Postoperative Analgesia in Patients Undergoing Percutaneo... | NCT06078241

Studies
Postoperative Analgesia in Patients Undergoing Percutaneous Nephrolithotomy

NCT06078241

Sponsor

Ain Shams University

Status

Completed

Last Update Posted

Nov 26, 2024Actual

Enrollment

150Actual

Phase

Not Applicable

Conditions

Postoperative Analgesia

Interventions

Intravenous lidocaine infusion
Erector spinae plane block (ESPB)
Intravenous infusion of normal saline
ESPB with normal saline

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2023Actual

Primary Completion Date

Oct 31, 2024Actual

Completion Date

Oct 31, 2024Actual

First Submitted Date

Oct 5, 2023

First Submission Date that Met QC Criteria

Oct 5, 2023

First Posted Date

Oct 11, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 23, 2024

Last Update Posted Date

Nov 26, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ibrahim Mamdouh Esmat, Assistant Professor of Anesthesia and Intensive Care Department, Faculty of Medicine, Ain- shams University, Cairo, Egypt., Ain Shams UniversityPrincipal Investigator

Lead Sponsor

Ain Shams UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
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 saline Other: ESPB with normal saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intravenous lidocaine infusion	Drug	Intravenous lidocaine infusion	Intravenous lidocaine infusion

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ain-Shams University Hospitals		Cairo			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077330	Saline Solution

Ancestor Terms

ID	Term
D000077324	Crystalloid Solutions
D007552	Isotonic Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations

Browse Leaves

Not provided

Browse Branches

Not provided