The Effect of Oral Pregabalin on Epidural-induced Shivering and Epidural Characteristics

NCT03721432 | Completed

• 1 other identifier: FM-BSU REC 006/2018
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

• Background: The previous reports tried to reduce shivering and improve neuroaxial anesthesia characteristics by the systemic use of different drugs. This study was directed to evaluate the effect of pregabalin premedication on both shivering and epidural outcome data following single shot loading.
• Patients and Methods: Eighty patients, ASA grade I and II, undergoing surgeries under epidural anesthesia were studied. The patients were divided into two groups: Pregabalin group and Control group in which the patients received 150 mg of pregabalin and placebo capsules respectively sixty minutes prior to surgery. Following epidural loading, the onset and degree of shivering were compared between the two groups. Also, the epidural outcome including onset, level and duration were traced and compared. The perioperative hemodynamics, sedation scores, patient satisfaction and side effects were followed up and registered.

Conditions

Epidural Anesthesia; Shivering

Outcome Measures

Primary Outcomes (2)

• - Shivering

  incidence of positive shivering ,

  starting from epiural injection, up to 60 minutes after epidural anesthesia

• Shivering

  incidence of maximum shivering

  starting from epiural injection, up to 60 minutes after epidural anesthesia

Secondary Outcomes (2)

• - Epidural characteristics

  from epidural injection till numbing sensation (approximately 10 minutes)

• Epidural characteristics

  from epidural onset to starting feeling pain (approximately 90 minutes)

Study Arms (2)

Pregabalin group (P)

EXPERIMENTAL

received pregabalin 150 mg capsules (Lyrica®,Pfizer) sixty minutes prior to the epidural insertion.

Drug: Pregabalin 150mg

Control group (C)

PLACEBO COMPARATOR

received placebo capsules sixty minutes prior to epidural insertion.

Drug: Placebo oral capsule

Interventions

Pregabalin 150mg DRUG

pregabalin 150 mg capsules (Lyrica®,Pfizer) given 60 minutes prior to epidural anesthesia

Also known as: Lyrica

Pregabalin group (P)

Placebo oral capsule DRUG

Placebo oral capsule given 60 minutes prior to epidural anesthesia

Control group (C)

Eligibility Criteria

• Age: 20 Years - 60 Years
• Gender Eligibility Details: female patients
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• adults female patients (20 - 60 years old)
• with an American society of Anesthegiologists physical status (ASA) I-II
• undergoing gynecological surgery

You may not qualify if:

• ASA class was more than II,
• anticipated difficult epidural insertion
• any contraindication to epidural anesthesia, if any patient developed wet or bloody tab, or the patients were under psychotropic or antiepileptic therapy.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Beni suef university hospiital

Banī Suwayf, 62511, Egypt

Location

MeSH Terms

Interventions

Pregabalin

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: sealed opaque numbered envelopes indicating the group of each patient, carried out by an independent anesthesiologist and given to the ward nurse
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: October 10, 2018
• First Posted: October 26, 2018
• Study Start: May 20, 2018
• Primary Completion: November 15, 2018
• Study Completion: November 15, 2018
• Last Updated: January 23, 2019

Record last verified: 2019-01

Locations

EG (1)