Analgesic Efficacy of Pre-operative Oral Pregabalin in Dacryocystorhinostomy Surgery
Condition: Dacryocystitis
MeSH terms: Dacryocystitis
Study type: Interventional

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.
    

Intervention name(s): Pregabalin 150mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Two capsules of pregabalin is administered orally to patients; Two identical placebo capsules is administered orally to patients
Other intervention name(s): Lyrica; Control
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pregabalin; Dacryocystorhinostomy; Analgesia