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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03529201
Other study ID # KE-0254/328/2017
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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