Ketamine and Magnesium in Erector Spinae Plane Block

Postoperative Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05855798
• Other study ID #: ESP
• Status: Completed
• Phase: Phase 4
• Start date: May 10, 2023
• Est. completion date: October 2, 2023

Study information

• Verified date: November 2023
• Source: Cukurova University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2, 2023
• Est. primary completion date: October 2, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Postoperative Analgesia

Intervention

Drug:
• Bupivacain
Bupivacaine is a local anesthetic agent commonly used in ESP block.
• Magnesium sulfate
Magnesium is an adjuvant agent that can be added to the local anesthetic agent to increase analgesic effectiveness..
• Ketamine Hydrochloride
Ketamine Hydrochloride is an also adjuvant agent that can be added to the local anesthetic to increase analgesic effectiveness.

Locations

Country	Name	City	State
Turkey	Cukurova University	Adana

Sponsors (1)

Lead Sponsor	Collaborator
Cukurova University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	side effects	All of patients will visited in the thoracic surgery ward after surgery and side effects (if occured) will recorded.	postoperative 24 hours