Postoperative Analgesia in Patients Undergoing Percutaneous Nephrolithotomy

NCT ID: NCT06078241

Last Updated: 2024-11-26

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

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2024-10-31

Brief Summary

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Percutaneous nephrolithotomy (PCNL) is a minimally invasive procedure to remove stones from the kidney by a small puncture wound through the skin. Patients receiving lidocaine infusion had lower pain scores, reduced postoperative analgesic requirements and decreased intraoperative anesthetic requirements. Erector spinae plane block (ESPB) seems to be effective when compared with no block or a placebo block.

Detailed Description

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Conditions

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Postoperative Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Intravenous lidocaine infusion

Group Type ACTIVE_COMPARATOR

Intravenous lidocaine infusion

Intervention Type DRUG

Intravenous lidocaine infusion

Erector spinae plane block (ESPB)

Group Type ACTIVE_COMPARATOR

Erector spinae plane block (ESPB)

Intervention Type OTHER

Unilateral erector spinae plane block

Intravenous infusion of normal saline and ESPB with normal saline

Group Type PLACEBO_COMPARATOR

Intravenous infusion of normal saline

Intervention Type OTHER

Intravenous infusion of normal saline

ESPB with normal saline

Intervention Type OTHER

Unilateral ESPB with normal saline

Interventions

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Intravenous lidocaine infusion

Intravenous lidocaine infusion

Intervention Type DRUG

Erector spinae plane block (ESPB)

Unilateral erector spinae plane block

Intervention Type OTHER

Intravenous infusion of normal saline

Intravenous infusion of normal saline

Intervention Type OTHER

ESPB with normal saline

Unilateral ESPB with normal saline

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* American Society of Anesthesiologists (ASA) score I-II..
* Body mass index \< 35 kg/m2.

Exclusion Criteria

* Patient's refusal.
* Known coagulopathy.
* Known peripheral neuropathy or neurological deficits.
* Chronic pain disorders.
* Known allergy to study drugs
Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Ibrahim Mamdouh Esmat

Assistant Professor of Anesthesia and Intensive Care Department, Faculty of Medicine, Ain- shams University, Cairo, Egypt.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ain-Shams University Hospitals

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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FMASU MS 556/ 2023

Identifier Type: -

Identifier Source: org_study_id

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