QLB After Nephrectomy

Pain, Postoperative Clinical Trial

Official title:

Effectiveness of Quadratus Lumborum Block After Nephrectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03529201
• Other study ID #: KE-0254/328/2017
• Status: Completed
• Phase: N/A
• Start date: May 7, 2018
• Est. completion date: August 25, 2019

Study information

• Verified date: November 2023
• Source: Medical University of Lublin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: August 25, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Postoperative Pain
• Pain, Postoperative

Intervention

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
• Sevoflurane
Inhalational anesthetic during GA
• Fentanyl
painkiller during GA
• Rocuronium
muscle relaxant during GA

Locations

Country	Name	City	State
Poland	Department of Anesthesiology and Intensive Care, J. Sniadecki Hospital in Bialystok	Bialystok
Poland	Department of Anesthesiology and Intensive Care, F. Chopin Hospital in Rzeszów	Rzeszów

Sponsors (3)

Lead Sponsor	Collaborator
Medical University of Lublin	Department of Anesthesiology and Intensive Care, F. Chopin Hospital in Rzeszów, Department of Anesthesiology and Intensive Care, J. Sniadecki Hospital in Bialystok

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total consumption of oxycodone	Overall use of oxycodone administered by PCA pump will be assessed.	24 hours after the end of surgery.
Secondary	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
Secondary	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