Postoperative Analgesia in Patients Undergoing Percutaneous Nephrolithotomy

November 16, 2023 updated by: Ibrahim Mamdouh Esmat, Ain Shams University

Intravenous Lidocaine Infusion Versus Ultrasound Guided Erector Spinae Plane Block for Postoperative Analgesia in Patients Undergoing Percutaneous Nephrolithotomy

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Erector spinae plane block (ESPB)
Other: Erector spinae plane block (ESPB)
Unilateral erector spinae plane block
Active Comparator: Intravenous lidocaine infusion
Drug: Intravenous lidocaine infusion
Intravenous lidocaine infusion
Placebo Comparator: Intravenous infusion of normal saline and ESPB with normal saline
Other: Intravenous infusion of normal saline
Intravenous infusion of normal saline
Other: ESPB with normal saline
Unilateral ESPB with normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first rescue analgesia
Time Frame: 24 hours postoperatively
Time to first rescue analgesia
24 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

April 30, 2024

Study Registration Dates

First Submitted

October 5, 2023

First Submitted That Met QC Criteria

October 5, 2023

First Posted (Actual)

October 11, 2023

Study Record Updates

Last Update Posted (Estimated)

November 17, 2023

Last Update Submitted That Met QC Criteria

November 16, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU MS 556/ 2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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