Skip to main content
OpenTrials
Completed

NCT Number: NCT05455944

Analgesic Efficacy of Pre-operative Oral Pregabalin in Dacryocystorhinostomy Surgery

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesia, Mansoura University Hospitals

Al Mansurah, Dakahlia Governorate, 35511, Egypt

About this study

External dacryocystorhinostomy (DCR) is still considered the golden standard for lacrimal surgery. It is a bypass technique which creates an anastomosis between the lacrimal sac and the nasal mucosa through a bony ostium via an external skin incision. External DCR can be completed under either local or general anesthesia. It is a painful surgical procedure that involves intra- and extra-ocular dissection, with a high prevalence post-operative nausea and vomiting (PONV). So, it is necessary to ensure a stress-free peri-operative period with adequate pain relief and a low incidence of PONV after DCR surgery.

Pregabalin is a lipophilic gamma-amino-butyric acid (GABA) analogue that binds to the voltage-gated calcium channels. It reduces the excitability of the dorsal horn neurons after tissue damage. It has anticonvulsant, anxiolytic and sleep-modulating properties. It was shown to be effective in several models of neuropathic pain, incisional injury, and inflammatory injury.

Preoperative administration of pregabalin is supposed to be a promising technique of enhancing postoperative pain control and reduction in postoperative opioid consumption.

This study is a prospective randomized double-blind clinical trial included 100 ASA I and II patients of both sex with age between 18 and 65 years old, who are planned for elective DCR surgery under general anesthesia in Mansoura University ophthalmology center. Informed written consent is obtained from all subjects in the study after ensuring confidentiality. Details of the anesthetic technique and the study protocol are clarified to the entire involved cases. Patients are randomly assigned to two equal groups according to computer-generated randomization schedule.

A prospective analysis of the collected data is performed using the Statistical Package for the Social Sciences (SPSS) program for Windows (version 22). All data are considered statistically significant if P value is ≤ 0.05.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Pregabalin 150mg

Drug

Two capsules of pregabalin is administered orally to patients

Other names: Lyrica

Placebo

Drug

Two identical placebo capsules is administered orally to patients

Other names: Control

Primary outcomes

  1. Changes in pain scores by visual analogue scale (VAS)

    Time frame: Up to 24 hours after the procedure

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

Secondary outcomes

  1. Changes in heart rate

    Time frame: Up to the end of the surgery

    Heart rate (beat/min) is recorded at five-minute intervals until the end of the surgery

  2. Changes in mean arterial blood pressure

    Time frame: Up to the end of the surgery

    Blood pressure (mmHg) is recorded at five-minute intervals until the end of the surgery

  3. First analgesic request

    Time frame: Up to 24 hours after the procedure

    The time of the first analgesic request for pethidine is recorded.

  4. Total analgesic requirements of pethidine

    Time frame: Up to 24 hours after the procedure

    The amount of pethidine consumption given as a rescue analgesia to patients is measured all over the 24 hours.

  5. Incidence of postoperative nausea and vomiting

    Time frame: Up to 24 hours after the procedure

    Incidence of postoperative nausea and vomiting is assessed up to 24 hours after the procedure

Sponsors and collaborators

Lead sponsor

Sameh Fathy

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Jul 13, 2022
Registry last updated
Jul 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.