Adding Ketamine to Levobupivacaine in Paravertebral Block in Thoracotomy

February 10, 2024 updated by: Mohammed Said ElSharkawy, Tanta University

Efficacy of Adding Ketamine to Levobupivacaine in Paravertebral Block on Acute and Chronic Pain in Thoracotomy: a Randomized Controlled Double-blinded Trial

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • El-Gharbia
      • Tanta, El-Gharbia, Egypt, 31527
        • Tanta University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
24 hour postoperatively

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
24 hour postoperatively
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.
48 hour postoperatively
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.
48 hour postoperatively
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
three months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 30, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 26, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 26, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 13, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 25, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 13, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 36264PR244/6/23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

IPD Sharing Time Frame

after the end of study for one year.

IPD Sharing Access Criteria

The data will be available upon a reasonable request from the corresponding author

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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