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Completed

NCT Number: NCT03232957

Intrathecal Morphine for Unilateral Total Knee Arthroplasty

This study evaluates postoperative numerical pain score and systemic opioid requirement within 48 hours for unilateral total knee arthroplasty. Comparing among 3 groups of intrathecal morphine; 0,50, 100 ug with multimodal analgesia.

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Key information

Conditions

Primary Osteoarthritis of Knee Nos

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok Noi, Bangkok, 10700, Thailand

About this study

Intrathecal opioid is effective postoperative analgesia for orthopedic lower extremity surgery. However there are some limitations such as nausea, vomiting, pruritus, dizziness. Nowadays multimodal analgesia is used in unilateral total knee arthroplasty include oral analgesic drugs, adductor canal block and local analgesia infiltration.

This study evaluates whether intrathecal opioid should be added in the role of multimodal analgesia in total knee arthroplasty.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Aged more than 18 years old undergoing unilateral total knee arthroplasty
  • American Society of Anesthesiologists physical status classification 1-3

Exclusion criteria

  • Participants deny to enroll the study
  • Allergy to local anesthetics, opioid and NSAIDs
  • Hepatic disease
  • Contraindication for neuraxial block or adductor canal block
  • Uncontrolled cardiovascular disease
  • Creatinine clearance less than 50 ml/min

Treatment and study plan

50 ug IT morphine

Procedure

Spinal block with bupivacaine and intrathecal morphine 50 ug

100 ug IT morphine

Procedure

Spinal block with bupivacaine and intrathecal morphine 100 ug

No IT morphine

Procedure

Spinal block with bupivacaine and intrathecal morphine 0 ug

Morphine

Drug

intrathecal morphine

Bupivacaine

Drug

0.5 isobaric bupivacaine

Primary outcomes

  1. Numerical rating scale

    Time frame: Within 48 hours

    Numerical rating scale 0-10

Secondary outcomes

  1. Morphine requirement

    Time frame: Within 48 hours

    Systemic morphine requirement

  2. Nausea vomiting

    Time frame: Within 48 hours

    Incidence and severity of nausea and vomiting

  3. Pruritus

    Time frame: Within 48 hours

    Incidence and severity of pruritus

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

Efficacy and Side Effects of Intrathecal Morphine in Multimodal Analgesia for Unilateral Total Knee Arthroplasty

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 28, 2017
Registry last updated
May 24, 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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