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

March 9, 2011
March 9, 2011
August 2010
June 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
No Changes Posted
Opioid consumption in total in the first 48 hours postoperatively [ Time Frame: 48 hours postoperatively ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Total Knee Replacement
  • 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.
  • 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).
  • 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.
    Intervention: Drug: Levobupivacaine
  • 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).
    Intervention: Drug: Intrathecal morphine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
42
June 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
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
Ireland
 
NCT01312415
TKR-SMOH
No
Denise McCarthy, Anaesthesia Specialist Registrar, Cork University Hospital, Cork, Ireland
Cork University Hospital
Not Provided
Principal Investigator: Denise M McCarthy, MB FCARSCI Cork University Hospital
Cork University Hospital
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP