Analgesia After Knee Arthroscopy :Dexmedetomidine vs Fentanyl

January 20, 2021 updated by: Dina Abdelhameed Elsadek Salem, Zagazig University

Comparative Study Between Dexmedetomidine and Fentanyl as an Adjuvant to Intra-articular Bupivacaine for Postoperative Analgesia After Knee Arthroscopy.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Forty-five patients ASA I - II aged 21-45 years for elective knee arthroscopy were divided into 3 groups: Group B, BD and BF. Group B received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 ml saline. Group BD received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 ml dexmedetomidine (100 ug).

Group BF received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 fentanyl (50 ug). The time of first request of analgesia and analgesic effect by VAS during the first 24 hr. postoperatively are recorded.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Zagazig, Egypt
        • Zagazig University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: group B
IGroup B received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 ml saline
Drug: Bupivacain
Group B received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 ml saline.
Other Names:
  • marcaine
Active Comparator: group BD
. Group BD received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 ml dexmedetomidine (100 ug).
Drug: Bupivacain
Group B received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 ml saline.
Other Names:
  • marcaine
Drug: Dexmedetomidine
Group BD received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 ml dexmedetomidine (100 ug).
Other Names:
  • precedex
Active Comparator: group BF
Group BF received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 fentanyl (50 ug).
Drug: Bupivacain
Group B received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 ml saline.
Other Names:
  • marcaine
Drug: Fentanyl
Group BF received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 fentanyl (50 ug)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of postoperative analgesia
Time Frame: For 24 hours postoperative
start from intra-articular injection of the drug to the time of first request of analgesia
For 24 hours postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
total dose of rescue analgesia ( pethidine)
Time Frame: within 24 hours postoperative
total consumption of rescue analgesia (pethidine) postoperative
within 24 hours postoperative
The number of participants with bradycardia, itching and hypotension
Time Frame: Within 24 hours postoperative
The number of participants with bradycardia less than 50 beat per minute, itching and hypotension if mean arterial blood pressure less than 20% of basal )
Within 24 hours postoperative
patient satisfaction
Time Frame: within 24 hours postoperative
Patient satisfaction by five point Likert-Like verbal rating scale by asking the patient how they evaluate the experience with the analgesic management after the the surgery? (5-very satisfied, 4-satisfied, 3-neutral, 2-dissatisfied, 1-very dissatisfied)
within 24 hours postoperative
pain intensity at rest (static)
Time Frame: measured immediately preoperative 0 minute ( admission receiving area)
measured by VAS on 0-10 cm scale (0- no pain and 10-the worst pain)
measured immediately preoperative 0 minute ( admission receiving area)
pain intensity at rest (static)
Time Frame: at 30 minutes postoperative
measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)
at 30 minutes postoperative
pain intensity at rest (static)
Time Frame: at 1 hour postoperative
measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)
at 1 hour postoperative
pain intensity at rest (static)
Time Frame: at 2 hours postoperative
measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)
at 2 hours postoperative
pain intensity at rest (static)
Time Frame: at 4 hours postoperative
measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)
at 4 hours postoperative
pain intensity at rest (static)
Time Frame: at 6 hours postoperative
measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)
at 6 hours postoperative
pain intensity at rest (static)
Time Frame: at 8 hours postoperative
measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)
at 8 hours postoperative
pain intensity at rest (static)
Time Frame: at 12 hours postoperative
measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)
at 12 hours postoperative
pain intensity at rest (static)
Time Frame: at 18 hours postoperative
measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)
at 18 hours postoperative
pain intensity at rest (static)
Time Frame: at 24 hours postoperative
measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)
at 24 hours postoperative
pain intensity on mobilization of operated knee (dynamic)
Time Frame: measured immediately preoperative 0 minute ( admission receiving area)
measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)
measured immediately preoperative 0 minute ( admission receiving area)
pain intensity on mobilization of operated knee (dynamic)
Time Frame: at 30 minutes postoperative
measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)
at 30 minutes postoperative
pain intensity on mobilization of operated knee (dynamic)
Time Frame: at 1 hours postoperative
measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)
at 1 hours postoperative
pain intensity on mobilization of operated knee (dynamic)
Time Frame: at 2 hours postoperative
measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)
at 2 hours postoperative
pain intensity on mobilization of operated knee (dynamic)
Time Frame: at 4 hours postoperative
measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)
at 4 hours postoperative
pain intensity on mobilization of operated knee (dynamic)
Time Frame: at 6 hours postoperative
measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)
at 6 hours postoperative
pain intensity on mobilization of operated knee (dynamic)
Time Frame: at 8 hours postoperative
measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)
at 8 hours postoperative
pain intensity on mobilization of operated knee (dynamic)
Time Frame: at 12 hours postoperative
measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)
at 12 hours postoperative
pain intensity on mobilization of operated knee (dynamic)
Time Frame: at 18 hours postoperative
measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)
at 18 hours postoperative
pain intensity on mobilization of operated knee (dynamic)
Time Frame: at 24 hours postoperative
measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)
at 24 hours postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zagazig University

Investigators

  • Principal Investigator: Dina Salem, MD., Faculty of Medicine , Zagazig University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2020

Primary Completion (Actual)

November 1, 2020

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

June 19, 2020

First Submitted That Met QC Criteria

June 20, 2020

First Posted (Actual)

June 23, 2020

Study Record Updates

Last Update Posted (Actual)

January 25, 2021

Last Update Submitted That Met QC Criteria

January 20, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5355

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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