NCT01501565CompletedPhase 4
Ultrasound-guided Analgesic Transverse Abdominal Plain Blockade in the Multimodal Pain Management for Laparoscopic Urological Surgery. Analgesic Efficacy Assessment.
Fundacio Puigvert2 sites in 1 country141 target enrollmentStarted: December 1, 2011Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 141
- Locations
- 2
- Primary Endpoint
- Pain level
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Pain level
Time Frame: Change in pain from admittance to 24 hours postoperatively
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.
Secondary Outcomes
- Analgesic consumption as a rescue therapy(within 24 postoperative hours)
- Incidence of postoperative nausea and vomiting (PONV) related to therapy(within 24 postoperative hours)
- Incidence of urethral/bladder spasm(within 24 postoperative hours)
- Assessment of oral intake tolerance(within 24 postoperative hours)
- Patient satisfaction(within 24 postoperative hours)
Investigators
Juan Francisco Mayoral Farre
Principal Investigator
Fundacio Puigvert
Study Sites (2)
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