Ketamine and Magnesium in Erector Spinae Plane Block

Sponsor

Cukurova University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05855798

Collaborator

(none)

Enrollment

Location

Arms

1.9

Anticipated Duration (Months)

31.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Analgesia	Drug: Bupivacain Drug: Magnesium sulfate Drug: Ketamine Hydrochloride	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

May 10, 2023

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Jul 7, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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