Intrathecal Morphine for Unilateral Total Knee Arthroplasty

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03232957

Enrollment

131

Registered

2017-07-28

Start date

2017-08-01

Completion date

2019-07-31

Last updated

2021-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Osteoarthritis of Knee Nos

Keywords

Intrathecal morphine, total knee arthroplasty

Brief summary

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.

Detailed description

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.

Interventions

PROCEDURE50 ug IT morphine

Spinal block with bupivacaine and intrathecal morphine 50 ug

PROCEDURE100 ug IT morphine

Spinal block with bupivacaine and intrathecal morphine 100 ug

PROCEDURENo IT morphine

Spinal block with bupivacaine and intrathecal morphine 0 ug

DRUGMorphine

intrathecal morphine

DRUGBupivacaine

0.5 isobaric bupivacaine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Masking description

In the anesthetic record, 0.5% isobaric bupivacaine with study drug is recorded.

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Numerical rating scale	Within 48 hours	Numerical rating scale 0-10

Secondary

Measure	Time frame	Description
Morphine requirement	Within 48 hours	Systemic morphine requirement
Nausea vomiting	Within 48 hours	Incidence and severity of nausea and vomiting
Pruritus	Within 48 hours	Incidence and severity of pruritus

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026