NCT04775992

Brief Summary

To address the preemptive analgesic effect of preoperative gabapentoids versus no gabapentoids in orthopedic surgery

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

February 25, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 1, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

March 1, 2021

Status Verified

February 1, 2021

Enrollment Period

5 months

First QC Date

February 25, 2021

Last Update Submit

February 25, 2021

Conditions

Acute Postoperative Pain

Keywords

acute postoperative painPreemptive analgesiaOrthopedic surgeryPreoperative gabapentoids

Outcome Measures

Primary Outcomes (2)

  • Postoperative pain score on rest

    Pain score by VAS on rest

    every hour for the first 24 hours

  • Postoperative pain during movement

    Pain score by VAS during movements

    every hour for the first 24 hours

Secondary Outcomes (4)

  • Worst pain score

    during the first 24 hours

  • Least pain score

    during the first 24 hours

  • Time spend in severe pain

    during the first 24 hours

  • Patient's satisfaction

    during the first 24 hours

Study Arms (2)

preemptive group

patients in this group will receive preoperative gabapentoids

Other: gabapentoids

control group

patients in this group will not receive gabapentoids

Other: gabapentoids

Interventions

gabapentoidsOTHER

Preemptive analgesia

control grouppreemptive group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

all included RCT

You may qualify if:

  • RCT, during last 10 years, involving orthopedic surgery

You may not qualify if:

  • non randomized trials, unavailable study data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Consultant - Anesthesia and Pain Management

Study Record Dates

First Submitted

February 25, 2021

First Posted

March 1, 2021

Study Start

March 1, 2021

Primary Completion

July 31, 2021

Study Completion

December 1, 2021

Last Updated

March 1, 2021

Record last verified: 2021-02