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Lidocaine Irrigation in Shoulder Arthroscopy

Primary Purpose

Postoperative Pain, Analgesia

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Lidocaine epinephrine

Epinephrin

About this trial

This is an interventional prevention trial for Postoperative Pain focused on measuring Postoperative pain, Lidocaine, Shoulder arthroscopy

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Age 20-60 Both genders Shoulder arthroscopy ASA I-III Exclusion Criteria: Drug allergy Psychiatric disorder Opioid dependence Liver disease Patient refuse

Sites / Locations

Minia University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

lidocaine

control group

Arm Description

The patients will undergo shoulder arthroscopy with lidocaine epinephrine fluids irrigation.

The patients will undergo shoulder arthroscopy with epinephrine fluids irrigation only.

Outcomes

Primary Outcome Measures

total analgesic consumption

total nalbuphine consumed one day after surgery

Secondary Outcome Measures

first analgesic request

time of PCA request

Visual analogue pain score

pain intensity at rest and movement from 0-10 which 0 no pain and 10 the worst pain

Full Information

NCT ID

NCT05624957

First Posted

November 3, 2022

Last Updated

October 18, 2023

Sponsor

Minia University

1. Study Identification

Unique Protocol Identification Number

NCT05624957

Brief Title

Lidocaine Irrigation in Shoulder Arthroscopy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Completed

Study Start Date

November 25, 2022 (Actual)

Primary Completion Date

May 1, 2023 (Actual)

Study Completion Date

August 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Minia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Pain, Analgesia

Keywords

Postoperative pain, Lidocaine, Shoulder arthroscopy

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

lidocaine

Arm Type

Experimental

Arm Description

The patients will undergo shoulder arthroscopy with lidocaine epinephrine fluids irrigation.

Arm Title

control group

Arm Type

Placebo Comparator

Arm Description

The patients will undergo shoulder arthroscopy with epinephrine fluids irrigation only.

Intervention Type

Drug

Intervention Name(s)

Lidocaine epinephrine

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Epinephrin

Intervention Description

0.25 mg epinephrine mixed with one litre of fluid irrigation

Primary Outcome Measure Information:

Title

total analgesic consumption

Description

total nalbuphine consumed one day after surgery

Time Frame

24 hours

Secondary Outcome Measure Information:

Title

first analgesic request

Description

time of PCA request

Time Frame

24 hours

Title

Visual analogue pain score

Description

pain intensity at rest and movement from 0-10 which 0 no pain and 10 the worst pain

Time Frame

24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 20-60 Both genders Shoulder arthroscopy ASA I-III Exclusion Criteria: Drug allergy Psychiatric disorder Opioid dependence Liver disease Patient refuse

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

hassan m. hetta, lecturer

Organizational Affiliation

minia university/ faculty of medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Minia University Hospital

City

Minya

ZIP/Postal Code

61511

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Lidocaine Irrigation in Shoulder Arthroscopy

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