The Analgesic Efficacy of Local Anaesthetic Wound Infiltration Versus Intrathecal Morphine for Total Knee Replacement
A Comparison of the Analgesic Efficacy of Local Anaesthetic Wound Infiltration Versus Intrathecal Morphine for Total Knee Replacement
1 other identifier
interventional
42
1 country
1
Brief Summary
Total knee replacement (TKR) is associated postoperatively with considerable pain and analgesic requirement. Total knee replacement is routinely performed under spinal anaesthesia with intrathecal bupivacaine plus preservative free morphine. We hypothesize that infiltration of the surgical site with peri- and intraarticular levobupivacaine local anaesthetic would be an efficacious pain management technique and would not be inferior to intrathecal morphine for postoperative pain management. We further hypothesize that the use of this surgical site infiltration technique would decrease post-operative systemic opioid requirements as well as the side effects associated with intrathecal and systemic opioids.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Aug 2010
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 9, 2011
CompletedFirst Posted
Study publicly available on registry
March 10, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedMarch 10, 2011
March 1, 2011
10 months
March 9, 2011
March 9, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Quality of analgesia in the postoperative period as assessed by visual analogue score (VAS) for pain at rest and on movement
24 hours postoperatively
Secondary Outcomes (1)
Opioid consumption in total in the first 48 hours postoperatively
48 hours postoperatively
Study Arms (2)
levobupivacaine infiltration
EXPERIMENTALPatients will receive spinal anaesthesia with intrathecal bupivacaine (17.5 or 15 mg) without morphine, and will receive peri- and intraarticular surgical site infiltration before wound closure with a solution of levobupivacaine 0.5% 2mg/kg body weight (maximum 200mg levobupivacaine) plus 0.5mg epinephrine made up to 100ml with saline. An intra-articular catheter will be placed by the surgeon before closure under the sterile surgical conditions and this will be left in situ in the wound. The patient will receive one further injection of 15ml of levobupivacaine 0.5% at 8am the following morning.
Control
OTHERPatients will receive spinal anaesthesia with intrathecal bupivacaine 0.5% (17.5 mg if greater than 70 kg and 15 mg if less than 70 kg) and preservative-free morphine (0.3 mg).
Interventions
Patients will receive peri- and intraarticular surgical site infiltration to the knee during surgery and before wound closure with a solution of levobupivacaine 0.5% 2mg/kg body weight (maximum 200mg levobupivacaine will be used if the patient's weight exceeds 100kg) plus 0.5mg epinephrine made up to 100ml with saline. An intra-articular catheter will be placed by the surgeon before closure under the sterile surgical conditions and this will be left in situ in the wound. The patient will receive one further injection of 15ml of levobupivacaine 0.5% solution at 8am on the morning of the first postoperative day after which the catheter will be removed.
Patients will receive spinal anaesthesia with intrathecal bupivacaine 0.5% (17.5 mg if greater than 70 kg and 15 mg if less than 70 kg) and preservative-free morphine (0.3 mg).
Eligibility Criteria
You may qualify if:
- Patients scheduled for unilateral total knee replacement
- Consent to spinal anaesthesia
- ASA Grade I to III
You may not qualify if:
- Patient refusal
- Mini-Mental Score \< 25 (see appendix 3)
- Allergy to bupivacaine, morphine, paracetamol, diclofenac
- Skin lesions/infection at site of injection
- Uncorrected renal dysfunction
- Coagulation disorders
- chronic pain condition other than knee pain
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St Mary Orthopedic Hospital
Cork, Ireland
Related Publications (1)
McCarthy D, McNamara J, Galbraith J, Loughnane F, Shorten G, Iohom G. A comparison of the analgesic efficacy of local infiltration analgesia vs. intrathecal morphine after total knee replacement: A randomised controlled trial. Eur J Anaesthesiol. 2019 Apr;36(4):264-271. doi: 10.1097/EJA.0000000000000943.
PMID: 30640244DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Denise M McCarthy, MB FCARSCI
Cork University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 9, 2011
First Posted
March 10, 2011
Study Start
August 1, 2010
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
March 10, 2011
Record last verified: 2011-03