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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04790292
• Other study ID #: FMASU MS 20/2020
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2020
• Est. completion date: August 1, 2020

Study information

• Verified date: March 2021
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 1, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Minimum Age: 18 years Maximum Age: 65 years Sex: Both Gender Based: No Accepts Healthy Volunteers: No

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)

Related Conditions & MeSH terms

• Anesthesia

Intervention

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

Locations

Country	Name	City	State
Egypt	Ain Shams University Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rescue analgesia time	Time to first analgesia requirement (considering the extubation is zero time)	first 24 hours post operative
Secondary	Total analgesic consumption	intramuscular diclofenac sodium 75mg will be given as rescue analgesic when VAS = 4. Total diclofenac consumption will be recorded	first 24 hours post operative