Epidural analgesia or opatient controlled regional analgesia for radical Retropubic Prostatectomy. A randomized, double-blind study.
- Conditions
- Postoperative pain after radical retropubic prostatectomy
- Registration Number
- EUCTR2006-005518-11-SE
- Lead Sponsor
- Örebro University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Male
- Target Recruitment
- 58
1 < 75 year old patients undergoing radical retropubic prostatectomy for prostate cancer.
2. ASA I – II.
3. Have signed and dated Informed Consent.
4. Willing and able to comply with the protocol for the duration of the trial.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Patients with chronic pain who are taking analgesics regularly.
2. Known contraindications for epidural analgesia
3. Allergy/intolerance to morphine, adrenaline, fentanyl or ropivacaine
4. Patients on anticoagulants or with impaired coagulation status.
5. Participation in another clinical trial.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Is the pain relief achieved using patient controlled regional analgesia technique (PCRA) equally good as that achieved pain relief using the epidural technique (CEA) on postoperative pain during the first 48 h after radical retropubic prostatectomy?;Secondary Objective: Can efficient post-operative pain improved patient outcome following radical retropubic prostatectomy hysterectomy?;Primary end point(s): Post-operative pain (coughing at 4 h after the surgery) assessed on the basis of NRS (Numeric Rating Score). <br>.<br>
- Secondary Outcome Measures
Name Time Method