QLB After Nephrectomy

Effectiveness of Quadratus Lumborum Block After Nephrectomy

Oxycodone consumption and postoperative pain intensity in patients undergoing nephrectomy procedures. Of all study participants, 50% will obtain quadratus lumborum block (QLB).

Study Overview

• Status: Unknown
• Conditions: Pain, Postoperative; Chronic Postoperative Pain
• Intervention / Treatment: Procedure: QLB; Device: PCA; Procedure: GA; Drug: Oxycodone; Drug: Sevoflurane; Drug: Fentanyl; Drug: Rocuronium

Detailed Description

Patients undergoing nephrectomy procedures will be allocated to one of the study arms. At the end of an operation, still under general anesthesia, 50% patients will obtain QLB with ropivacaine.

Ultrasound-guided QLB will be performed on the side of surgery with 0.375% ropivacaine solution (0.2 mL per kg).

Every patient will get patient-controlled analgesia pump with oxycodone in the postoperative period.

Postoperative pain will be measured with VAS (visual-analogue scale) 2, 4, 8, 12 and 24 hours after the end of the operation. 24 -hours period.

At the 1, 3, 6 months patients will be interviewed by phone to assess neuropathic pain. Neuropathic Pain Symptom Inventory (NPSI) will be used.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michał Borys, M.D., Ph.D.; Phone Number: +48506350569; Email: michalborys1@gmail.com
• Study Contact Backup: Name: Mirosław Czuczwar, M.D., Ph.D.; Phone Number: +48509390985; Email: czuczwarm@gmail.com

Study Locations

• Poland
  • Białystok, Poland, 15-950
    • Recruiting
    • Department of Anesthesiology and Intensive Care, J. Śniadecki Hospital in Białystok
    • Contact: Piotr Gałkin, M.D.; Phone Number: +48601397139; Email: piotr.galkin@anestezjolog.com.pl
  • Rzeszów, Poland, 35-055
    • Recruiting
    • Department of Anesthesiology and Intensive Care, F. Chopin Hospital in Rzeszów
    • Contact: Patrycja Szajowska, M.D.; Phone Number: +48504068425; Email: patrycjaguzek@poczta.onet.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• obtained consent
• nephrectomy procedure

Exclusion Criteria:

• coagulopathy allergy to local anesthetics depression, antidepressant drugs treatment epilepsy usage of painkiller before surgery addiction to alcohol or recreational drugs

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: QLB; At the end of surgery, QLB with ropivacaine will be done on the side of the operation.	Procedure: QLB; On the side of the surgery, QLB with 0.375% ropivacaine (0.2 mL/kg); Device: PCA; Patient-controlled analgesia; Procedure: GA; General anesthesia; Drug: Oxycodone; administered by PCA; Drug: Sevoflurane; Inhalational anesthetic during GA; Drug: Fentanyl; painkiller during GA; Drug: Rocuronium; muscle relaxant during GA
EXPERIMENTAL: Control; Standard care. No regional blocks.	Device: PCA; Patient-controlled analgesia; Procedure: GA; General anesthesia; Drug: Oxycodone; administered by PCA; Drug: Sevoflurane; Inhalational anesthetic during GA; Drug: Fentanyl; painkiller during GA; Drug: Rocuronium; muscle relaxant during GA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total consumption of oxycodone	Overall use of oxycodone administered by PCA pump will be assessed.	24 hours after the end of surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	Pain intensity measured on VAS scale at the 2, 4, 8, 12, 24 hours. VAS in milimmeters. Minimum value 0, maximum 100. Less better - less severe pain. 0 no pain at all.	24 hours after the end of surgery
Chronic pain	Chronic pain occurrence assessed with Neuropathic Pain Symptom Inventory (NPSI) 10 descriptive variables, each one from 0 to 10. 0 means no pain. 10 very high chance of occurrence of neuropathic pain.	6 months after the surgery

Collaborators and Investigators

• Sponsor: Medical University of Lublin
• Collaborators: Department of Anesthesiology and Intensive Care, F. Chopin Hospital in Rzeszów; Department of Anesthesiology and Intensive Care, J. Śniadecki Hospital in Białystok

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 7, 2018
• Primary Completion (ANTICIPATED): September 28, 2018
• Study Completion (ANTICIPATED): February 25, 2019

Study Registration Dates

• First Submitted: May 1, 2018
• First Submitted That Met QC Criteria: May 17, 2018
• First Posted (ACTUAL): May 18, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 18, 2018
• Last Update Submitted That Met QC Criteria: July 17, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Platelet Aggregation Inhibitors; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Inhalation; Neuromuscular Agents; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Fentanyl; Sevoflurane; Oxycodone; Rocuronium
• Other Study ID Numbers: KE-0254/328/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No