The Analgesic Efficacy of Local Anaesthetic Wound Infiltration Versus Intrathecal Morphine for Total Knee Replacement

Total Knee Replacement Clinical Trial

Official title:

A Comparison of the Analgesic Efficacy of Local Anaesthetic Wound Infiltration Versus Intrathecal Morphine for Total Knee Replacement

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01312415
• Other study ID #: TKR-SMOH
• Status: Recruiting
• Phase: Phase 4
• First received: March 9, 2011
• Last updated: March 9, 2011
• Start date: August 2010
• Est. completion date: June 2011

Study information

• Verified date: March 2011
• Source: Cork University Hospital
• Contact: Denise M McCarthy, MB FCARCSI
• Phone: 353-87-2341254
• Email: dmc_btown[@]yahoo.co.uk
• Is FDA regulated: No
• Health authority: Ireland: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Total Knee Replacement

Intervention

Drug:
• Levobupivacaine
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.
• Intrathecal 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).

Locations

Country	Name	City	State
Ireland	St Mary Orthopedic Hospital	Cork

Sponsors (1)

Lead Sponsor	Collaborator
Cork University Hospital

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of analgesia in the postoperative period as assessed by visual analogue score (VAS) for pain at rest and on movement		24 hours postoperatively	No
Secondary	Opioid consumption in total in the first 48 hours postoperatively		48 hours postoperatively	No