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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03248648
Recruitment Status : Completed
First Posted : August 14, 2017
Last Update Posted : January 15, 2019
Sponsor:
Collaborators:
Ghada Mohammed AboelFadl
Abualauon Elbiblawy
Information provided by (Responsible Party):
Amani Hassan Abdel-Wahab, Assiut University

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

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Neostigmine Drug: ketamine Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Intra-articular Neostigmine Versus Ketamine for Postoperative Analgesia in Arthroscopic Knee Surgery
Actual Study Start Date : March 1, 2017
Actual Primary Completion Date : September 1, 2017
Actual Study Completion Date : December 1, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Drug: Neostigmine
patient receive 0.5mg/dose neostigmine +18ml 0.25%bupivacaine in a total volume of 20 ml.
Other Name: epistigmine

Active Comparator: 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.
Drug: ketamine
patient receive 0.5 mg/kg ketamine+18ml 0.25%bupivacaine in a total volume of 20 ml.
Other Name: Ketalar




Primary Outcome Measures :
  1. postoperative analgesic consumption [ Time Frame: 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 :
  1. Postoperative visual analogue pain scale (VAS) [ Time Frame: 36 hours postoperative ]
    assessment of each patient on his bed at inpatient ward every 4 hours over a 36-hour period



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03248648


Locations
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Egypt
Assiut university hospitals
Assiut, Assiut Governorate, Egypt, Egypt, 715715
Sponsors and Collaborators
Assiut University
Ghada Mohammed AboelFadl
Abualauon Elbiblawy
Investigators
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Principal Investigator: Abualauon Elbiplaoy, lectural of anesthesia Assiut University
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Responsible Party: Amani Hassan Abdel-Wahab, MD, Assiut University
ClinicalTrials.gov Identifier: NCT03248648    
Other Study ID Numbers: IRB00008788
First Posted: August 14, 2017    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Ketamine
Neostigmine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinesterase Inhibitors
Enzyme Inhibitors
Cholinergic Agents
Parasympathomimetics
Autonomic Agents