Ketamine and Magnesium in Erector Spinae Plane Block

NCT05855798 | Completed Phase 4

• 1 other identifier: esp01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Analgesia

Keywords

erector spinae plane block; magnesium sulphate; ketamine HCl; bupivacaine; analgesia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• side effects

  postoperative 24 hours

Study Arms (3)

control group

ACTIVE COMPARATOR

Erector spinae plane block with 20 mL 0.5% bupivacaine

Drug: Bupivacain

magnesium group

ACTIVE COMPARATOR

Erector spinae plane block with 20 mL 0.5% bupivacaine+150 mg magnesium sulphate

Drug: Bupivacain; Drug: Magnesium sulfate

ketamine group

ACTIVE COMPARATOR

Erector spinae plane block with 20 mL 0.5% bupivacaine+2 mg/kg ketamine

Drug: Bupivacain; Drug: Ketamine Hydrochloride

Interventions

Bupivacain DRUG

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

control group; ketamine group; magnesium group

Magnesium sulfate DRUG

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

magnesium group

Ketamine Hydrochloride DRUG

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

ketamine group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• lung resection with video-assisted thoracoscopy,
• voluntarily agree to participate in the study,
• over 18 years old,
• ASA I-III

You may not qualify if:

• 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

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Cukurova University

Adana, Adana, 01330, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Agnosia

Interventions

Bupivacaine; Magnesium Sulfate; Ketamine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: May 11, 2023
• Study Start: May 10, 2023
• Primary Completion: October 2, 2023
• Study Completion: October 2, 2023
• Last Updated: September 19, 2024

Record last verified: 2023-11

Locations

TU (1)