NCT04700592

Brief Summary

Patients were randomized into two groups: Group Gabapentine ( G group) received 600 mg of Gabapentin (two tablets) two hours prior to surgery and saline solution before induction of spinal anesthesia and group Ketamine ( K group) received two placebo tablets and an injection of ketamine at a dosage of 0.15 mg/Kg before induction of spinal anesthesia.. During the surgery, blood pressure and heart rate were monitored. Postoperative analgesia was provided by a PCA morphine. Acute postoperative pain was assessed by a visual analog scale. The incidence of postoperative neuropathic pain was detected by the DN4 questionnaire after one and three months of surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2020

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 2, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 2, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 8, 2021

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2021

Completed
Last Updated

June 3, 2021

Status Verified

May 1, 2021

Enrollment Period

4 months

First QC Date

January 2, 2021

Last Update Submit

May 30, 2021

Conditions

Chronic Pain Following Surgical Procedure for Cancer

Keywords

post operative chronic paingabapentinketaminInguinal Hernia Repair

Outcome Measures

Primary Outcomes (1)

  • postoperative neuropathic pain

    the DN4 questionnaire

    three months of surgery

Secondary Outcomes (2)

  • acute pain postoperative

    At twenty-four hour postoperative

  • Consumption of morphine

    At 24 hour postoperative

Study Arms (2)

Gabapentin group

EXPERIMENTAL

group which receives 600 mg of Gabapentin (two tablets) one hour prior to surgery

Other: Gabapentin versus Ketamine

ketamine group

EXPERIMENTAL

group which receives an injection of ketamine at a dosage of 0.15 mg/Kg before surgery incision

Other: Gabapentin versus Ketamine

Interventions

Gabapentin versus KetamineOTHER

A Comparison of Gabapentin and Ketamine in Acute and Chronic Pain

Also known as: acute and Chronic Pain
Gabapentin groupketamine group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA I and II
  • Inguinal Hernia Repair in non emergent conditions

You may not qualify if:

  • Patients with significant cardiovascular central nervous system disease, renal or liver failure could not operate the PCA device

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mechaal Benali

Nabeul, 8000, Tunisia

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • mechaal benali, PROFESSOR

    university manar Tunis tunisia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 2, 2021

First Posted

January 8, 2021

Study Start

October 2, 2020

Primary Completion

February 2, 2021

Study Completion

February 2, 2021

Last Updated

June 3, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)