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

NCT ID: NCT03248648

Last Updated: 2019-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2017-12-01

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.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Neostigmine group

At the end of the surgery patients receive 0.5mg/dose neostigmine +18ml 0.25%bupivacaine in a total volume of 20 ml.

Group Type: ACTIVE_COMPARATOR

Neostigmine

Intervention Type: DRUG

patient receive 0.5mg/dose neostigmine +18ml 0.25%bupivacaine in a total volume of 20 ml.

ketamine group

At the end of the surgery patients receive 0.5 mg/kg ketamine+18ml 0.25%bupivacaine in a total volume of 20 ml.

Group Type: ACTIVE_COMPARATOR

ketamine

Intervention Type: DRUG

patient receive 0.5 mg/kg ketamine+18ml 0.25%bupivacaine in a total volume of 20 ml.

Interventions

Neostigmine

patient receive 0.5mg/dose neostigmine +18ml 0.25%bupivacaine in a total volume of 20 ml.

Intervention Type: DRUG

ketamine

patient receive 0.5 mg/kg ketamine+18ml 0.25%bupivacaine in a total volume of 20 ml.

Intervention Type: DRUG

Other Intervention Names

epistigmine; Ketalar

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ghada Mohammed AboelFadl

UNKNOWN

Sponsor Role: collaborator

Abualauon Elbiblawy

UNKNOWN

Sponsor Role: collaborator

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Amani Hassan Abdel-Wahab

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Abualauon Elbiplaoy, lectural of anesthesia

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

Assiut university hospitals

Asyut, Assiut Governorate, Egypt

Countries

Egypt

Other Identifiers

IRB00008788

Identifier Type: -

Identifier Source: org_study_id