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QLB After Nephrectomy

Primary Purpose

Pain, Postoperative, Chronic Postoperative Pain

Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
QLB
PCA
GA
Oxycodone
Sevoflurane
Fentanyl
Rocuronium
Sponsored by
Medical University of Lublin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Anesthesiology and Intensive Care, J. Śniadecki Hospital in BiałystokRecruiting
  • Department of Anesthesiology and Intensive Care, F. Chopin Hospital in RzeszówRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

QLB

Control

Arm Description

At the end of surgery, QLB with ropivacaine will be done on the side of the operation.

Standard care. No regional blocks.

Outcomes

Primary Outcome Measures

Total consumption of oxycodone
Overall use of oxycodone administered by PCA pump will be assessed.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
May 1, 2018
Last Updated
July 17, 2018
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
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1. Study Identification

Unique Protocol Identification Number
NCT03529201
Brief Title
QLB After Nephrectomy
Official Title
Effectiveness of Quadratus Lumborum Block After Nephrectomy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 7, 2018 (Actual)
Primary Completion Date
September 28, 2018 (Anticipated)
Study Completion Date
February 25, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the 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

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Chronic Postoperative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomly allocated to one of the study arms: QLB or control group.
Masking
Participant
Masking Description
A regional block will be performed under general anesthesia. Patients will not be aware of this procedure.
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
QLB
Arm Type
Experimental
Arm Description
At the end of surgery, QLB with ropivacaine will be done on the side of the operation.
Arm Title
Control
Arm Type
Experimental
Arm Description
Standard care. No regional blocks.
Intervention Type
Procedure
Intervention Name(s)
QLB
Intervention Description
On the side of the surgery, QLB with 0.375% ropivacaine (0.2 mL/kg)
Intervention Type
Device
Intervention Name(s)
PCA
Intervention Description
Patient-controlled analgesia
Intervention Type
Procedure
Intervention Name(s)
GA
Intervention Description
General anesthesia
Intervention Type
Drug
Intervention Name(s)
Oxycodone
Intervention Description
administered by PCA
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Intervention Description
Inhalational anesthetic during GA
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Intervention Description
painkiller during GA
Intervention Type
Drug
Intervention Name(s)
Rocuronium
Intervention Description
muscle relaxant during GA
Primary Outcome Measure Information:
Title
Total consumption of oxycodone
Description
Overall use of oxycodone administered by PCA pump will be assessed.
Time Frame
24 hours after the end of surgery.
Secondary Outcome Measure Information:
Title
Pain intensity
Description
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.
Time Frame
24 hours after the end of surgery
Title
Chronic pain
Description
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.
Time Frame
6 months after the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michał Borys, M.D., Ph.D.
Phone
+48506350569
Email
michalborys1@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mirosław Czuczwar, M.D., Ph.D.
Phone
+48509390985
Email
czuczwarm@gmail.com
Facility Information:
Facility Name
Department of Anesthesiology and Intensive Care, J. Śniadecki Hospital in Białystok
City
Białystok
ZIP/Postal Code
15-950
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Piotr Gałkin, M.D.
Phone
+48601397139
Email
piotr.galkin@anestezjolog.com.pl
Facility Name
Department of Anesthesiology and Intensive Care, F. Chopin Hospital in Rzeszów
City
Rzeszów
ZIP/Postal Code
35-055
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrycja Szajowska, M.D.
Phone
+48504068425
Email
patrycjaguzek@poczta.onet.pl

12. IPD Sharing Statement

Plan to Share IPD
No

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QLB After Nephrectomy

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