Pregabalin Versus Gabapentin Opioid Sparing Effect in Discectomy

NCT05539924 | Unknown Phase 3

• 1 other identifier: 00arafa00
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Pregabalin and gabapentin are both GABA analogue and their mechanism of action is not fully understood. Both drugs when given as a pre-emptive analgesia for spinal surgery were found to reduce intra-and postoperative opioid requirements. Preoperative intramuscular injection of morphine could reduce the patients' pain during the percutaneous transformational endoscopic discectomy "PTED" surgery and improve the patients' satisfaction without affecting the surgical outcome. The efficacy of adding pregabalin or gabapentin to preoperative intramuscular morphine is not yet investigated. The current study aims to compare the analgesic effect of both drugs when given preoperatively with intramuscular morphine.

Conditions

Opioid Use

Outcome Measures

Primary Outcomes (1)

• time to first rescue analgesia during the first postoperative 24 hours.

  call for analgesia

  24 hours

Secondary Outcomes (1)

• pain score

  24 hours post operative

Study Arms (3)

Group P

ACTIVE COMPARATOR

The patients in this group will receive 150 mg pregabalin tablets P.O 1 hours before surgery then after half hour morphine 0.1 mg/kg will be administered intramuscularly.

Drug: Pregabalin 150mg gabapentin 400mg

Group G

ACTIVE COMPARATOR

The patients in this group will receive 400 mg Gababentin4 tablets P.O 1 hours before surgery then after half hour morphine 0.1 mg/kg will be administered intramuscularly.

Drug: Pregabalin 150mg gabapentin 400mg

Group C

PLACEBO COMPARATOR

The patients in this group will receive vitamin B12 (100µg) as placebo tablets P.O hours before surgery then after half hour morphine 0.1 mg/kg will be administered intramuscularly.

Drug: Pregabalin 150mg gabapentin 400mg

Interventions

Pregabalin 150mg gabapentin 400mg DRUG

oral administration

Also known as: vitamin B12

Group C; Group G; Group P

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ASA I and ASA II
• Elective Lumber micro discectomy.
• BMI ≤ 35
• Time of operation not exceeding 2hours.

You may not qualify if:

• Patients' refusal
• Age \< 20 years or \> 60 years
• ASA III to ASA IV
• Contraindications to Opioids e.g., Allergy, Bronchial asthma.
• Contraindication to Pregabalin or Gabapentin e.g. Allergy
• Psychological or mental disorders.
• Disturbance of Conscious level.
• Uncooperative patients.
• Patients with impaired renal function or creatinine clearance less than 50ml/min

Sponsors & Collaborators

• Research Institute of Ophthalmology, Egypt: lead
• Cairo University: collaborator

Study Sites (1)

kasr el aini H

Giza, Egypt

Location

MeSH Terms

Interventions

Pregabalin; Gabapentin; Vitamin B 12

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Amines; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• mohamed s arafa, MD

  kasr el aini H

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2022
• First Posted: September 14, 2022
• Study Start: September 15, 2022
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: October 27, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)