the Effect of Pregabalin on Postoperative Pain and Opioid Consumption in Spine Surgery

NCT05083793 | Unknown Phase 2

• 1 other identifier: 17101526
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The effect of pregabalin on post-operative pain and opioid consumption in spine surgery, a prospective, randomized, controlled study

Conditions

Postoperative Pain

Keywords

pregabalin

Outcome Measures

Primary Outcomes (1)

• Morphia dose

  the total amount of rescue morphine received by patients for 24h postoperatively.

  24 hour postoperative

Secondary Outcomes (1)

• Postoperative pain

  24 hour postoperative

Study Arms (2)

Study group

EXPERIMENTAL

patients have spine surgery receive oral pregabalin 150 mg 1 hour before surgery

Drug: Pregabalin 150mg

Placebo group

PLACEBO COMPARATOR

patients will receive placebo 1 hour before surgery with a sip of water.

Other: Placebo

Interventions

Pregabalin 150mg DRUG

The effect of pregabalin on post-operative pain

Also known as: Pregabalin

Study group

Placebo OTHER

patients will receive placebo one hour before operation

Placebo group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• : This prospective randomized clinical study will include eighty patients with ASA I-II, aged 18-60 years scheduled for spine surgery

You may not qualify if:

• : Excluded from the study are patients with known allergy to the study drugs, significant cardiac, respiratory, renal, CNS or hepatic disease, drug or alcohol abuse, pregnant women, patients refusing participation and psychiatric or mental illness that would interfere with perception and assessment of pain.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Mahmoud Maher

Asyut, 11174, Egypt

Location

Related Publications (3)

• Ben-Menachem E. Pregabalin pharmacology and its relevance to clinical practice. Epilepsia. 2004;45 Suppl 6:13-8. doi: 10.1111/j.0013-9580.2004.455003.x.

  PMID: 15315511 BACKGROUND

• Hindmarch I, Trick L, Ridout F. A double-blind, placebo- and positive-internal-controlled (alprazolam) investigation of the cognitive and psychomotor profile of pregabalin in healthy volunteers. Psychopharmacology (Berl). 2005 Dec;183(2):133-43. doi: 10.1007/s00213-005-0172-7. Epub 2005 Nov 9.

  PMID: 16205916 BACKGROUND

• Sebastian B, Talikoti AT, Nelamangala K, Krishnamurthy D. Effect of Oral Pregabalin as Preemptive Analgesic in Patients Undergoing Lower Limb Orthopedic Surgeries under Spinal Anaesthesia. J Clin Diagn Res. 2016 Jul;10(7):UC01-4. doi: 10.7860/JCDR/2016/18854.8081. Epub 2016 Jul 1.

  PMID: 27630927 BACKGROUND

Related Links

• Pregabalin pharmacology and its relevance to clinical practice

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Mahmoud Maher, MD

  Assiut University Hospitals

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: care provider
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of anesthesia and intensive care

Study Record Dates

• First Submitted: October 6, 2021
• First Posted: October 19, 2021
• Study Start: April 1, 2020
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: October 19, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: one year
• Access Criteria: Study protocol

Locations

EG (1)