Back to resultsPostoperative Analgesia in Patients Undergoing Percutaneous Nephrolithotomy
Primary Purpose
Postoperative Analgesia
Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Intravenous lidocaine infusion
Erector spinae plane block (ESPB)
Intravenous infusion of normal saline
ESPB with normal saline
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Analgesia
Eligibility Criteria
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
Sites / Locations
- Ain-Shams University Hospitals
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Intravenous lidocaine infusion
Erector spinae plane block (ESPB)
Intravenous infusion of normal saline and ESPB with normal saline
Arm Description
Outcomes
Primary Outcome Measures
Time to first rescue analgesia
Time to first rescue analgesia
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06078241
Brief Title
Postoperative Analgesia in Patients Undergoing Percutaneous Nephrolithotomy
Official Title
Intravenous Lidocaine Infusion Versus Ultrasound Guided Erector Spinae Plane Block for Postoperative Analgesia in Patients Undergoing Percutaneous Nephrolithotomy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Analgesia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intravenous lidocaine infusion
Arm Type
Active Comparator
Arm Title
Erector spinae plane block (ESPB)
Arm Type
Active Comparator
Arm Title
Intravenous infusion of normal saline and ESPB with normal saline
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Intravenous lidocaine infusion
Intervention Description
Intravenous lidocaine infusion
Intervention Type
Other
Intervention Name(s)
Erector spinae plane block (ESPB)
Intervention Description
Unilateral erector spinae plane block
Intervention Type
Other
Intervention Name(s)
Intravenous infusion of normal saline
Intervention Description
Intravenous infusion of normal saline
Intervention Type
Other
Intervention Name(s)
ESPB with normal saline
Intervention Description
Unilateral ESPB with normal saline
Primary Outcome Measure Information:
Title
Time to first rescue analgesia
Description
Time to first rescue analgesia
Time Frame
24 hours postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ibrahim Mamdouh Esmat
Phone
01001241928
Email
ibrahim_mamdouh@med.asu.edu.eg
Facility Information:
Facility Name
Ain-Shams University Hospitals
City
Cairo
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ibrahim Mamdouh Esmat
Email
ibrahim_mamdouh@med.asu.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Postoperative Analgesia in Patients Undergoing Percutaneous Nephrolithotomy
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