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Analgesic Effect Of Intra-articular Bupivacaine Fentanyl for Postoperative Pain Relief in Knee Arthroscopic Surgery

NCT ID: NCT03847792

Last Updated: 2020-09-11

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-31

Study Completion Date

2020-06-30

Brief Summary

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However, local anesthetic agents can produce analgesia for a limited time when used as a single injection. Bupivacaine is a local anesthetic that has an immediate action on pain by blocking peripheral afferents. However, as the ideal analgesic, the drug must cover the whole postoperative period (≥ 24 hours); therefore, bupivacaine is usually combined with many adjutants to provide long-lasting post-arthroscopy analgesia.

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Detailed Description

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Intr-articular drug administration has gained popularity because of its simplicity and efficacy in achieving anesthesia for diagnostic and operative arthroscopy and for providing postoperative analgesia .although the knee joint has been examined most commonly, arthroscopy of other joints such as shoulder, ankle, wrist, metatarsophalangeal and temporomandibular joints is being increasingly used.

Intra-articular installation of local anesthesia during arthroscopic procedures has been used by many orthopedic surgeons to provide pain relief after surgery.The aim of this study was to evaluate the analgesic efficacy of intra-articular dexamethasone versus fentanyl added as an adjuvant to bupivacaine in patients undergoing knee arthroscopic surgery

Conditions

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Knee Arthroscopic Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Group DB/Dexamethasone-Bupivacaine

Patients were received an intra-articular injection of 8mg dexamethasone added to18mL of 0.25% bupivacaine

Group Type ACTIVE_COMPARATOR

Group DB/Dexamethasone-Bupivacaine

Intervention Type DRUG

The patient were received an intra-articular injection of 18ml bupivacaine 0.25% added to 8mg dexamethasone.

Group FB /Fentanyl-Bupivacaine

Patients were received an intra-articular injection of 1 ug/kg fentanyl added to 18 mL of 0.25% bupivacaine

Group Type ACTIVE_COMPARATOR

Group FB /Fentanyl-Bupivacaine

Intervention Type DRUG

The patient were received an intra-articular injection of 1 ug/kg fentanyl added to 18ml of 0.25% bupivacaine.

Group PB/Placebo-Bupivacaine

Patients were received an intra-articular injection of 2 mL isotonic saline added to 18 mL of 0.25% bupivacaine

Group Type PLACEBO_COMPARATOR

Group PB/Placebo-Bupivacaine

Intervention Type DRUG

Patients were received an intra-articular injection of 2ml isotonic saline added to 18ml of 0.25% bupivacaine.

Interventions

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Group DB/Dexamethasone-Bupivacaine

The patient were received an intra-articular injection of 18ml bupivacaine 0.25% added to 8mg dexamethasone.

Intervention Type DRUG

Group FB /Fentanyl-Bupivacaine

The patient were received an intra-articular injection of 1 ug/kg fentanyl added to 18ml of 0.25% bupivacaine.

Intervention Type DRUG

Group PB/Placebo-Bupivacaine

Patients were received an intra-articular injection of 2ml isotonic saline added to 18ml of 0.25% bupivacaine.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* American Society of Anesthesiologists physical status (ASA) I or II

Exclusion Criteria

* Contraindication to spinal anesthesia.
* Allergy to the study drugs.
* Refusal of the patients.
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mohamed M Sultan, MD

Role: STUDY_CHAIR

Professor of Anaesthesia and Surgical Intensive Care

Hazem ESM Weheba, MD

Role: STUDY_DIRECTOR

Assistant Professor of Anaesthesia and Surgical Intensive Care

Hosam Ibrahim EL said saber, MD

Role: STUDY_DIRECTOR

Lecturer of Anaesthesia and Surgical Intensive Care

Locations

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Mohamed A Sultan

Al Mansurah, DK, Egypt

Site Status

Mansoura University

Al Mansurah, Eastern, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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MS/18.09.306

Identifier Type: -

Identifier Source: org_study_id

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