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

NCT04790292 | Completed Phase 4

• 1 other identifier: FMASU MS 20/2020
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Dexamethasone; Bupivacaine; Morphine

Outcome Measures

Primary Outcomes (1)

• visual analogue score(VAS) at rest and movement

  visual analogue score(VAS) will be used to measure pain score (VAS score 0 cm= no pain, VAS score 10 cm = worst possible pain) when the patient is fully conscious (0) and at 2, 4, 6, 8, 10, 12, 18, 24 hours post-operatively

  first 24 hours post operative

Secondary Outcomes (2)

• Rescue analgesia time

  first 24 hours post operative

• Total analgesic consumption

  first 24 hours post operative

Study Arms (2)

group M

ACTIVE COMPARATOR

group M 10mg morphine +0.25% bupivacaine

Drug: group M

group MD

ACTIVE COMPARATOR

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

Drug: group MD

Interventions

group M DRUG

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

group M

group MD 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

group MD

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospital

Cairo, Egypt

Location

Study Officials

• Heba F Abd El-Aziz Toulan, MD

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 10, 2021
• Study Start: January 1, 2020
• Primary Completion: July 1, 2020
• Study Completion: August 1, 2020
• Last Updated: March 16, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)