Subcostal TAP Block For Percutaneous Nephrolithotomy

NCT03454139 | Completed

• 1 other identifier: 186
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Nephrolithiasis

Keywords

percutaneous nephrolithotomy; subcostal transversus abdominis plane block; pain; paracetamol; tramadol; morphine; nephrolithiasis; lidocaine; bupivacaine

Outcome Measures

Primary Outcomes (1)

• Total morphine used (milligram)

  Morphine patient controlled analgesia (PCA) is applied for both patient groups. PCA settings are bolus: 1 mg Morphine and lock time:10 minutes.

  48 hours after the end of the surgery

Secondary Outcomes (4)

• Morphine consumption (milligram)

  1- 0 minutes; 2- 30 minutes; 3- 1 hour; 4- 2 hours; 5- 3 hours; 6- 12 hours; 7- 24 hours; 8- 48 hours after the end of the surgery

• Additional analgesic requirement

  1- 0 minutes; 2- 30 minutes; 3- 1 hour; 4- 2 hours; 5- 3 hours; 6- 12 hours; 7- 24 hours; 8- 48 hours after the end of the surgery

• Visual Analog Scale (VAS)

  1- 0 minutes; 2- 30 minutes; 3- 1 hour; 4- 2 hours; 5- 3 hours; 6- 12 hours; 7- 24 hours; 8- 48 hours after the end of the surgery

• Fentanyl consumption (microgram/kg)

  0 minute after the end of the surgery

Study Arms (2)

Subcostal TAP group

ACTIVE COMPARATOR

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.

Procedure: Subcostal transversus abdominis plane block

Non- TAP group

NO INTERVENTION

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.

Interventions

Subcostal transversus abdominis plane block 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.

Subcostal TAP group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead

MeSH Terms

Conditions

Nephrolithiasis; Pain

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: February 12, 2018
• First Posted: March 5, 2018
• Study Start: October 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: September 1, 2017
• Last Updated: March 13, 2018

Record last verified: 2018-03