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

NCT03248648 | Completed Phase 2 DMC

• 1 other identifier: IRB00008788
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Postoperative visual analogue pain scale (VAS)

  36 hours postoperative

Study Arms (2)

Neostigmine group

ACTIVE COMPARATOR

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

Drug: Neostigmine

ketamine group

ACTIVE COMPARATOR

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

Drug: ketamine

Interventions

Neostigmine DRUG

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

Also known as: epistigmine

Neostigmine group

ketamine DRUG

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

Also known as: Ketalar

ketamine group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead
• Ghada Mohammed AboelFadl: collaborator
• Abualauon Elbiblawy: collaborator

Study Sites (1)

Assiut university hospitals

Asyut, Assiut Governorate, Egypt, 715715, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Neostigmine; Ketamine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Abualauon Elbiplaoy, lectural of anesthesia

  Assiut University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 10, 2017
• First Posted: August 14, 2017
• Study Start: March 1, 2017
• Primary Completion: September 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 15, 2019

Record last verified: 2019-01

Locations

EG (1)