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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zagazig University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 19, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 23, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 25, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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