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

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Neostigmine
ketamine
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Assiut university hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Neostigmine group

ketamine group

Arm Description

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

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

Outcomes

Primary Outcome Measures

postoperative analgesic consumption
assessment of each patient on his bed at inpatient ward every 4 hours over a 36-hour period

Secondary Outcome Measures

Postoperative visual analogue pain scale (VAS)
assessment of each patient on his bed at inpatient ward every 4 hours over a 36-hour period

Full Information

First Posted
August 10, 2017
Last Updated
January 12, 2019
Sponsor
Assiut University
Collaborators
Ghada Mohammed AboelFadl, Abualauon Elbiblawy
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1. Study Identification

Unique Protocol Identification Number
NCT03248648
Brief Title
Efficacy of Intra-articular Neostigmine Versus Ketamine for Postoperative Analgesia in Arthroscopic Knee Surgery
Official Title
Efficacy of Intra-articular Neostigmine Versus Ketamine for Postoperative Analgesia in Arthroscopic Knee Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
September 1, 2017 (Actual)
Study Completion Date
December 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
Collaborators
Ghada Mohammed AboelFadl, Abualauon Elbiblawy

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neostigmine group
Arm Type
Active Comparator
Arm Description
At the end of the surgery patients receive 0.5mg/dose neostigmine +18ml 0.25%bupivacaine in a total volume of 20 ml.
Arm Title
ketamine group
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Neostigmine
Other Intervention Name(s)
epistigmine
Intervention Description
patient receive 0.5mg/dose neostigmine +18ml 0.25%bupivacaine in a total volume of 20 ml.
Intervention Type
Drug
Intervention Name(s)
ketamine
Other Intervention Name(s)
Ketalar
Intervention Description
patient receive 0.5 mg/kg ketamine+18ml 0.25%bupivacaine in a total volume of 20 ml.
Primary Outcome Measure Information:
Title
postoperative analgesic consumption
Description
assessment of each patient on his bed at inpatient ward every 4 hours over a 36-hour period
Time Frame
36 hours postoperative the total consumption of analgesics in the first 36h postoperative
Secondary Outcome Measure Information:
Title
Postoperative visual analogue pain scale (VAS)
Description
assessment of each patient on his bed at inpatient ward every 4 hours over a 36-hour period
Time Frame
36 hours postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abualauon Elbiplaoy, lectural of anesthesia
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assiut university hospitals
City
Assiut
State/Province
Assiut Governorate
ZIP/Postal Code
Egypt, 715715
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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