Preemptive Oral Gabapentin and Tramadol on Postoperative Pain After Knee Arthroscopy

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06112223
• Other study ID #: 36264PR151/3/23
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 10, 2023
• Est. completion date: May 1, 2024

Study information

• Verified date: October 2023
• Source: Tanta University
• Contact: Laila A El-Ahwal, MD
• Phone: 00201018484319
• Email: lailaelahwal[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Gabapentin
Patients will receive oral gabapentin 600 mg 1 hour before the surgery.
• Tramadol
Patients will receive oral tramadol 100 mg 1 hour before the surgery.

Locations

Country	Name	City	State
Egypt	Tanta University	Tanta	El-Gharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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