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

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.

Study Overview

• Status: Unknown
• Conditions: Total Knee Replacement
• Intervention / Treatment: Drug: Levobupivacaine; Drug: Intrathecal morphine

• Study Type: Interventional
• Enrollment (Anticipated): 42
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Denise M McCarthy, MB FCARCSI; Phone Number: 353-87-2341254; Email: dmc_btown@yahoo.co.uk
• Study Contact Backup: Name: Gabriella Iohom, MB PhD; Phone Number: 353-21-4922135; Email: iohom@hotmail.com

Study Locations

• Ireland
  • Cork, Ireland
    • Recruiting
    • St Mary Orthopedic Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: levobupivacaine infiltration; Patients 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.	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.
Other: Control; 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).	Drug: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Opioid consumption in total in the first 48 hours postoperatively	48 hours postoperatively

Collaborators and Investigators

• Sponsor: Cork University Hospital
• Investigators: Principal Investigator: Denise M McCarthy, MB FCARSCI, Cork University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Anticipated): June 1, 2011
• Study Completion (Anticipated): June 1, 2011

Study Registration Dates

• First Submitted: March 9, 2011
• First Submitted That Met QC Criteria: March 9, 2011
• First Posted (Estimate): March 10, 2011

Study Record Updates

• Last Update Posted (Estimate): March 10, 2011
• Last Update Submitted That Met QC Criteria: March 9, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: total knee replacement; total knee arthroplasty; local infiltration analgesia; intra-articular local anaesthesia; patients undergoing total knee arthroplasty (total knee replacement)
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Opioid; Narcotics; Anesthetics, Local; Morphine; Levobupivacaine
• Other Study ID Numbers: TKR-SMOH