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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06112223
Enrollment
50
Registered
2023-11-01
Start date
2023-04-01
Completion date
2023-09-01
Last updated
2024-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gabapentin, Knee Arthroscopy, Postoperative Pain, Spinal Anesthesia, Tramadol

Brief summary

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

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

Interventions

DRUGGabapentin

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

DRUGTramadol

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

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The intensity of postoperative pain24 hours postoperativelyAssessment 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

MeasureTime frameDescription
The total amount of morphine consumption in the first 24-hour postoperative24 hours postoperativelyRescue analgesia in the form of 3 mg of IV morphine will be given if the visual analog scale (VAS) score\> 3.
The time first rescue analgesia24 hours postoperativelyRescue analgesia in the form of 3 mg of IV morphine will be given if the visual analog scale (VAS) score≥ 4.
The incidence of side effects24 hours postoperativelyAny undesirable side effects during the first 24 hours will be recorded such as as nausea, vomiting &hypotension.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026