Brief Summary

the investigators have tested whether gabapentin is superior to clonidine top decrease the post operative pain during spinal surgeries as a part of their thesis study. the investigators are registering this study post date as the student forgot by mistake to do so.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Jul 2022

Typical duration for not_applicable pain

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 20, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2024

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 19, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 22, 2025

Completed
Last Updated

January 12, 2026

Status Verified

January 1, 2026

Enrollment Period

1.5 years

First QC Date

November 19, 2025

Last Update Submit

January 8, 2026

Conditions

Keywords

gabapentinclonidinepain

Outcome Measures

Primary Outcomes (1)

  • post operative pain

    Pain was assessed using the Visual Analog Scale (VAS) score ranging from 0 to 10. 10 being the worst pain and 0 being No pain

    1, 2, 4, 6, 8, 12, and 24 hours postoperatively.

Secondary Outcomes (1)

  • anxiety

    1, 2, 4, 6, 8, 12, and 24 hours postoperatively.

Study Arms (3)

clonide

ACTIVE COMPARATOR

In this group the investigators have given clonidine to the participants

Drug: Gabapentin

placebo

PLACEBO COMPARATOR

in this group no active drug was given to the participants

Drug: Gabapentin

gabapentin

ACTIVE COMPARATOR

In this group the investigators have given gabapentin to the participants

Drug: Gabapentin

Interventions

comparison of both these drugs to decrease pain

Also known as: clonidine
clonidegabapentinplacebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \- Eligible participants were aged 18-60 years, classified as ASA physical status I or II, and scheduled for one or two-level lumbar laminectomy.

You may not qualify if:

  • Patients with psychiatric disorders, autoimmune diseases, local infection, BMI \>35, emergency procedures, tumour surgeries and the patients requiring the postoperative ventilation were excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adabala Vijay Babu

Dehradun, Uttarakhand, 246001, India

Location

MeSH Terms

Conditions

Pain

Interventions

GabapentinClonidine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AminesOrganic Chemicalsgamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsCyclohexanecarboxylic AcidsAcids, CarbocyclicCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsAmino AcidsAmino Acids, Peptides, and ProteinsImidazolinesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ABabu

Study Record Dates

First Submitted

November 19, 2025

First Posted

December 22, 2025

Study Start

July 20, 2022

Primary Completion

January 20, 2024

Study Completion

March 20, 2024

Last Updated

January 12, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

we can share our research question and methodology whenever it is necessary

Shared Documents
STUDY PROTOCOL

Locations