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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01501565
• Other study ID #: FP2011/01
• Secondary ID: 2011-003219-53
• Status: Completed
• Phase: Phase 4
• First received: December 22, 2011
• Last updated: November 15, 2012
• Start date: December 2011
• Est. completion date: November 2012

Study information

• Verified date: November 2012
• Source: Fundacio Puigvert
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• Postoperative 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.

Locations

Country	Name	City	State
Spain	Fundació Puigvert	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundacio Puigvert

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain level	Pain 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.	Change in pain from admittance to 24 hours postoperatively	No
Secondary	Analgesic consumption as a rescue therapy	Analgesic consumption: morphine in miligrams.	within 24 postoperative hours	Yes
Secondary	Incidence of postoperative nausea and vomiting (PONV) related to therapy	Assessment of PONV incidence and antiemetic drugs consumption.	within 24 postoperative hours	Yes
Secondary	Incidence of urethral/bladder spasm	Pain due to bladder catheter.	within 24 postoperative hours	Yes
Secondary	Assessment of oral intake tolerance	Assessment at 6 postoperative hours for liquids, and solid food at 24 postoperative hours.	within 24 postoperative hours	Yes
Secondary	Patient satisfaction	Assessed by ordinal scale: Very pleased/Pleased/little pleased/little unpleased/unpleased/very unpleased	within 24 postoperative hours	No