Intrathecal Morphine for Unilateral Total Knee Arthroplasty

Primary Osteoarthritis of Knee Nos Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03232957
• Other study ID #: Si 331/2017
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: July 31, 2019

Study information

• Verified date: May 2021
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: July 31, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis, Knee
• Primary Osteoarthritis of Knee Nos

Intervention

Procedure:
• 50 ug IT morphine
Spinal block with bupivacaine and intrathecal morphine 50 ug
• 100 ug IT morphine
Spinal block with bupivacaine and intrathecal morphine 100 ug
• No IT morphine
Spinal block with bupivacaine and intrathecal morphine 0 ug

Drug:
• Morphine
intrathecal morphine
• Bupivacaine
0.5 isobaric bupivacaine

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Siriraj Hospital, Mahidol University	Bangkok Noi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (7)

Hassett P, Ansari B, Gnanamoorthy P, Kinirons B, Laffey JG. Determination Of The Efficacy And Side-effect Profile Of Lower Doses Of Intrathecal Morphine In Patients Undergoing Total Knee Arthroplasty. BMC Anesthesiol. 2008 Sep 24;8:5. doi: 10.1186/1471-2253-8-5. — View Citation

Ibrahim MS, Alazzawi S, Nizam I, Haddad FS. An evidence-based review of enhanced recovery interventions in knee replacement surgery. Ann R Coll Surg Engl. 2013 Sep;95(6):386-9. doi: 10.1308/003588413X13629960046435. Review. — View Citation

Kunopart M, Chanthong P, Thongpolswat N, Intiyanaravut T, Pethuahong C. Effects of single shot femoral nerve block combined with intrathecal morphine for postoperative analgesia: a randomized, controlled, dose-ranging study after total knee arthroplasty. J Med Assoc Thai. 2014 Feb;97(2):195-202. — View Citation

McCartney CJ, Nelligan K. Postoperative pain management after total knee arthroplasty in elderly patients: treatment options. Drugs Aging. 2014 Feb;31(2):83-91. doi: 10.1007/s40266-013-0148-y. Review. — View Citation

Nakai T, Tamaki M, Nakamura T, Nakai T, Onishi A, Hashimoto K. Controlling pain after total knee arthroplasty using a multimodal protocol with local periarticular injections. J Orthop. 2013 Mar 17;10(2):92-4. doi: 10.1016/j.jor.2013.02.001. eCollection 2013. — View Citation

Rathmell JP, Pino CA, Taylor R, Patrin T, Viani BA. Intrathecal morphine for postoperative analgesia: a randomized, controlled, dose-ranging study after hip and knee arthroplasty. Anesth Analg. 2003 Nov;97(5):1452-7. — View Citation

Stowers MD, Lemanu DP, Coleman B, Hill AG, Munro JT. Review article: Perioperative care in enhanced recovery for total hip and knee arthroplasty. J Orthop Surg (Hong Kong). 2014 Dec;22(3):383-92. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numerical rating scale	Numerical rating scale 0-10	Within 48 hours
Secondary	Morphine requirement	Systemic morphine requirement	Within 48 hours
Secondary	Nausea vomiting	Incidence and severity of nausea and vomiting	Within 48 hours
Secondary	Pruritus	Incidence and severity of pruritus	Within 48 hours