Efficacy of Intra-articular Neostigmine Versus Ketamine for Postoperative Analgesia in Arthroscopic Knee Surgery

Phase 2

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: Neostigmine; Drug: ketamine

• Registration Number: NCT03248648
• Lead Sponsor: Assiut University

Brief Summary

To compare the efficacy of intra-articular administration of neostigmine versus ketamine as adjuvant analgesics after knee arthroscopy.

Detailed Description

Arthroscopic knee surgery is commonly performed as an outpatient procedure and is often associated with postoperative pain. Intraarticular (IA) local anesthetics (LA) are often used for prevention of pain after arthroscopic knee surgery; however, the degree of postoperative pain varies. In an effort to find the ideal regime for sufficient, long-lasting postoperative analgesia, many different drugs, including opioids, nonsteroidal anti-inflammatory drugs, ketamine, clonidine, and neostigmine, have been added to the IA LAs The investigators designed this study to compare the efficacy of intra-articular administration of neostigmine versus ketamine as adjuvant analgesics after knee arthroscopy.

Study Timeline

• Study Start: 2017-03-01
• Study First Submitted: 2017-08-10
• Study First Submitted QC: 2017-08-10
• Study First Posted: 2017-08-14
• Primary Completion: 2017-09-01
• Study Completion: 2017-12-01
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-12
• Last Update Posted: 2019-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• One hundred patients aged above 18-50 years (ASA I or II) scheduled for elective arthroscopic knee surgery under intrathecal anaesthesia will be enrolled in our study.

Exclusion Criteria

• Absolute or relative contraindications for intrathecal anaesthesia,
• Allergy for the studied drugs.
• Patients having history of cardiovascular, cerebrovascular, and respiratory diseases,
• Patients receiving chronic pain treatment or hypertension treated with α methyldopa, clonidine or β adrenergic blockers were excluded from the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neostigmine group	Neostigmine	At the end of the surgery patients receive 0.5mg/dose neostigmine +18ml 0.25%bupivacaine in a total volume of 20 ml.
ketamine group	ketamine	At the end of the surgery patients receive 0.5 mg/kg ketamine+18ml 0.25%bupivacaine in a total volume of 20 ml.

Primary Outcome Measures

Name	Time	Method
postoperative analgesic consumption	36 hours postoperative the total consumption of analgesics in the first 36h postoperative	assessment of each patient on his bed at inpatient ward every 4 hours over a 36-hour period

Secondary Outcome Measures

Name	Time	Method
Postoperative visual analogue pain scale (VAS)	36 hours postoperative	assessment of each patient on his bed at inpatient ward every 4 hours over a 36-hour period

Trial Locations

Locations (1)

Assiut university hospitals; 🇪🇬 Assiut, Assiut Governorate, Egypt