Analgesia After Knee Arthroscopy :Dexmedetomidine vs Fentanyl

NCT04442906 | Completed

• 1 other identifier: 5355
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate analgesic effects Bupivacaine, Bupivacaine plus Dexmedetomidine and Bupivacaine plus Fentanyl in relieving pain after knee arthroscopic surgery.

Conditions

Analgesia

Keywords

dexmedetomidine; fentanyl; bupivacaine; knee arthroscopy; postoperative analgesia

Outcome Measures

Primary Outcomes (1)

• Duration of postoperative analgesia

  start from intra-articular injection of the drug to the time of first request of analgesia

  For 24 hours postoperative

Secondary Outcomes (23)

• total dose of rescue analgesia ( pethidine)

  within 24 hours postoperative

• The number of participants with bradycardia, itching and hypotension

  Within 24 hours postoperative

• patient satisfaction

  within 24 hours postoperative

• pain intensity at rest (static)

  measured immediately preoperative 0 minute ( admission receiving area)

• pain intensity at rest (static)

  at 30 minutes postoperative

Study Arms (3)

group B

ACTIVE COMPARATOR

IGroup B received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 ml saline

Drug: Bupivacain

group BD

ACTIVE COMPARATOR

. Group BD received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 ml dexmedetomidine (100 ug).

Drug: Dexmedetomidine; Drug: Bupivacain

group BF

ACTIVE COMPARATOR

Group BF received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 fentanyl (50 ug).

Drug: Fentanyl; Drug: Bupivacain

Interventions

Dexmedetomidine DRUG

Group BD received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 ml dexmedetomidine (100 ug).

Also known as: precedex

group BD

Fentanyl DRUG

Group BF received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 fentanyl (50 ug)

group BF

Bupivacain DRUG

Group B received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 ml saline.

Also known as: marcaine

group B; group BD; group BF

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Either sex,
• Age 21-45 years,
• American Society of Anesthesia (ASA) I - II for elective knee arthroscopy.

You may not qualify if:

• The patients with history of hepatic and renal diseases, psychiatric disorders,
• Prolonged intake of (NSAIDS, opioids and tricyclic antidepressant),
• Allergy to study drugs and patient who received analgesics up to 24 hr. before surgery were excluded from this study.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig university

Zagazig, Egypt

Location

Related Publications (1)

• Salem DAE, Nabi SMA, Alagamy SA, Kamel AAF. Comparative Study Between Dexmedetomidine and Fentanyl as an Adjuvant to Intraarticular Bupivacaine for Postoperative Analgesia after Knee Arthroscopy. Pain Physician. 2021 Nov;24(7):E989-E996.

  PMID: 34704709 DERIVED

MeSH Terms

Conditions

Agnosia

Interventions

Dexmedetomidine; Fentanyl; Bupivacaine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperidines; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Dina Salem, MD.

  faculty of medicine , Zagazig University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: anesthetist not sharing in the study will assess patient
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Model Details: analgesia for postoperative pain after knee arthroscopy: dexmedetomidine+bupivacaine, fentanyl+bupivacaine , bupivacaine

Study Record Dates

• First Submitted: June 19, 2020
• First Posted: June 23, 2020
• Study Start: July 1, 2020
• Primary Completion: November 1, 2020
• Study Completion: December 1, 2020
• Last Updated: January 25, 2021

Record last verified: 2021-01

Locations

EG (1)