Clinical trial NCT05455944: Analgesic Efficacy of Pre-operative Oral Pregabalin in Dacryocystorhinostomy Surgery
Official title: Analgesic Efficacy of Pre-operative Oral Pregabalin in Dacryocystorhinostomy Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dacryocystitis
Keywords: Pregabalin
Dacryocystorhinostomy
Analgesia
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2022-07-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in pain scores by visual analogue scale (VAS)
timeFrame: Up to 24 hours after the procedure
Secondary outcomes:
measure: Changes in heart rate
timeFrame: Up to the end of the surgery
measure: Changes in mean arterial blood pressure
timeFrame: Up to the end of the surgery
measure: First analgesic request
timeFrame: Up to 24 hours after the procedure
measure: Total analgesic requirements of pethidine
timeFrame: Up to 24 hours after the procedure
measure: Incidence of postoperative nausea and vomiting
timeFrame: Up to 24 hours after the procedure
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Department of Anesthesia, Mansoura University Hospitals
state: Dakahlia
Study officials:
affiliation: Mansoura Faculty of Medicine
name: Sameh M Elsherbiny, MD
role: STUDY_DIRECTOR
References: