Epidural analgesia or opatient controlled regional analgesia for radical Retropubic Prostatectomy. A randomized, double-blind study.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-005518-11-SE

Enrollment

Registered

2006-11-10

Start date

2007-01-24

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative pain after radical retropubic prostatectomy

Interventions

Trade Name: Leptanal Pharmaceutical Form: Solution for injection INN or Proposed INN: Fentanyl Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal Concentration number: 50- Pha

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1 =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
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). .	—

Measure

Time frame

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). .

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Countries

Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026