Preemptive Oral Gabapentin and Tramadol on Postoperative Pain After Knee Arthroscopy

Study Overview
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Brief Summary
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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
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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

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

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

Intervention / Treatment
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* Drug: Gabapentin
* Drug: Tramadol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gabapentin<br>Patients will receive oral gabapentin 600 mg 1 hour before the surgery. | Drug: Gabapentin<br>* Patients will receive oral gabapentin 600 mg 1 hour before the surgery.<br>|
| Experimental: Tramadol<br>Patients will receive oral tramadol 100 mg 1 hour before the surgery. | Drug: Tramadol<br>* Patients will receive oral tramadol 100 mg 1 hour before the surgery.<br>|

What is the study measuring?
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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 |