Ketamine and Magnesium in Erector Spinae Plane Block

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Analgesia
• Intervention / Treatment: Drug: Bupivacain; Drug: Magnesium sulfate; Drug: Ketamine Hydrochloride

Detailed Description

Patients who will undergo lung resection with elective video-assisted thoracoscopic surgery will be included in the study. After routine monitoring, general anesthesia induction, and intubation with a double-lumen tube, patients who are placed in a lateral position will receive an ESP block at the T5 level, accompanied by ultrasonography, for postoperative analgesia.

For this purpose; Group I (control group) 0.5% bupivacaine 20 ml, Group II 0.5% bupivacaine 20 ml+150 mg MgSO4, Group III 0% ,5 bupivacaine 20 ml+2 mg/kg ketamine HCl will be administered. In all groups, the total volume will completed to 25 ml with 0.9% NaCl.

After surgery, hemodynamic values (heart rate, systolic and diastolic blood pressure), oxygen saturation, VAS scores (at rest and effort), Ramsey sedation score, patients satisfaction scores, PCA morphine consumption, additional analgesic requirements, and side effects will be recorded.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Adana, Turkey, 01330
    • Çukurova University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control group; Erector spinae plane block with 20 mL 0.5% bupivacaine	Drug: Bupivacain; Bupivacaine is a local anesthetic agent commonly used in ESP block.
Active Comparator: magnesium group; Erector spinae plane block with 20 mL 0.5% bupivacaine+150 mg magnesium sulphate	Drug: Bupivacain; Bupivacaine is a local anesthetic agent commonly used in ESP block.; Drug: Magnesium sulfate; Magnesium is an adjuvant agent that can be added to the local anesthetic agent to increase analgesic effectiveness..
Active Comparator: ketamine group; Erector spinae plane block with 20 mL 0.5% bupivacaine+2 mg/kg ketamine	Drug: Bupivacain; Bupivacaine is a local anesthetic agent commonly used in ESP block.; Drug: Ketamine Hydrochloride; Ketamine Hydrochloride is an also adjuvant agent that can be added to the local anesthetic to increase analgesic effectiveness.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain scores	postoperative pain scores will recorded used Visual Analog Scale (VAS, 0= no pain, 10=worst pain)	Change from baseline pain scores at 24 hours
morphine consumption	At the end of the surgery, patients will allowed to use the patient controlled analgesia (PCA) device. The PCA will deliver bolus doses of morphine (0,02 mg/kg) every 10 minutes without a background infusion.	Change from baseline morphine consumption at 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
side effects	All of patients will visited in the thoracic surgery ward after surgery and side effects (if occured) will recorded.	postoperative 24 hours

Collaborators and Investigators

• Sponsor: Cukurova University

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2023
• Primary Completion (Actual): October 2, 2023
• Study Completion (Actual): October 2, 2023

Study Registration Dates

• First Submitted: May 4, 2023
• First Submitted That Met QC Criteria: May 4, 2023
• First Posted (Actual): May 11, 2023

Study Record Updates

• Last Update Posted (Actual): November 3, 2023
• Last Update Submitted That Met QC Criteria: November 2, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: analgesia; bupivacaine; magnesium sulphate; erector spinae plane block; ketamine HCl
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Membrane Transport Modulators; Anticonvulsants; Anesthetics, Local; Calcium-Regulating Hormones and Agents; Reproductive Control Agents; Calcium Channel Blockers; Tocolytic Agents; Ketamine; Bupivacaine; Magnesium Sulfate
• Other Study ID Numbers: ESP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No