Impact of Dexamethasone Added to Intra-articular Morphine and Bupivacaine for Post-operative Analgesia After Knee Arthroscopy

NCT ID: NCT04790292

Last Updated: 2021-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2020-08-01

Brief Summary

A randomized double-blinded clinical trial was carried out on 40 patients undergoing knee arthroscopy. Patients were divided randomly into two equal groups. All drugs used were injected intra-articularly at the end of arthroscopy. In the control group, patients were administered 10mg morphine added to bupivacaine 25mg. In the study group, patients were administered 10mg morphine and 8mg dexamethasone added to bupivacaine 25mg. Visual analog score for pain at rest and movement, time to first analgesic request, total analgesic consumption, duration of analgesia and adverse effects were recorded.

Conditions

Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

group M

group M 10mg morphine +0.25% bupivacaine

Group Type: ACTIVE_COMPARATOR

group M

Intervention Type: DRUG

10mg morphine in 5ml normal saline + 10ml of 0.25% bupivacaine ( total volume 15 ml) were injected intra-articularly

group MD

group MD 10mg morphine + 8mg dexamethasone +0.25% bupivacaine

Group Type: ACTIVE_COMPARATOR

group MD

Intervention Type: DRUG

10mg morphine + 8mg dexamethasone completed to 5 ml with normal saline + 10 ml of 0.25% bupivacaine (total volume of 15ml) were injected intra-articularly

Interventions

group M

10mg morphine in 5ml normal saline + 10ml of 0.25% bupivacaine ( total volume 15 ml) were injected intra-articularly

Intervention Type: DRUG

group MD

10mg morphine + 8mg dexamethasone completed to 5 ml with normal saline + 10 ml of 0.25% bupivacaine (total volume of 15ml) were injected intra-articularly

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• American Society of Anesthesiologists (ASA) physical status I and II
• Scheduled for minor arthroscopic knee surgeries (meniscectomy, chondroplasty, minor ligament repair and diagnostic arthroscopy)

Exclusion Criteria

• American Society of Anesthesiologists (ASA) physical status above (II)
• Undergoing major knee surgeries
• History of allergies to any of the used drugs
• History of diabetes mellitus
• Contraindications of morphine use (e.g. asthmatic patient, chronic obstructive pulmonary disease, and addiction)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Heba Fouad Abd El-Aziz Toulan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Heba F Abd El-Aziz Toulan, MD

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

Ain Shams University Hospital

Cairo, , Egypt

Countries

Egypt

Other Identifiers

FMASU MS 20/2020

Identifier Type: -

Identifier Source: org_study_id