Postoperative Patient Controlled Epidural Analgesia After Total Knee Arthroplasty With 2ug/ml Fentanyl Combine With 0.2% Ropivacaine or 0.2% Levobupivcaine

NCT ID: NCT01158586

Last Updated: 2010-07-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2010-12-31

Brief Summary

Postoperative epidural analgesia (EA) is an effective and well-accepted modality of pain relief technique after having total knee replacement operation(1,4). Patient controlled epidural analgesia (PCEA) has been shown to be safe and effective in standard ward setting(2) and results in reduced epidural analgesic requirements(3). Besides, it also bear the advantage of avoidance of overdose, reduction of waiting times and involvement of patients in their analgesic regimen(3). Both ropivacaine and levobupivacaine are the local anaesthetic using in epidural analgesia which has been proven to be safe and effective(4). 0.2% Ropivacaine with 2ug/ml fentanyl has been used in our locality for more than 8 years. Another local anaesthetics, levobupivacaine, a S-enantiomer of bupivacaine has come up in Hong Kong, which has been proved to be safe, effective and may be better value for money. These two drugs has been proven to have similar analgesic potency in using as EA for postoperative pain relief for other operation(5,6,7) and for orthropaedics operation but in different concentration(4). Concerns have been raised about the introduction of the levobupivacaine in the departmental protocol. Objectives of this study are A)to determine the equivalence of two local anaesthetics regimen ; 0.2% ropivacaine with 2ug/ml fentanyl and 0.2% levobupivacaine with 2ug/ml fentanyl and B) to assess the cost-effectiveness of using these two regimens.

The null hypothesis is that the difference of analgesic effect, presented with visual analogue score, of two patient controlled epidural analgesia regimen, the 0.2% ropivacaine with 2 ug/ml fentanyl and 0.2% levobupivacaine with 2ug/ml fentanyl is higher than the threshold of 9 mm VAS. (8,9,10)

Conditions

Arthroplasty, Replacement, Knee; Patient-controlled Analgesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Levobupivacaine

patient control epidural analgeisa using 0.2% levobupivacaine with 2ug/ml fentanyl

Group Type: EXPERIMENTAL

Levobupivacaine

Intervention Type: DRUG

patient control epidural analgesia using 0.2% levobupivacaine with 2ug/ml fentanyl

Ropivacaine

patient controlled epidural analgesia using 0.2% ropivacaine with 2ug/ml fentanyl

Group Type: ACTIVE_COMPARATOR

Levobupivacaine

Intervention Type: DRUG

patient control epidural analgesia using 0.2% levobupivacaine with 2ug/ml fentanyl

Interventions

Levobupivacaine

patient control epidural analgesia using 0.2% levobupivacaine with 2ug/ml fentanyl

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• > 18 years old, ASA I -III and
• Undergoing total knee arthroplasty
• Combine spinal-epidural anaesthesia

Exclusion Criteria

• Known hypersensitivity to amide-type local anaesthetics
• Known hypersensitivity to opioids
• Known history of severe cardiovascular, renal, hepatic, neurological or psychiatric disease as judged by the investigator
• Known history of peripheral neuropathies
• Those receiving chronic analgesic therapy, or any contraindication for epidural analgesia (e.g. clotting disorders, or history of lumbar surgery)
• Inability to perform a pain score, or pregnancy or lactation

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United Christian Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hospital Authority

Locations

United Christian Hospital

Hong Kong, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Anthony Njo, MBBS; FHKCA; FANZCA

Role: CONTACT

njokhnjo@yahoo.com.hk

852-35136175

Timothy Brake

Role: CONTACT

References

Reference 1. Block et al. Efficiancy of postoperative epidural analgesia: A meta-analysis. JAMA 290: 2455-63 2. Werawatganon T. Patient controlled intravenous opioid analgesia versus continuous epidural analgesia for pain after intra-abdominal surgery. The Cochrane Databas of systemic reviews. Issue 3 Art. No.: No.: CD 004044. DOI: 10.1002/14651858. CD004088.pub2. 3. Liu SS et al. Patient-controlled epidural analgesia with bupivacaine and fentanyl on hospital wards: propective experience with 1,030 surgical patients Anesthesiology 88: 388-95 4. Silvasti M et al. Patient-controlled analgesia versus continuous epidural analgesia after total knee arthroplasty Acta Anaesthesiol Scand 42: 576 - 80 5. Stand T et al. Patient-controlled epidural analgesia reduces analgesic requirements compared to continuous epidural infusion after major abdominal surgery. Can J Anaesth 50:258-64 6. Linda S. et al. Relative Analgesic Potencies of Levobupivacaine and Ropivacaine for Epidural Analgesia in Labor. Anesthesiology 2003; 99:1354-8 7. Marc Senard et al. Epidural Levobupivacaine 0.1% or Ropivacaine 0.1% Combined with Morphine Provides Comparable Analgesia After Abdominal Surgery Anesth Analg 2004;98:389-94 8. Kelly AM The minimum clinically significant difference in visual analogue scale pain score does not differ with severity of pain.Emerg Med J 2001; 18:205-07 9. Mark MSM et al. The minimum clinically significant difference in visual analogue scale pain score in a local emergency setting. Hong Kong Journal of Emergency Medicine 2009; 16(4): 234-6 10. Kelly AM. Does the clinically significant difference in visual analog scale pain scores vary with gender, age, or cause of pain? Acad Emerg Med. 1998 Nov; 5(11): 1086-90.

Reference Type: BACKGROUND

Other Identifiers

PCEA-LEVO-ROPI

Identifier Type: -

Identifier Source: org_study_id