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Analgesic Efficacy of Pre-operative Oral Pregabalin in Dacryocystorhinostomy Surgery

Primary Purpose

Dacryocystitis

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Pregabalin 150mg
Placebo
Sponsored by
Sameh Fathy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dacryocystitis focused on measuring Pregabalin, Dacryocystorhinostomy, Analgesia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Anesthesia, Mansoura University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Pregabalin Group

Control Group

Arm Description

Patients received two capsules: one at the night of surgery, and the other at 2 hours before the surgery

Patients received two capsules: one at the night of surgery, and the other at 2 hours before the surgery

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Changes in heart rate
Heart rate (beat/min) is recorded at five-minute intervals until 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
First analgesic request
The time of the first analgesic request for pethidine is recorded.
Total analgesic requirements of pethidine
The amount of pethidine consumption given as a rescue analgesia to patients is measured all over the 24 hours.
Incidence of postoperative nausea and vomiting
Incidence of postoperative nausea and vomiting is assessed up to 24 hours after the procedure

Full Information

First Posted
July 10, 2022
Last Updated
July 12, 2022
Sponsor
Sameh Fathy
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1. Study Identification

Unique Protocol Identification Number
NCT05455944
Brief Title
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

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
December 30, 2020 (Actual)
Study Completion Date
December 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sameh Fathy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dacryocystitis
Keywords
Pregabalin, Dacryocystorhinostomy, Analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pregabalin Group
Arm Type
Active Comparator
Arm Description
Patients received two capsules: one at the night of surgery, and the other at 2 hours before the surgery
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Patients received two capsules: one at the night of surgery, and the other at 2 hours before the surgery
Intervention Type
Drug
Intervention Name(s)
Pregabalin 150mg
Other Intervention Name(s)
Lyrica
Intervention Description
Two capsules of pregabalin is administered orally to patients
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Control
Intervention Description
Two identical placebo capsules is administered orally to patients
Primary Outcome Measure Information:
Title
Changes in pain scores by visual analogue scale (VAS)
Description
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
Secondary Outcome Measure Information:
Title
Changes in heart rate
Description
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
Title
Changes in mean arterial blood pressure
Description
Blood pressure (mmHg) is recorded at five-minute intervals until the end of the surgery
Time Frame
Up to the end of the surgery
Title
First analgesic request
Description
The time of the first analgesic request for pethidine is recorded.
Time Frame
Up to 24 hours after the procedure
Title
Total analgesic requirements of pethidine
Description
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
Title
Incidence of postoperative nausea and vomiting
Description
Incidence of postoperative nausea and vomiting is assessed up to 24 hours after the procedure
Time Frame
Up to 24 hours after the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sameh M Elsherbiny, MD
Organizational Affiliation
Mansoura Faculty of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Department of Anesthesia, Mansoura University Hospitals
City
Mansoura
State/Province
Dakahlia
ZIP/Postal Code
35511
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Analgesic Efficacy of Pre-operative Oral Pregabalin in Dacryocystorhinostomy Surgery

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