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Adding Ketamine to Levobupivacaine in Paravertebral Block in Thoracotomy

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ClinicalTrials.gov Identifier: NCT06011746
Recruitment Status : Completed
First Posted : August 25, 2023
Last Update Posted : February 13, 2024
Sponsor:
Information provided by (Responsible Party):
Mohammed Said ElSharkawy, Tanta University

Study Description
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Brief Summary:
To evaluate the role of adding ketamine to levobupivacaine in PVB on acute and chronic pain in thoracotomy

Condition or disease Intervention/treatment Phase
Ketamine Levobupivacaine Paravertebral Block Acute Pain Chronic Pain Drug: Ketamine + Levobupivacaine Drug: Levobupivacaine Phase 4

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Adding Ketamine to Levobupivacaine in Paravertebral Block on Acute and Chronic Pain in Thoracotomy: a Randomized Controlled Double-blinded Trial
Actual Study Start Date : August 30, 2023
Actual Primary Completion Date : January 26, 2024
Actual Study Completion Date : January 26, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain
Drug Information available for: Ketamine

Arms and Interventions
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Arm Intervention/treatment
Experimental: Ketamine Group
patients will receive paravertebral block (19 mL of 0.5% levobupivacaine + 1 ml ketamine (50 mg)).
 Drug: 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)
Active Comparator: Control Group
patients will receive paravertebral block (19 mL of 0.5% levobupivacaine + 1 ml normal saline)
 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


Outcome Measures
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Primary Outcome Measures :
  1. Time to first analgesia [ Time Frame: 24 hour postoperatively ]
    The time till the first rescue of analgesia of morphine. Patients can receive incremental doses of morphine 3 mg intravenously as rescue analgesia if the numeric rating scale (NRS) pain score is > 3.


Secondary Outcome Measures :
  1. Total amount of morphine consumption [ Time Frame: 24 hour postoperatively ]
    The total morphine consumption in the 1st 24h postoperative will be recorded. Patients can receive incremental doses of meperidine 0.5 mg/kg intravenously as rescue analgesia if the numeric rating scale (NRS) pain score is > 3.

  2. Pain intensity during rest [ Time Frame: 48 hour postoperatively ]
    Postoperative pain using numeric rating scale at rest and during coughing or movement will be measured at Post-anesthesia care unit, 1h, 2h. 4hr, 6h, 8h, 12h, 18h, 24h, 36h and 48h postoperative.

  3. Pain intensity during deep breathing [ Time Frame: 48 hour postoperatively ]
    Postoperative pain using numeric rating scale at rest and during coughing or movement will be measured at Post-anesthesia care unit, 1h, 2h. 4hr, 6h, 8h, 12h, 18h, 24h, 36h and 48h postoperative.

  4. Incidence of chronic pain [ Time Frame: three months postoperatively ]
    The neuropathic PTPS cases were screened using the grading system for neuropathic pain (GSNP). Positive cases of PTPS with a neuropathic component were grade 2 (probable) or 3 (definite), that is, GSNP ≥2


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06011746


Locations
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Egypt
Tanta University
Tanta, El-Gharbia, Egypt, 31527
Sponsors and Collaborators
Tanta University
More Information
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Responsible Party: Mohammed Said ElSharkawy, Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine Faculty of Medicine Tanta University, Tanta University
ClinicalTrials.gov Identifier: NCT06011746    
Other Study ID Numbers: 36264PR244/6/23
First Posted: August 25, 2023    Key Record Dates
Last Update Posted: February 13, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Supporting Materials: Study Protocol
Time Frame: after the end of study for one year.
Access Criteria: The data will be available upon a reasonable request from the corresponding author

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chronic Pain
Acute Pain
Pain
Neurologic Manifestations
Ketamine
Levobupivacaine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local