A Single Preoperative Dose of Gabapentin to Decreases Pos... | NCT05533684

Studies
A Single Preoperative Dose of Gabapentin to Decreases Postoperative Pain in Ambulatory Anal Surgeries

NCT05533684

Sponsor

Minia University

Status

Completed

Last Update Posted

Mar 16, 2023Actual

Enrollment

50Actual

Phase

Early Phase 1

Conditions

Pain, Postoperative

Interventions

Gabapentin

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2022Actual

Primary Completion Date

Dec 31, 2022Actual

Completion Date

Dec 31, 2022Actual

First Submitted Date

Sep 3, 2022

First Submission Date that Met QC Criteria

Sep 7, 2022

First Posted Date

Sep 9, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 15, 2023

Last Update Posted Date

Mar 16, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Single dose 600 mg gabapentin will be given preoperatively in anal surgeries

Detailed Description

Patients will be grouped into 2 groups of 25 patients each, the first group will receive 600 mg of gabapentin one hour before surgery and the second group will receive a placebo tablet. pain scores will be measured postoperatively

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
postoperative pain	No Intervention	Measuring postoperative pain using the visual analogue scale
total analgesic consumption	Other	Recording the total amount of analgesia consumed by the patients	Drug: Gabapentin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gabapentin	Drug	single preoperative dose of 600 mg gabapentin	total analgesic consumption

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
postoperative pain	measuring postoperative pain using the visual analog scale from 0 to 10, where zero is the least, and 10 is the worst pain	first 12 hours postoperative

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ASA physical status I or II
Aged from 18 to 65 years
Scheduled for anal surgeries at Minya University Hospital

Exclusion Criteria:

Presence of contraindications to neuraxial anesthesia
Presence of history of central nervous system or mental disorders, epilepsy, chronic pain, or drug abuse.
The use of neuropathic analgesic or antiepileptic drugs

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sarah Omar, M.D.	Minia University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sarah Omar		Minya		61111	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

The research will be available to other researchers when it is completed

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077206	Gabapentin

Ancestor Terms

ID	Term
D000588	Amines
D009930	Organic Chemicals
D005680	gamma-Aminobutyric Acid
D000613	Aminobutyrates

Browse Leaves

Not provided

Browse Branches

Not provided