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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
Two capsules of pregabalin is administered orally to patients
Two identical placebo capsules is administered orally to patients
Department of Anesthesia, Mansoura University Hospitals
Al Mansurah, Dakahlia Governorate, Egypt
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)
Time frame: Up to 24 hours after the procedure
Changes in heart rate
Heart rate (beat/min) is recorded at five-minute intervals until the end of the surgery
Time frame: 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
Time frame: Up to the end of the surgery
First analgesic request
The time of the first analgesic request for pethidine is recorded.
Time frame: 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.
Time frame: 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
Time frame: Up to 24 hours after the procedure
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