Subcostal TAP Block For Percutaneous Nephrolithotomy

NCT ID: NCT03454139

Last Updated: 2018-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2017-09-30

Brief Summary

Percutaneous nephrolithotomy (PCNL) is a minimally- invasive procedure for removing kidney stones. The small incision of PCNL is performed medially from the posterior axillary line according to stones location. Despite the small skin incision patients suffer from postoperative pain due to visceral pain and intercostal nerve injury. The aim of this study is to evaluate the perioperative analgesic effect of subcostal transversus abdominis plane (TAP) block performed prior to PCNL procedure.

Primary outcome of our study was Morphine consumption at 48th hour after the surgery. Secondary outcomes were perioperative fentanyl consumption; postoperative Verbal Analog Scale and additional analgesic drug requirement.

Detailed Description

Patients who were scheduled for elective percutaneous nephrolithotomy were randomized into two groups: Group TAP and Group IV. General anesthesia was induced with propofol 2 mg/kg, fentanyl 1 mcgr/kg and rocuronium 0,6 mg/kg and maintained with sevoflurane 2% in 40%:60% oxygen/air mixture and fentanyl 0,5 mcgr/kg and rocuronium 10 mg, if necessary. Unilateral Transversus abdominis plane block was performed with total of 30 ml volume of local anesthetic solution (20ml Bupivacaine 0,125% and 10ml Lidocaine 1%) after intubation but before surgery to the Group TAP patients. Paracetamol 1 gr, iv was given to the Group IV 20 minutes before the end of the surgery. Also 100mg Tramadol,iv was administered 20 minutes before the end of the surgery to the both groups. Morphine iv patient controlled analgesia was applied to both groups. Perioperative fentanyl consumption; postoperative Verbal Analog Scale, morphine consumption and additional analgesic drug requirement were determined. Data of perioperative complications and adverse effects were also collected. Chi square with Yates correction and Mann Whitney U tests were used for statistical analysis.

Conditions

Nephrolithiasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Subcostal TAP group

Ultrasound guided Subcostal transversus abdominis plane block is performed after anesthesia induction and endotracheal intubation , to the side where kidney stone is. A composition of 10 ml Lidocaine %1 plus 10 ml physiologic saline solution plus 10 ml Bupivacaine %0,25 , total of 30 ml of local anesthetic mixture is administered into the area between internal oblique muscle fascia and transversus abdominis muscle fascia. After that, the patient is positioned to lithotomy position and the open-end catheter is inserted. After that the patient is turned to prone position and the percutaneous nephrolithotomy is performed. Tramadol 100 mg iv is administrated 20 minutes before the end of the surgery. Morphine patient controlled analgesia is planned for postoperative pain management.

Group Type: ACTIVE_COMPARATOR

Subcostal transversus abdominis plane block

Intervention Type: PROCEDURE

Ultrasound guided Subcostal transversus abdominis plane block is performed after anesthesia induction and endotracheal intubation , to the side where kidney stone is. A composition of 10 ml Lidocaine %1 plus 10 ml physiologic saline solution plus 10 ml Bupivacaine %0,5 , total of 30 ml of local anesthetic mixture is administered into the area between internal oblique muscle fascia and transversus abdominis muscle fascia.

Non- TAP group

Percutaneous nephrolithotomy is performed under general anesthesia. No regional analgesia is administered to this patients. Paracetamol 1000 mg/100ml; iv and Tramadol 100mg iv is administered 20 minutes before the end of the surgery for postoperative analgesia. Morphine patient controlled analgesia is planned for postoperative pain management.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Subcostal transversus abdominis plane block

Ultrasound guided Subcostal transversus abdominis plane block is performed after anesthesia induction and endotracheal intubation , to the side where kidney stone is. A composition of 10 ml Lidocaine %1 plus 10 ml physiologic saline solution plus 10 ml Bupivacaine %0,5 , total of 30 ml of local anesthetic mixture is administered into the area between internal oblique muscle fascia and transversus abdominis muscle fascia.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• patients enrolled for percutaneous nephrolithotomy (PCNL) surgery
• ASA (American Society of Anesthesiologists) score I-III

Exclusion Criteria

• patients with chronic pain
• patients on opioid or other analgesic drugs
• BMI (body mass index) higher than 40
• allergies for drugs used in the study
• chronic renal failure receiving dialysis

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul University

OTHER

Sponsor Role: lead

Responsible Party

Guniz M.Koksal

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

186

Identifier Type: -

Identifier Source: org_study_id