Analgesic Efficacy of Pre-operative Oral Pregabalin in Dacryocystorhinostomy Surgery

Dacryocystitis Clinical Trial

Official title:

Analgesic Efficacy of Pre-operative Oral Pregabalin in Dacryocystorhinostomy Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05455944
• Other study ID #: Pregabalin in DCR surgery
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: December 30, 2021

Study information

• Verified date: July 2022
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dacryocystitis

Intervention

Drug:
• Pregabalin 150mg
Two capsules of pregabalin is administered orally to patients
• Placebo
Two identical placebo capsules is administered orally to patients

Locations

Country	Name	City	State
Egypt	Department of Anesthesia, Mansoura University Hospitals	Mansoura	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Sameh Fathy

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	First analgesic request	The time of the first analgesic request for pethidine is recorded.	Up to 24 hours after the procedure
Secondary	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
Secondary	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