Intra-articular Dexmedetomidine Versus Neostigmine After Knee Arthroscopy (a Comparative Study)

Knee Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03212495
• Other study ID #: dexmedetomidine vs neostigmine
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 7, 2017
• Last updated: January 10, 2018
• Start date: August 1, 2017
• Est. completion date: December 1, 2017

Study information

• Verified date: January 2018
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 1, 2017
• Est. primary completion date: November 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Knee Injuries

Intervention

Drug:
• dexamedetomidine
intraarticular injection of 1µg/kg dexametomidine +18ml 0.25%bubivacaine in a total volume of 20 ml.
• neostigmine
intraarticular injection of 0.5mg/dose neostigmine +18ml 0.25%bubivacaine in a total volume of 20 ml.

Locations

Country	Name	City	State
Egypt	Assiut governorate	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Al-Metwalli RR, Mowafi HA, Ismail SA, Siddiqui AK, Al-Ghamdi AM, Shafi MA, El-Saleh AR. Effect of intra-articular dexmedetomidine on postoperative analgesia after arthroscopic knee surgery. Br J Anaesth. 2008 Sep;101(3):395-9. doi: 10.1093/bja/aen184. Epu — View Citation

Bondok RS, Abd El-Hady AM. Intra-articular magnesium is effective for postoperative analgesia in arthroscopic knee surgery. Br J Anaesth. 2006 Sep;97(3):389-92. Epub 2006 Jul 11. — View Citation

Ebert T, Maze M. Dexmedetomidine: another arrow for the clinician's quiver. Anesthesiology. 2004 Sep;101(3):568-70. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative pain	visual analogue pain scale	36 hours after the end of the surgery.
Secondary	nausea,vomiting	nausea and vomiting scales	36 hours after the end of the surgery.
Secondary	sedation	Ramsay sedation score	36 hours after the end of the surgery.