QLB After Nephrectomy

NCT ID: NCT03529201

Last Updated: 2023-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-07

Study Completion Date

2019-08-25

Brief Summary

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

Detailed Description

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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.

Conditions

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Pain, Postoperative Chronic Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients will be randomly allocated to one of the study arms: QLB or control group.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
A regional block will be performed under general anesthesia. Patients will not be aware of this procedure.

Study Groups

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QLB

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

Group Type EXPERIMENTAL

QLB

Intervention Type PROCEDURE

On the side of the surgery, QLB with 0.375% ropivacaine (0.2 mL/kg)

PCA

Intervention Type DEVICE

Patient-controlled analgesia

GA

Intervention Type PROCEDURE

General anesthesia

Oxycodone

Intervention Type DRUG

administered by PCA

Sevoflurane

Intervention Type DRUG

Inhalational anesthetic during GA

Fentanyl

Intervention Type DRUG

painkiller during GA

Rocuronium

Intervention Type DRUG

muscle relaxant during GA

Control

Standard care. No regional blocks.

Group Type EXPERIMENTAL

PCA

Intervention Type DEVICE

Patient-controlled analgesia

GA

Intervention Type PROCEDURE

General anesthesia

Oxycodone

Intervention Type DRUG

administered by PCA

Sevoflurane

Intervention Type DRUG

Inhalational anesthetic during GA

Fentanyl

Intervention Type DRUG

painkiller during GA

Rocuronium

Intervention Type DRUG

muscle relaxant during GA

Interventions

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QLB

On the side of the surgery, QLB with 0.375% ropivacaine (0.2 mL/kg)

Intervention Type PROCEDURE

PCA

Patient-controlled analgesia

Intervention Type DEVICE

GA

General anesthesia

Intervention Type PROCEDURE

Oxycodone

administered by PCA

Intervention Type DRUG

Sevoflurane

Inhalational anesthetic during GA

Intervention Type DRUG

Fentanyl

painkiller during GA

Intervention Type DRUG

Rocuronium

muscle relaxant during GA

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Department of Anesthesiology and Intensive Care, F. Chopin Hospital in Rzeszów

UNKNOWN

Sponsor Role collaborator

Department of Anesthesiology and Intensive Care, J. Śniadecki Hospital in Białystok

UNKNOWN

Sponsor Role collaborator

Medical University of Lublin

OTHER

Sponsor Role lead

Responsible Party

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Michał Borys

M.D., Ph.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Anesthesiology and Intensive Care, J. Śniadecki Hospital in Białystok

Bialystok, , Poland

Site Status

Department of Anesthesiology and Intensive Care, F. Chopin Hospital in Rzeszów

Rzeszów, , Poland

Site Status

Countries

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Poland

Other Identifiers

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KE-0254/328/2017

Identifier Type: -

Identifier Source: org_study_id