Ketamine and Magnesium in Erector Spinae Plane Block

NCT ID: NCT05855798

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-10

Study Completion Date

2023-10-02

Brief Summary

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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

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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.

Conditions

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Postoperative Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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control group

Erector spinae plane block with 20 mL 0.5% bupivacaine

Group Type ACTIVE_COMPARATOR

Bupivacain

Intervention Type DRUG

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

magnesium group

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

Group Type ACTIVE_COMPARATOR

Bupivacain

Intervention Type DRUG

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

Magnesium sulfate

Intervention Type DRUG

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

ketamine group

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

Group Type ACTIVE_COMPARATOR

Bupivacain

Intervention Type DRUG

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

Ketamine Hydrochloride

Intervention Type DRUG

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

Interventions

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Bupivacain

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

Intervention Type DRUG

Magnesium sulfate

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

Intervention Type DRUG

Ketamine Hydrochloride

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cukurova University

OTHER

Sponsor Role lead

Responsible Party

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mediha turktan

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cukurova University

Adana, Adana, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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esp01

Identifier Type: -

Identifier Source: org_study_id

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