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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

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

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

NCT ID

NCT03248648

First Posted

August 10, 2017

Last Updated

January 12, 2019

Sponsor

Assiut University

Collaborators

Ghada Mohammed AboelFadl, Abualauon Elbiblawy

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

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

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

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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