Lidocaine Irrigation in Shoulder Arthroscopy

October 18, 2023 updated by: Hassan Mokhtar Elshorbagy Hetta, Minia University

Efficacy of Lidocaine Saline Irrigation in Patients Undergoing Shoulder Arthroscopy: Randomized Controlled Study

Arthroscopic shoulder surgery is often associated with severe postoperative pain that is often significant enough to interfere with initial recovery and rehabilitation. The pain that can be difficult to manage without large dose of opioid.

The study aim to explore the effect of continuous irrigation of fluids mixed with lidocaine and epinephrine for analgesic consumption and postoperative pain after shoulder arthroscopy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Minya, Egypt, 61511
        • Minia university hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 56 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age 20-60
  • Both genders
  • Shoulder arthroscopy
  • ASA I-III

Exclusion Criteria:

  • Drug allergy
  • Psychiatric disorder
  • Opioid dependence
  • Liver disease
  • Patient refuse

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: lidocaine
The patients will undergo shoulder arthroscopy with lidocaine epinephrine fluids irrigation.
Drug: Lidocaine epinephrine
Under aseptic condition every one litre of fluid irrigation will be mixture with 10 ml of lidocaine 2% and 0.25mg epinephrine and the last one use before end of surgery dexamethasone 8 mg will be added.
Placebo Comparator: control group
The patients will undergo shoulder arthroscopy with epinephrine fluids irrigation only.
Drug: Epinephrin
0.25 mg epinephrine mixed with one litre of fluid irrigation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
total analgesic consumption
Time Frame: 24 hours
total nalbuphine consumed one day after surgery
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
first analgesic request
Time Frame: 24 hours
time of PCA request
24 hours
Visual analogue pain score
Time Frame: 24 hours
pain intensity at rest and movement from 0-10 which 0 no pain and 10 the worst pain
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minia University

Investigators

  • Principal Investigator: hassan m. hetta, lecturer, minia university/ faculty of medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 25, 2022

Primary Completion (Actual)

May 1, 2023

Study Completion (Actual)

August 1, 2023

Study Registration Dates

First Submitted

November 3, 2022

First Submitted That Met QC Criteria

November 21, 2022

First Posted (Actual)

November 22, 2022

Study Record Updates

Last Update Posted (Actual)

October 19, 2023

Last Update Submitted That Met QC Criteria

October 18, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 475:10/2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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