Analgesia After Knee Arthroscopy :Dexmedetomidine vs Fentanyl

NCT ID: NCT04442906

Last Updated: 2021-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2020-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Analgesia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

analgesia for postoperative pain after knee arthroscopy: dexmedetomidine+bupivacaine, fentanyl+bupivacaine , bupivacaine
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
anesthetist not sharing in the study will assess patient

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

group B

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

Group Type ACTIVE_COMPARATOR

Bupivacain

Intervention Type DRUG

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

group BD

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

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

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

Bupivacain

Intervention Type DRUG

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

group BF

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

Group Type ACTIVE_COMPARATOR

Fentanyl

Intervention Type DRUG

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

Bupivacain

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dexmedetomidine

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

Intervention Type DRUG

Fentanyl

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

Intervention Type DRUG

Bupivacain

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

precedex marcaine

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Zagazig University

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dina Abdelhameed Elsadek Salem

Principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Dina Salem, MD.

Role: PRINCIPAL_INVESTIGATOR

faculty of medicine , Zagazig University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Zagazig university

Zagazig, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 34704709 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

5355

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Spinal Analgesia in Labour Pain
NCT07332130 NOT_YET_RECRUITING PHASE1