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Evaluation of the Transversus abdominis plane block (TAP-block) in preventing painful urine bladder spam in patients undergoing Robot Assisted Laparoscopic Radical Prostatectomy under general anesthesia, a prospective randomized controlled trial

Evaluation of the Transversus abdominis plane block (TAP-block) in preventing painful urine bladder spam in patients undergoing Robot Assisted Laparoscopic Radical Prostatectomy under general anesthesia, a prospective randomized controlled trial - TAP in RALP

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON31036
Enrollment
100
Registered
2007-10-15
Start date
2008-04-01
Completion date
Unknown
Last updated
2024-05-13

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

Conditions

bladder spasm

Interventions

A bilateral TAP-block is performed in patients undergoing a RALP for prostate cancer, randomized for TAP-block.

Sponsors

Antoni van Leeuwenhoek Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Men with prostate cancer scheduled for robot assisted laparoscopic radical prostatectomy (RALP)

Exclusion criteria

Exclusion criteria: Mental disorders. Inability to communicate in Dutch or English language Re-intervention procedures after (RALP) Conversion form RALP to an open procedure Allergy for amide type local anesthetic agents Allergy for oxybutinine, or butylscopolamine Allergy to acetaminophen Allergy to diclofenac.

Design outcomes

Primary

MeasureTime frame
The incidence rate of postoperative bladder spasm at 1 hour after arrival at the recovery room , 4 hours postoperatively and on the morning of the first postoperative day.

Secondary

MeasureTime frame
Pain by NRS (0 - 10) , done one hour after arrival at the recovery room , 4 hours postoperatively and on morning of the first postoperative day. Postoperative nausea and vomiting during the period end of the surgical procedure till 12:00 am of the first postoperative day. The cumulative dose of oxybutinine and butylscopolamine and morfine given between the arrival at the recovery room and 12 am on the morning of the first postoperative day.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)