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

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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

Tracking Information
First Submitted Date  ICMJE August 10, 2017
First Posted Date  ICMJE August 14, 2017
Last Update Posted Date January 15, 2019
Actual Study Start Date  ICMJE March 1, 2017
Actual Primary Completion Date September 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 12, 2017)
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
Original Primary Outcome Measures  ICMJE
 (submitted: August 10, 2017)
postoperative analgesic consumption [ Time Frame: 36 hours postoperativ 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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 12, 2017)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2017)
Postoperative visual analogue pain scale (VAS) [ Time Frame: 36 hours postoperativ ]
assessment of each patient on his bed at inpatient ward every 4 hours over a 36-hour period
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Intra-articular Neostigmine Versus Ketamine for Postoperative Analgesia in Arthroscopic Knee Surgery
Official Title  ICMJE Efficacy of Intra-articular Neostigmine Versus Ketamine for Postoperative Analgesia in Arthroscopic Knee Surgery
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE 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
Condition  ICMJE Postoperative Pain
Intervention  ICMJE
  • Drug: Neostigmine
    patient receive 0.5mg/dose neostigmine +18ml 0.25%bupivacaine in a total volume of 20 ml.
    Other Name: epistigmine
  • Drug: ketamine
    patient receive 0.5 mg/kg ketamine+18ml 0.25%bupivacaine in a total volume of 20 ml.
    Other Name: Ketalar
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Neostigmine
  • 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.
    Intervention: Drug: ketamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 10, 2017)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 1, 2017
Actual Primary Completion Date September 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03248648
Other Study ID Numbers  ICMJE IRB00008788
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Amani Hassan Abdel-Wahab, Assiut University
Study Sponsor  ICMJE Assiut University
Collaborators  ICMJE
  • Ghada Mohammed AboelFadl
  • Abualauon Elbiblawy
Investigators  ICMJE
Principal Investigator: Abualauon Elbiplaoy, lectural of anesthesia Assiut University
PRS Account Assiut University
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP