Analgesic Efficacy of Pre-operative Oral Pregabalin in Dacryocystorhinostomy Surgery

NCT05455944 | Completed

• 1 other identifier: Pregabalin in DCR surgery
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study is conducted to evaluate the effects of preoperative oral pregabalin on postoperative pain and analgesic requirements in patients undergoing DCR surgery. The primary outcome is to compare pain scores by visual analogue scale (VAS). Secondary outcomes are the time of first analgesic request, the total analgesic requirements during the postoperative 24 hours, the incidence of PONV, in addition to effect on hemodynamic parameters between the two groups.

Conditions

Dacryocystitis

Keywords

Pregabalin; Dacryocystorhinostomy; Analgesia

Outcome Measures

Primary Outcomes (1)

• Changes in pain scores by visual analogue scale (VAS)

  Pain (VAS) score from 0 to 10 (0 = no pain and 10 = the worst imaginable pain)

  Up to 24 hours after the procedure

Secondary Outcomes (5)

• Changes in heart rate

  Up to the end of the surgery

• Changes in mean arterial blood pressure

  Up to the end of the surgery

• First analgesic request

  Up to 24 hours after the procedure

• Total analgesic requirements of pethidine

  Up to 24 hours after the procedure

• Incidence of postoperative nausea and vomiting

  Up to 24 hours after the procedure

Study Arms (2)

Pregabalin Group

ACTIVE COMPARATOR

Patients received two capsules: one at the night of surgery, and the other at 2 hours before the surgery

Drug: Pregabalin 150mg

Control Group

PLACEBO COMPARATOR

Patients received two capsules: one at the night of surgery, and the other at 2 hours before the surgery

Drug: Placebo

Interventions

Pregabalin 150mg DRUG

Two capsules of pregabalin is administered orally to patients

Also known as: Lyrica

Pregabalin Group

Placebo DRUG

Two identical placebo capsules is administered orally to patients

Also known as: Control

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiology (ASA) I and II patients.
• Scheduled for DCR surgery.

You may not qualify if:

• Patient' refusal of consent.
• Mental, psychological or neurological disorders.
• Patients with history of drug or alcohol abuse.
• History of know sensitivity to the used drugs.
• Bleeding or coagulation diathesis.
• Obese patients (body mass index (BMI) \< 35).
• Pregnancy and lactation.

Sponsors & Collaborators

• Sameh Fathy: lead

Study Sites (1)

Department of Anesthesia, Mansoura University Hospitals

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Location

MeSH Terms

Conditions

Dacryocystitis; Agnosia

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Sameh M Elsherbiny, MD

  Mansoura Faculty of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer of anesthesia, ICU & pain management - Faculty of Medicine

Study Record Dates

• First Submitted: July 10, 2022
• First Posted: July 13, 2022
• Study Start: January 1, 2020
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2021
• Last Updated: July 14, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)