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.

Study Overview

• Status: Completed
• Conditions: Dacryocystitis
• Intervention / Treatment: Drug: Pregabalin 150mg; Drug: Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dakahlia
    • Mansoura, Dakahlia, Egypt, 35511
      • Department of Anesthesia, Mansoura University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Pregabalin Group; Patients received two capsules: one at the night of surgery, and the other at 2 hours before the surgery	Drug: Pregabalin 150mg; Two capsules of pregabalin is administered orally to patients; Other Names: Lyrica
PLACEBO_COMPARATOR: Control Group; Patients received two capsules: one at the night of surgery, and the other at 2 hours before the surgery	Drug: Placebo; Two identical placebo capsules is administered orally to patients; Other Names: Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in heart rate	Heart rate (beat/min) is recorded at five-minute intervals until the end of the surgery	Up to the end of the surgery
Changes in mean arterial blood pressure	Blood pressure (mmHg) is recorded at five-minute intervals until the end of the surgery	Up to the end of the surgery
First analgesic request	The time of the first analgesic request for pethidine is recorded.	Up to 24 hours after the procedure
Total analgesic requirements of pethidine	The amount of pethidine consumption given as a rescue analgesia to patients is measured all over the 24 hours.	Up to 24 hours after the procedure
Incidence of postoperative nausea and vomiting	Incidence of postoperative nausea and vomiting is assessed up to 24 hours after the procedure	Up to 24 hours after the procedure

Collaborators and Investigators

• Sponsor: Sameh Fathy
• Investigators: Study Director: Sameh M Elsherbiny, MD, Mansoura faculty of Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2020
• Primary Completion (ACTUAL): December 30, 2020
• Study Completion (ACTUAL): December 30, 2021

Study Registration Dates

• First Submitted: July 10, 2022
• First Submitted That Met QC Criteria: July 10, 2022
• First Posted (ACTUAL): July 13, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 14, 2022
• Last Update Submitted That Met QC Criteria: July 12, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Analgesia; Pregabalin; Dacryocystorhinostomy
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dacryocystitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Pregabalin
• Other Study ID Numbers: Pregabalin in DCR surgery

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No