QLB After Nephrectomy

Not Applicable

Completed

• Conditions: Chronic Postoperative Pain; Pain, Postoperative
• Interventions: Procedure: QLB; Device: PCA; Procedure: GA; Drug: Oxycodone; Drug: Sevoflurane; Drug: Fentanyl; Drug: Rocuronium

• Registration Number: NCT03529201
• Lead Sponsor: Medical University of Lublin

Brief Summary

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

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 Timeline

• Study First Submitted: 2018-05-01
• Study Start: 2018-05-07
• Study First Submitted QC: 2018-05-17
• Study First Posted: 2018-05-18
• Primary Completion: 2019-02-28
• Study Completion: 2019-08-25
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-22
• Last Update Posted: 2023-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
QLB	QLB	At the end of surgery, QLB with ropivacaine will be done on the side of the operation.
QLB	PCA	At the end of surgery, QLB with ropivacaine will be done on the side of the operation.
QLB	GA	At the end of surgery, QLB with ropivacaine will be done on the side of the operation.
QLB	Oxycodone	At the end of surgery, QLB with ropivacaine will be done on the side of the operation.
QLB	Sevoflurane	At the end of surgery, QLB with ropivacaine will be done on the side of the operation.
QLB	Fentanyl	At the end of surgery, QLB with ropivacaine will be done on the side of the operation.
Control	PCA	Standard care. No regional blocks.
Control	GA	Standard care. No regional blocks.
Control	Oxycodone	Standard care. No regional blocks.
Control	Sevoflurane	Standard care. No regional blocks.
QLB	Rocuronium	At the end of surgery, QLB with ropivacaine will be done on the side of the operation.
Control	Fentanyl	Standard care. No regional blocks.
Control	Rocuronium	Standard care. No regional blocks.

Primary Outcome Measures

Name	Time	Method
Total consumption of oxycodone	24 hours after the end of surgery.	Overall use of oxycodone administered by PCA pump will be assessed.

Secondary Outcome Measures

Name	Time	Method
Pain intensity	24 hours after the end of surgery	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.
Chronic pain	6 months after the surgery	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.

Trial Locations

Locations (2)

Department of Anesthesiology and Intensive Care, F. Chopin Hospital in Rzeszów; 🇵🇱 Rzeszów, Poland

Department of Anesthesiology and Intensive Care, J. Śniadecki Hospital in Białystok; 🇵🇱 Białystok, Poland