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Ultrasound Guided Thoracic ESPB for Post Mastectomy Pain Control, Comparing 2 Dosing Regimens of Lidocaine With Different Drug Volumes

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05514977
Collaborator
(none)
82
Enrollment
1
Location
2
Arms
3.9
Anticipated Duration (Months)
20.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The investigators compare 2 different drug regimens using 2 different volumes of lidocaine with the same drug content (i.e. different concentrations) as regards efficacy of post operative analgesia following mastectomy surgery

Condition or Disease Intervention/Treatment Phase
  • Procedure: Erector spine plane block
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
82 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Supportive Care
Official Title:
Ultrasound Guided Thoracic Erector Spine Plane Block for Post Mastectomy Pain Control, Effect of Volume With Constant Drug Mass, a Randomized Controlled Trial
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Nov 15, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: L group

Patients are given 20 ml of 2 % lidocaine for ESPB

Procedure: Erector spine plane block
Thoracic ESPB
Active Comparator: H group

Patients are given 40 ml of 1 % lidocaine for ESPB

Procedure: Erector spine plane block
Thoracic ESPB

Outcome Measures

Primary Outcome Measures

  1. Effective analgesia [First 24 hours]

    Morphine supplements needed

Secondary Outcome Measures

  1. Analgesic efficiency [Every 2 hours in the first 24 hours]

    Visual analog scale; ranging from 0 to 10 where 0 is no pain and 10 is pain in its worst form

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • ASA 2 & 3 for elective breast cancer surgery
Exclusion Criteria:

  • ASA > 3

  • BMI > 35 kg/m2

  • Contraindications to LA (coagulopathy and local infection)

  • Allergy to the drug

  • Cardiac, hepatic and renal patients

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cairo university Cairo Egypt

Sponsors and Collaborators

  • Cairo University

Investigators

  • Study Director: Ahmed Kareem, Kasr alainy hospital, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ahmed Kareem, Assistant professor, Cairo University
ClinicalTrials.gov Identifier:
NCT05514977
Other Study ID Numbers:
  • LOW VS HIGH VOLUME LIDOCAINE
First Posted:
Aug 25, 2022
Last Update Posted:
Aug 25, 2022
Last Verified:
Aug 1, 2022
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
Product Manufactured in and Exported from the U.S.:
No

Study Results

No Results Posted as of Aug 25, 2022