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Clinical trial

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

ID
Name
475:10/2022
Description
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.
Trial arms
Trial start
2022-11-25
Estimated PCD
2023-05-01
Trial end
2023-08-01
Status
Completed
Treatment
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.
Arms:
lidocaine
Epinephrin
0.25 mg epinephrine mixed with one litre of fluid irrigation
Arms:
control group
Size
50
Primary endpoint
total analgesic consumption
24 hours
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 50, 'type': 'ACTUAL'}}
Updated at
2023-10-19

1 organization

2 products

2 indications

Organization
Minia University
Product
Lidocaine Epinephrine
Indication
Postoperative Pain
Indication
Analgesic
Product
Epinephrin