Adding Ketamine to Levobupivacaine in Paravertebral Block in Thoracotomy

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

2023-08-30

Study Completion Date

2024-01-26

Brief Summary

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To evaluate the role of adding ketamine to levobupivacaine in PVB on acute and chronic pain in thoracotomy

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Detailed Description

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Several adjuvants have been added to them to enhance the effects of those blocks. Dexamethasone, morphine, dexmedetomidine, clonidine, ketamine, and magnesium sulphate are some of them. results are variable.

Ketamine blocks N-Methyl-D-Aspartate (NMDA) receptors in the spinal cord. It is also considered to influence voltage sensitive Calcium ions channels, opioid receptors, and monoaminergic receptors. Therefore, it is considered overall to affect nociception.

Conditions

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Ketamine Levobupivacaine Paravertebral Block Acute Pain Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Ketamine Group

patients will receive paravertebral block (19 mL of 0.5% levobupivacaine + 1 ml ketamine (50 mg)).

Group Type EXPERIMENTAL

Ketamine + Levobupivacaine

Intervention Type DRUG

Skin infiltration will be done using 3 ml lidocaine 2% and a 22-gauage block needle will be advanced using the in-plane approach craniocaudally. Once the costotransverse ligament is reached, negative aspiration of blood and air will be confirmed. Under ultrasound visualization, 19 mL of 0.5% levobupivacaine with 1ml ketamine (50mg)

Control Group

patients will receive paravertebral block (19 mL of 0.5% levobupivacaine + 1 ml normal saline)

Group Type ACTIVE_COMPARATOR

Levobupivacaine

Intervention Type DRUG

Skin infiltration will be done using 3 ml lidocaine 2% and a 22-gauage block needle will be advanced using the in-plane approach craniocaudally. Once the costotransverse ligament is reached, negative aspiration of blood and air will be confirmed. Under ultrasound visualization, 19 mL of 0.5% levobupivacaine with (50mg) or normal saline

Interventions

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Ketamine + Levobupivacaine

Skin infiltration will be done using 3 ml lidocaine 2% and a 22-gauage block needle will be advanced using the in-plane approach craniocaudally. Once the costotransverse ligament is reached, negative aspiration of blood and air will be confirmed. Under ultrasound visualization, 19 mL of 0.5% levobupivacaine with 1ml ketamine (50mg)

Intervention Type DRUG

Levobupivacaine

Skin infiltration will be done using 3 ml lidocaine 2% and a 22-gauage block needle will be advanced using the in-plane approach craniocaudally. Once the costotransverse ligament is reached, negative aspiration of blood and air will be confirmed. Under ultrasound visualization, 19 mL of 0.5% levobupivacaine with (50mg) or normal saline

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age 18-75 years.
* Both sexes.
* ASA (American Society of Anesthesiology) physical status II-III.
* Scheduled for open thoracotomy.

Exclusion Criteria

* Contraindications to or failed paravertebral block .
* Body mass index (BMI) \>35 kg/m2.
* The likelihood of postoperative mechanical ventilation.
* Patients with coagulopathy, poorly controlled diabetes mellitus, depression or other psychiatric disorders that required antidepressant drugs, alcohol, or recreational drug addiction.
* Hypersensitivity to ketamine or levobupivacaine.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No