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NCT Number: NCT06112223

Preemptive Oral Gabapentin and Tramadol on Postoperative Pain After Knee Arthroscopy

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

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Key information

Conditions

Gabapentin Knee Arthroscopy Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Signs and Symptoms Spinal Anesthesia Tramadol

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gabapentin

Drug

Patients will receive oral gabapentin 600 mg 1 hour before the surgery.

Tramadol

Drug

Patients will receive oral tramadol 100 mg 1 hour before the surgery.

Primary outcomes

  1. The intensity of postoperative pain

    Time frame: 24 hours postoperatively

    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.

Secondary outcomes

  1. The total amount of morphine consumption in the first 24-hour postoperative

    Time frame: 24 hours postoperatively

    Rescue analgesia in the form of 3 mg of IV morphine will be given if the visual analog scale (VAS) score> 3.

  2. The time first rescue analgesia

    Time frame: 24 hours postoperatively

    Rescue analgesia in the form of 3 mg of IV morphine will be given if the visual analog scale (VAS) score≥ 4.

  3. The incidence of side effects

    Time frame: 24 hours postoperatively

    Any undesirable side effects during the first 24 hours will be recorded such as as nausea, vomiting &hypotension.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Nov 1, 2023
Registry last updated
Oct 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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