NCT06078241

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 11, 2023

Completed
21 days until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2024

Completed
Last Updated

November 26, 2024

Status Verified

November 1, 2024

Enrollment Period

1 year

First QC Date

October 5, 2023

Last Update Submit

November 23, 2024

Conditions

Postoperative Analgesia

Outcome Measures

Primary Outcomes (1)

  • Time to first rescue analgesia

    Time to first rescue analgesia

    24 hours postoperatively

Study Arms (3)

Intravenous lidocaine infusion

ACTIVE COMPARATOR
Drug: Intravenous lidocaine infusion

Erector spinae plane block (ESPB)

ACTIVE COMPARATOR
Other: Erector spinae plane block (ESPB)

Intravenous infusion of normal saline and ESPB with normal saline

PLACEBO COMPARATOR
Other: Intravenous infusion of normal salineOther: ESPB with normal saline

Interventions

Intravenous lidocaine infusionDRUG

Intravenous lidocaine infusion

Intravenous lidocaine infusion
Erector spinae plane block (ESPB)OTHER

Unilateral erector spinae plane block

Erector spinae plane block (ESPB)
Intravenous infusion of normal salineOTHER

Intravenous infusion of normal saline

Intravenous infusion of normal saline and ESPB with normal saline
ESPB with normal salineOTHER

Unilateral ESPB with normal saline

Intravenous infusion of normal saline and ESPB with normal saline

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Patient's refusal.
  • Known coagulopathy.
  • Known peripheral neuropathy or neurological deficits.
  • Chronic pain disorders.
  • Known allergy to study drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain-Shams University Hospitals

Cairo, Egypt

Location

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Anesthesia and Intensive Care Department, Faculty of Medicine, Ain- shams University, Cairo, Egypt.

Study Record Dates

First Submitted

October 5, 2023

First Posted

October 11, 2023

Study Start

November 1, 2023

Primary Completion

October 31, 2024

Study Completion

October 31, 2024

Last Updated

November 26, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)