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Completed

NCT Number: NCT04790292

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

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.

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Key information

Conditions

Anesthesia

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ain Shams University Hospital

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

group M

Drug

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

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

Primary outcomes

  1. visual analogue score(VAS) at rest and movement

    Time frame: first 24 hours post operative

    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

Secondary outcomes

  1. Rescue analgesia time

    Time frame: first 24 hours post operative

    Time to first analgesia requirement (considering the extubation is zero time)

  2. Total analgesic consumption

    Time frame: first 24 hours post operative

    intramuscular diclofenac sodium 75mg will be given as rescue analgesic when VAS ≥ 4. Total diclofenac consumption will be recorded

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 10, 2021
Registry last updated
Mar 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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