The Effect of Gabapentin on Spinal Anesthesia Duration

NCT05659810 | Completed Early Phase 1

• 1 other identifier: R 177/2022
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective parallel group double blinded randomized study will be conducted over 60 adult participants between 20 and 60 years ASA (American Association of Anesthesiologists) I and II. The participants will be randomly allocated in 2 groups. Group A will receive 900 mg of gabapentin before surgery in 2 divided doses; 300 mg 10 hours prior to surgery and 600 mg 2 hours before surgery, while group B will receive 2 placebo tablets at the same time. The participants will receive spinal anesthesia in the form of 3ml of hyperbaric bupivacaine 0.5%. Hemodynamics will be recorded every 15 minutes till the end of surgery. Sensory, and motor block progression, and regression will be recorded also.

Conditions

Prolongation of Spinal Anesthesia

Keywords

Gabapentin, Spinal, Anesthesia, Visual analogue scale

Outcome Measures

Primary Outcomes (2)

• Measurement of the time of regression of sensory block

  Measurement of the time of regression of sensory block by using pin prick test

  4 hours

• Measurement of time of regression of motor block

  Measurement of time of regression of motor block by using Bromage scale from 0-4

  4 hours

Secondary Outcomes (2)

• Measurement of time to onset of sensory block

  15 minutes

• Measurement of duration of postoperative analgesia

  12 hours

Other Outcomes (1)

• Amount of postoperative analgesics required

  24 hours

Study Arms (2)

Preoperative oral gabapentin before spinal anesthesia

ACTIVE COMPARATOR

The participants will receive 900 mg of gabapentin before surgery in 2 divided doses; 300 mg 10 hours prior to surgery and 600 mg 2 hours before surgery.

Drug: Gabapentin 300mg

Preoperative oral placebo before spinal anesthesia

PLACEBO COMPARATOR

The participants will receive 1 tablet 10 hours prior to surgery, and then 2 tablets 2 hours prior to surgery

Drug: Gabapentin 300mg

Interventions

Gabapentin 300mg DRUG

Preoperative gabapentin before spinal anesthesia

Also known as: placebo tablet

Preoperative oral gabapentin before spinal anesthesia; Preoperative oral placebo before spinal anesthesia

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesiologists class I, and II
• Age 20 - 60 years
• Weight between 60 and 80 kilograms
• Height between 160 and 180 centimetres

You may not qualify if:

• Participants with contraindications to spinal anesthesia.
• Participant refusal
• Extreme short or tall statures
• Body mass index above 40

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams university hospitals

Cairo, 11566, Egypt

Location

MeSH Terms

Interventions

Gabapentin

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Ain Shams

  University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: A physician assessing outcomes blinded to the nature of the study and will monitor the block density and regression time. Drugs will be given to the patient by an anesthesiologist unaware of the study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia

Model Details: Randomization by concealed envelope method

Study Record Dates

• First Submitted: November 23, 2022
• First Posted: December 21, 2022
• Study Start: December 26, 2022
• Primary Completion: March 28, 2023
• Study Completion: April 10, 2023
• Last Updated: April 28, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)