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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2011 by Cork University Hospital.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Cork University Hospital

ClinicalTrials.gov Identifier:

NCT01312415

First received: March 9, 2011

Last updated: NA

Last verified: March 2011

History: No changes posted

Purpose

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.

Condition	Intervention	Phase
Total Knee Replacement	Drug: Levobupivacaine Drug: Intrathecal morphine	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	A Comparison of the Analgesic Efficacy of Local Anaesthetic Wound Infiltration Versus Intrathecal Morphine for Total Knee Replacement

Resource links provided by NLM:

MedlinePlus related topics: Knee Replacement

Drug Information available for: Morphine sulfate Bupivacaine hydrochloride Bupivacaine

U.S. FDA Resources

Further study details as provided by Cork University Hospital:

Primary Outcome Measures:

Quality of analgesia in the postoperative period as assessed by visual analogue score (VAS) for pain at rest and on movement [ Time Frame: 24 hours postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Opioid consumption in total in the first 48 hours postoperatively [ Time Frame: 48 hours postoperatively ] [ Designated as safety issue: No ]

Estimated Enrollment:	42
Study Start Date:	August 2010
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.
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).

Arms

Assigned Interventions

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.

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).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01312415

Contacts

Contact: Denise M McCarthy, MB FCARCSI	353-87-2341254	dmc_btown@yahoo.co.uk
Contact: Gabriella Iohom, MB PhD	353-21-4922135	iohom@hotmail.com

Locations

Ireland
St Mary Orthopedic Hospital	Recruiting
Cork, Ireland

Sponsors and Collaborators

Cork University Hospital

Investigators

Principal Investigator:

Denise M McCarthy, MB FCARSCI

Cork University Hospital

More Information

No publications provided

Responsible Party:	Denise McCarthy, Anaesthesia Specialist Registrar, Cork University Hospital, Cork, Ireland
ClinicalTrials.gov Identifier:	NCT01312415 History of Changes
Other Study ID Numbers:	TKR-SMOH
Study First Received:	March 9, 2011
Last Updated:	March 9, 2011
Health Authority:	Ireland: Research Ethics Committee

Keywords provided by Cork University Hospital:

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

Additional relevant MeSH terms:

Analgesics
Morphine
Anesthetics
Levobupivacaine
Bupivacaine
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents

Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Analgesics, Opioid
Narcotics

ClinicalTrials.gov processed this record on May 19, 2013

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