Preemptive Oral Gabapentin and Tramadol on Postoperative Pain After Knee Arthroscopy

Preemptive Oral Gabapentin Versus Tramadol on Postoperative Pain After Knee Arthroscopy Done Under Spinal Anesthesia: A Prospective Randomized Trial

The aim of this study to evaluate the effect of preemptive oral gabapentin versus tramadol on postoperative pain after knee arthroscopy under spinal anesthesia.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Spinal Anesthesia; Knee Arthroscopy; Gabapentin; Tramadol
• Intervention / Treatment: Drug: Gabapentin; Drug: Tramadol

Detailed Description

Orthopedic surgeries are frequently associated with moderate-to-severe postoperative pain that can decrease mobility in the immediate postoperative period, interfere with postoperative rehabilitation, and delay hospital discharge. Pain may also become chronic.

Spinal anesthesia is the most popular anesthesia technique worldwide in orthopedic lower limb surgeries. However, its relatively short duration of action may limit the excellent postoperative analgesic effect. Thus, many adjuvants had been used to improve postoperative analgesia and decrease consumption of postoperative analgesics.

Gabapentin is a gamma aminobutyric acid analogue that is known as an anticonvulsant drug. This drug is tolerated well and has known effects on pain and anxiety.

Tramadol, a commonly used postoperative analgesic, is a synthetic centrally acting opioid analgesic. The various actions include inhibition of noradrenaline and serotonin reuptake, and also inhibition of M1 and M3 muscarinic receptors

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31527
      • Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18-65 years old.
• Both sexes. American Society of Anesthesiologists (ASA) physical status I and II
• Undergoing knee arthroscopy procedures.
• under spinal anesthesia.

Exclusion Criteria:

• Cardiac patients.
• Patients with known allergy to drug of study.
• Prolonged administration of NSAIDS or other analgesics due to chronic pain of any reason.
• Cirrhosis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gabapentin; Patients will receive oral gabapentin 600 mg 1 hour before the surgery.	Drug: Gabapentin; Patients will receive oral gabapentin 600 mg 1 hour before the surgery.
Experimental: Tramadol; Patients will receive oral tramadol 100 mg 1 hour before the surgery.	Drug: Tramadol; Patients will receive oral tramadol 100 mg 1 hour before the surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The intensity of postoperative pain	Assessment of postoperative pain will be done with a analogue scale (VAS; 0=no pain and 10=worst possible pain). At discharge post-operative and every 2 hours postoperative till 12hours then every 6 hours for the first 24 hours.	24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The total amount of morphine consumption in the first 24-hour postoperative	Rescue analgesia in the form of 3 mg of IV morphine will be given if the visual analog scale (VAS) score> 3.	24 hours postoperatively
The time first rescue analgesia	Rescue analgesia in the form of 3 mg of IV morphine will be given if the visual analog scale (VAS) score≥ 4.	24 hours postoperatively
The incidence of side effects	Any undesirable side effects during the first 24 hours will be recorded such as as nausea, vomiting &hypotension.	24 hours postoperatively

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Actual): September 1, 2023
• Study Completion (Actual): September 1, 2023

Study Registration Dates

• First Submitted: October 26, 2023
• First Submitted That Met QC Criteria: October 26, 2023
• First Posted (Actual): November 1, 2023

Study Record Updates

• Last Update Posted (Actual): October 2, 2024
• Last Update Submitted That Met QC Criteria: October 1, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Analgesics, Opioid; Narcotics; Tranquilizing Agents; Psychotropic Drugs; Anti-Anxiety Agents; Anticonvulsants; Antimanic Agents; Gabapentin; Tramadol
• Other Study ID Numbers: 36264PR151/3/23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No