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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03248648
• Other study ID #: IRB00008788
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: March 1, 2017
• Est. completion date: December 1, 2017

Study information

• Verified date: January 2019
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 1, 2017
• Est. primary completion date: September 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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 a methyldopa, clonidine or ß adrenergic blockers were excluded from the study.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Neostigmine
patient receive 0.5mg/dose neostigmine +18ml 0.25%bupivacaine in a total volume of 20 ml.
• ketamine
patient receive 0.5 mg/kg ketamine+18ml 0.25%bupivacaine in a total volume of 20 ml.

Locations

Country	Name	City	State
Egypt	Assiut university hospitals	Assiut	Assiut Governorate

Sponsors (3)

Lead Sponsor	Collaborator
Assiut University	Abualauon Elbiblawy, Ghada Mohammed AboelFadl

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative analgesic consumption	assessment of each patient on his bed at inpatient ward every 4 hours over a 36-hour period	36 hours postoperative the total consumption of analgesics in the first 36h postoperative
Secondary	Postoperative visual analogue pain scale (VAS)	assessment of each patient on his bed at inpatient ward every 4 hours over a 36-hour period	36 hours postoperative