Skip to main content
Clinical Trials/NCT03212495
NCT03212495CompletedPhase 2

Comparison Between Intra-articular Dexmedetomidine and Neostigmine as Adjuvant Analgesics After Knee Arthroscopy

Assiut University1 site in 1 country100 target enrollmentStarted: August 1, 2017Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
100
Locations
1
Primary Endpoint
postoperative pain

Study Overview

Brief Summary

Knee arthroscopy is a minimally invasive day case procedure which may be done for diagnosis, meniscectomy or debridement. Arthroscopic surgery is associated with a variable degree of postoperative pain, which is caused by an irritation of free nerve endings of the synovial tissue, anterior fat pad, and joint capsule due to surgical excision and resection

Detailed Description

Many studies were done using different intra-articular agents as local anesthetics, opioids, ketamine and alfa2- adrenergic agonists for prevention and treatment of pain after knee surgeries.

Dexmedetomidine is a potent and highly selective alfa2-adrenoreceptor agonist. It has sedative-hypnotic, anxiolytic, analgesic, anesthetic and sympatholytic effects. Intra-articular dexmedetomidine was used in several studies to enhance postoperative analgesia after knee arthroscopy with an increased time to first analgesic request and a decreased need for postoperative analgesia Neostigmine is an anticholinesterase and also has antinociceptive effects when administered intrathecally or peripherally.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Care Provider)

Masking Description

, Patients were randomly allocated (using random table assignment) into two groups to receive one of the following intra-articular solutions (prepared by an individual not involved in the study) which were injected into the knee joint through the cannular sheath after withdrawal of camera, by the orthopaedic surgeon (who was also unaware of the nature of the study drugs) before the arthroscope removed.

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • patients aged above 18 years
  • scheduled for elective arthroscopic knee surgery under intrathecal anaesthesia

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 alfa methyldopa, clonidine or beta adrenergic blockers were excluded from the study.

Arms & Interventions

dexmedetomidine (D group)

Active Comparator

intraarticular administration of dexmedetomidine at the end of surgery

Intervention: dexamedetomidine (Drug)

neostigmine (N group)

Active Comparator

intraarticular administration of neostigmine at the end of surgery.

Intervention: neostigmine (Drug)

Outcomes

Primary Outcomes

postoperative pain

Time Frame: 36 hours after the end of the surgery.

visual analogue pain scale

Secondary Outcomes

  • nausea,vomiting(36 hours after the end of the surgery.)
  • sedation(36 hours after the end of the surgery.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ghada Mohammed AboelFadl

Principal Investigator

Assiut University

Study Sites (1)

Loading locations...

Similar Trials