Clinical trial

Comparison of Analgesic Effects of Magnesium Sulphate and Ketamine Added to 0.5% Bupivacaine for Erector Spinae Plane Block in Patients Undergoing Video-assisted Thoracoscopic Surgery

Name

ESP

Description

In this study, it will aimed to evaluate the effect of magnesium sulfate and ketamine HCl added to local anesthetic on postoperative pain management in the ultrasound-guided erector spina plane (ESP) block in patients will undergo video-assisted thoracoscopic surgery.

Trial arms

Trial start

2023-05-10

Estimated PCD

2023-10-02

Trial end

2023-10-02

Status

Completed

Phase

Early phase I

Treatment

Bupivacain

Bupivacaine is a local anesthetic agent commonly used in ESP block.

Arms:

control group, ketamine group, magnesium group

Magnesium sulfate

Magnesium is an adjuvant agent that can be added to the local anesthetic agent to increase analgesic effectiveness..

Arms:

magnesium group

Ketamine Hydrochloride

Ketamine Hydrochloride is an also adjuvant agent that can be added to the local anesthetic to increase analgesic effectiveness.

Arms:

ketamine group

Size

Primary endpoint

pain scores

Change from baseline pain scores at 24 hours

morphine consumption

Change from baseline morphine consumption at 24 hours

Eligibility criteria

Inclusion Criteria: * lung resection with video-assisted thoracoscopy, * voluntarily agree to participate in the study, * over 18 years old, * ASA I-III Exclusion Criteria: * ASA\>III * Coagulation disorders or anticoagulant agent therapy, * Allergy or hypersensitivity to any drug to be will be used in the study, * Epilepsy, * High intracranial pressure, * Unwillingness to participate in the study * Inability to use the PCA device

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}

Updated at

2023-11-03

1 organization

2 products

1 drug

1 indication

Organization

Cukurova University

Product

Bupivacain

Indication

Postoperative Analgesia

Product

Magnesium sulfate

Drug

Ketamine