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Analgesic Efficacy of Ultrasound-guided Transverse-abdominal Plain Blockade in Urological Surgery

Ultrasound-guided Analgesic Transverse Abdominal Plain Blockade in the Multimodal Pain Management for Laparoscopic Urological Surgery. Analgesic Efficacy Assessment.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01501565
Enrollment
141
Registered
2011-12-29
Start date
2011-12-31
Completion date
2012-11-30
Last updated
2012-11-16

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

Conditions

Postoperative Pain

Keywords

Postoperative pain, Transverse abdominal blockade, Efficacy, Safety, Urology

Brief summary

The purpose of this study is to compare pain level (according to numerical score)at 4, 8, 12 and 24 postoperative hours between patients under transverse abdominal plain blockade (TAP) and patients under conventional analgesia. Also the opioid consumption is assessed.

Interventions

PROCEDUREPostoperative transverse abdominal plain (TAP) blockade

Bupivacaine 0.25%. Maximum 150 mg. A maximum of 75 mg bupivacaine is administered in each side (posterior and subcostal TAP) in a single puncture.

Sponsors

Fundacio Puigvert
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* \> 18 yrs. * Patients undergo laparoscopic urologic surgery * Physical status ASA \< 3 * Surgical procedure without complications * Signed informed consent

Exclusion criteria

* Allergy to bupivacaine chlorhydrate * Patients with chronic pain treatment * Alcoholism * Decompensated hepatic disease * Coagulation disorders * BMI \> 35 * Patient involved in another clinical trial

Design outcomes

Primary

MeasureTime frameDescription
Pain levelChange in pain from admittance to 24 hours postoperativelyPain is assessed by numerical scale (0 to 10) where 0 is no pain and 10 is the most intense pain possible. Pain will be assessed at 4, 6 , 8, 12 and 24 hours.

Secondary

MeasureTime frameDescription
Analgesic consumption as a rescue therapywithin 24 postoperative hoursAnalgesic consumption: morphine in miligrams.
Incidence of postoperative nausea and vomiting (PONV) related to therapywithin 24 postoperative hoursAssessment of PONV incidence and antiemetic drugs consumption.
Incidence of urethral/bladder spasmwithin 24 postoperative hoursPain due to bladder catheter.
Assessment of oral intake tolerancewithin 24 postoperative hoursAssessment at 6 postoperative hours for liquids, and solid food at 24 postoperative hours.
Patient satisfactionwithin 24 postoperative hoursAssessed by ordinal scale: Very pleased/Pleased/little pleased/little unpleased/unpleased/very unpleased

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026