Ketamine and Magnesium in Erector Spinae Plane Block

Phase 4

Completed

• Conditions: Postoperative Analgesia
• Interventions: Drug: Bupivacain; Drug: Ketamine Hydrochloride; Drug: Magnesium sulfate

• Registration Number: NCT05855798
• Lead Sponsor: Cukurova University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2023-05-04
• Study First Submitted QC: 2023-05-04
• Study Start: 2023-05-10
• Study First Posted: 2023-05-11
• Primary Completion: 2023-10-02
• Study Completion: 2023-10-02
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-02
• Last Update Posted: 2023-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
magnesium group	Bupivacain	Erector spinae plane block with 20 mL 0.5% bupivacaine+150 mg magnesium sulphate
control group	Bupivacain	Erector spinae plane block with 20 mL 0.5% bupivacaine
ketamine group	Bupivacain	Erector spinae plane block with 20 mL 0.5% bupivacaine+2 mg/kg ketamine
ketamine group	Ketamine Hydrochloride	Erector spinae plane block with 20 mL 0.5% bupivacaine+2 mg/kg ketamine
magnesium group	Magnesium sulfate	Erector spinae plane block with 20 mL 0.5% bupivacaine+150 mg magnesium sulphate

Primary Outcome Measures

Name	Time	Method
pain scores	Change from baseline pain scores at 24 hours	postoperative pain scores will recorded used Visual Analog Scale (VAS, 0= no pain, 10=worst pain)
morphine consumption	Change from baseline morphine consumption at 24 hours	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cukurova University; 🇹🇷 Adana, Turkey