Clincosm LogoSign in Get a demo

Postoperative Analgesia in Patients Undergoing Percutaneous Nephrolithotomy

Sponsor
Ain Shams University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06078241
Collaborator
(none)
150
Enrollment
1
Location
3
Arms
5.9
Anticipated Duration (Months)
25.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Intravenous lidocaine infusion
  • Other: Erector spinae plane block (ESPB)
  • Other: Intravenous infusion of normal saline
  • Other: ESPB with normal saline
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Prevention
Official Title:
Intravenous Lidocaine Infusion Versus Ultrasound Guided Erector Spinae Plane Block for Postoperative Analgesia in Patients Undergoing Percutaneous Nephrolithotomy
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Apr 30, 2024
Anticipated Study Completion Date :
Apr 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Intravenous lidocaine infusion

Drug: Intravenous lidocaine infusion
Intravenous lidocaine infusion
Active Comparator: Erector spinae plane block (ESPB)

Other: Erector spinae plane block (ESPB)
Unilateral erector spinae plane block
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

Outcome Measures

Primary Outcome Measures

  1. Time to first rescue analgesia [24 hours postoperatively]

    Time to first rescue analgesia

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ain-Shams University Hospitals Cairo Egypt

Sponsors and Collaborators

  • Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ibrahim Mamdouh Esmat, Assistant Professor of Anesthesia and Intensive Care Department, Faculty of Medicine, Ain- shams University, Cairo, Egypt., Ain Shams University
ClinicalTrials.gov Identifier:
NCT06078241
Other Study ID Numbers:
  • FMASU MS 556/ 2023
First Posted:
Oct 11, 2023
Last Update Posted:
Oct 16, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Agnosia
Lidocaine

Study Results

No Results Posted as of Oct 16, 2023