A comparison of the efficacy of levobupivacaine 0,125%, ropivacaine 0,125% and ropivacaine 0,2%, all combined with sufentanil 0.5 micrograms/mL, in patient-controlled epidural analgesia after hysterectomy under combined epidural and general anesthesia

Phase 4

Completed

Conditions: hysterectomy
removal of uterus
10029903

Registration Number: NL-OMON30436

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 63

Inclusion Criteria

*Female patient >18 years
*ASA class I-III
*Patients undergoing abdominal hysterectomy under combined epidural and general anesthesia
*Written informed consent

Exclusion Criteria

*Participation in a trial on investigational drugs within 3 months prior to the study
*Known hypersensitivity to amide-type local anesthetics
*Known hypersensitivity to opioids
*Known history of severe cardiovascular, hepatic, renal, respiratory, endocrinological, haematological, neurological or psychiatric disease as judged by the investigator
*Known history of peripheral neuropathies
*Those receiving chronic analgesic therapy
*Any contraindication for epidural analgesia (e.g. clotting disorders, history of lumbar surgery)
*Inability to perform VAS score
*Pregnancy or lactation
*Any other reason which in the opinion of the investigator makes the patient unsuitable for participation in the study

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Number of requests of patient-controlled 2 mL boluses (granted and refused)<br /><br>Visual analogue scale (100 mm) scores for resting pain at T = 6, 12, 24 and 48<br /><br>hours<br /><br>Motor block (0-12) scores for the lower extremities motor blockade at T = 6,<br /><br>12, 24 and 48 hours<br /><br>Level of sensory blockade (number of dermatomes) at T = 6, 12, 24, and 48<br /><br>hours (thermal sensation)<br /><br>Systolic and diastolic blood pressure, heart rate, mixed venous oxygen<br /><br>saturation by pulse-oximetry and respiratory rate at T = 6, 12, 24,and 48 hours<br /><br>Time of removal of the epidural catheter<br /><br>Incidence of nausea, pruritus, hypotension or sedation<br /><br>Overall patient satisfaction with pain treatment (scale 1-10)</p><br>

Secondary Outcome Measures