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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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01312415
Enrollment
42
Registered
2011-03-10
Start date
2010-08-31
Completion date
2011-06-30
Last updated
2011-03-10

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

Conditions

Total Knee Replacement

Keywords

total knee arthroplasty, total knee replacement, local infiltration analgesia, intra-articular local anaesthesia, patients undergoing total knee arthroplasty (total knee replacement)

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.

Interventions

DRUGLevobupivacaine

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.

DRUGIntrathecal morphine

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).

Sponsors

Cork University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients scheduled for unilateral total knee replacement * Consent to spinal anaesthesia * ASA Grade I to III

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
Quality of analgesia in the postoperative period as assessed by visual analogue score (VAS) for pain at rest and on movement24 hours postoperatively

Secondary

MeasureTime frame
Opioid consumption in total in the first 48 hours postoperatively48 hours postoperatively

Countries

Ireland

Contacts

Primary ContactDenise M McCarthy, MB FCARCSI
dmc_btown@yahoo.co.uk353-87-2341254
Backup ContactGabriella Iohom, MB PhD
iohom@hotmail.com353-21-4922135

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026