Oral Pregabalin Premedication for Postoperative Pain Relief

NCT04708353 | Unknown

• 1 other identifier: 19-11-2020
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Pain management after gynecological surgeries is essential for early mobilization of the patient, decrease postoperative complication and hospital stay. The use of opioids is associated with adverse effects such as nausea, vomiting, ileus, pruritus, sedation and respiratory depression. Previous studies stated that pregabalin has been used to reduce pre-operative anxiety, acute postoperative pain, postoperative opioid requirements, postoperative nausea, vomiting and postoperative delirium. The most effective dose of pregabalin to relief postoperative pain with least side effect is still under trial. In this study we will compare between two different doses of pregabalin when given as oral premedication in patients undergoing gynecological surgeries under spinal anesthesia regarding postoperative pain in order to reduce opioids consumption and subsequently avoid opioid-related adverse effects.

Conditions

Gynecologic Disease

Keywords

Oral Pregabalin; Postoperative Pain Relief; Gynecological Surgeries

Outcome Measures

Primary Outcomes (1)

• changes in Postoperative pain

  will be assessed by visual analogue scale (VAS), On a scale of 0-10, the patient will learn to quantify postoperative pain where 0= No pain and 10= Maximum worst pain.

  at 2, 4, 6, 8, 10, 12, 16, 20 and 24 hours postoperatively

Secondary Outcomes (2)

• The level of sedation

  at 2, 4, 6, 8, 10, 12, 16, 20 and 24 hours postoperatively

• Total amount of rescue analgesic

  in the first 24 hours

Study Arms (3)

control group

PLACEBO COMPARATOR

the patient will receive one placebo capsule (vitamin c) once one hour before the operation.

Drug: placebo capsule (vitamin c)

Group Pregabalin 150

ACTIVE COMPARATOR

the patient will receive one capsule of pregabalin 150 mg once one hour before the operation

Drug: Group pregabalin 150

Group Pregabalin 300

ACTIVE COMPARATOR

the patient will receive one capsule of pregabalin 300 mg once one hour before the operation

Drug: Group pregabalin 300

Interventions

placebo capsule (vitamin c) DRUG

the patient will receive one placebo capsule (vitamin c) once one hour before the operation

control group

Group pregabalin 150 DRUG

the patient will receive one capsule of pregabalin 150 mg once one hour before the operation

Also known as: p150

Group Pregabalin 150

Group pregabalin 300 DRUG

the patient will receive one capsule of pregabalin 300 mg once one hour before the operation

Also known as: p300

Group Pregabalin 300

Eligibility Criteria

• Age: 21 Years - 60 Years
• Gender Eligibility Details: Female patients scheduled for benign gynecological surgeries (abdominal hysterectomy, myomectomy, adnexal mass or disturbed ectopic pregnancy) under spinal anesthesia.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Physical status: ASA I-II
• BMI ≥ 20kg/m2 \& ≤ 35kg/m2,
• Written informed consent from the patient.

You may not qualify if:

• Patients with known history of allergy to study drugs,
• Patients on ACE inhibitors, anticonvulsant therapy or any drug interacting with pregabalin,
• Patients on chronic alcohol, opioid, tranquilizer or sedative use,
• Patient with renal impairment or heart failure,
• Pregnant females, Psychological, mental disorders or depression,
• Patients receiving anticoagulants therapy or suspected coagulopathy,
• Patients already on pregbalin or gabapentin therapy.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

faculty of medicine, Zagazig university

Zagazig, Elsharqya, 44519, Egypt

RECRUITING

Related Publications (4)

• Guay DR. Pregabalin in neuropathic pain: a more "pharmaceutically elegant" gabapentin? Am J Geriatr Pharmacother. 2005 Dec;3(4):274-87.

  PMID: 16503325 BACKGROUND

• Dahl JB, Mathiesen O, Moiniche S. 'Protective premedication': an option with gabapentin and related drugs? A review of gabapentin and pregabalin in in the treatment of post-operative pain. Acta Anaesthesiol Scand. 2004 Oct;48(9):1130-6. doi: 10.1111/j.1399-6576.2004.00484.x.

  PMID: 15352959 BACKGROUND

• Mishriky BM, Waldron NH, Habib AS. Impact of pregabalin on acute and persistent postoperative pain: a systematic review and meta-analysis. Br J Anaesth. 2015 Jan;114(1):10-31. doi: 10.1093/bja/aeu293. Epub 2014 Sep 10.

  PMID: 25209095 BACKGROUND

• Balaban F, Yagar S, Ozgok A, Koc M, Gullapoglu H. A randomized, placebo-controlled study of pregabalin for postoperative pain intensity after laparoscopic cholecystectomy. J Clin Anesth. 2012 May;24(3):175-8. doi: 10.1016/j.jclinane.2011.06.027. Epub 2012 Mar 28.

  PMID: 22459341 BACKGROUND

MeSH Terms

Conditions

Genital Diseases, Female

Interventions

Ascorbic Acid; Focal Adhesion Protein-Tyrosine Kinases; E1A-Associated p300 Protein

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Protein-Tyrosine Kinases; Protein Kinases; Phosphotransferases (Alcohol Group Acceptor); Phosphotransferases; Transferases; Enzymes; Enzymes and Coenzymes; Intracellular Signaling Peptides and Proteins; Proteins; Amino Acids, Peptides, and Proteins; p300-CBP Transcription Factors; Histone Acetyltransferases; Lysine Acetyltransferases; Acetyltransferases; Acyltransferases; Transcription Factors

Central Study Contacts

Asmaa M Galal, MD

CONTACT

01271550089; asmaa_galal79@yahoo.com

Rehab A Wahdan, MD

CONTACT

01003481323; obz13w@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: double-blinded ( patient and outcome assessors)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia and surgical intensive care

Model Details: The patients will be allocated randomly using computer generated randomization table into three equal groups

Study Record Dates

• First Submitted: November 23, 2020
• First Posted: January 13, 2021
• Study Start: August 20, 2020
• Primary Completion: October 1, 2021
• Study Completion: November 1, 2021
• Last Updated: September 5, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: planned after the completion of the study and publication
• Access Criteria: principal investigator

Locations

EG (1)