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

Study Overview
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Brief Summary
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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.

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

Conditions
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Postoperative Pain

Intervention / Treatment
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* Procedure: Postoperative transverse abdominal plain (TAP) blockade


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Standard analgesic therapy: iv Metamizol 2 g q8h | |
| Experimental: TAP<br>Transverse abdominal plain (TAP) blockade with local anesthetic: Bupivacaine chlorhydrate 0.25% adjusted by weight and type of surgery. Maximum dose: 150 mg of bupivacaine. Two approaches are done: 1)Posterior TAP: the needle insertion point is cephalad to the iliac crest, behind the midaxillary line. The needle is inserted under ultrasound guidance in plane. Local anesthetics is deposited between the internal oblique and transversus abdominis muscles, 2)Subcostal TAP: the needle is inserted ultrasound guided perpendicularly to abdominal wall, directed parallel to the costal margin but oblique to the sagittal plane. Local anesthestic is deposited between transversus abdominis and the rectus abdominis muscles. | Procedure: Postoperative transverse abdominal plain (TAP) blockade<br>* 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.<br>* Other names: Buivacaine: Inibsicain (R) 0.25% (INIBSA, S.A.);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesic consumption as a rescue therapy | Analgesic consumption: morphine in miligrams. | within 24 postoperative hours | 
| Incidence of postoperative nausea and vomiting (PONV) related to therapy | Assessment of PONV incidence and antiemetic drugs consumption. | within 24 postoperative hours | 
| Incidence of urethral/bladder spasm | Pain due to bladder catheter. | within 24 postoperative hours | 
| Assessment of oral intake tolerance | Assessment at 6 postoperative hours for liquids, and solid food at 24 postoperative hours. | within 24 postoperative hours | 
| Patient satisfaction | Assessed by ordinal scale: Very pleased/Pleased/little pleased/little unpleased/unpleased/very unpleased | within 24 postoperative hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative pain, Transverse abdominal blockade, Efficacy, Safety, Urology