Back to resultsAdding Ketamine to Levobupivacaine in Paravertebral Block in Thoracotomy
Primary Purpose
Ketamine, Levobupivacaine, Paravertebral Block
Status
Recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Ketamine + Levobupivacaine
Levobupivacaine
Sponsored by
About this trial
This is an interventional treatment trial for Ketamine
Eligibility 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.
Sites / Locations
- Tanta UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ketamine Group
Control Group
Arm Description
patients will receive paravertebral block (19 mL of 0.5% levobupivacaine + 1 ml ketamine (50 mg)).
patients will receive paravertebral block (19 mL of 0.5% levobupivacaine + 1 ml normal saline)
Outcomes
Primary Outcome Measures
Time to first analgesia
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
Total amount of morphine consumption
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.
Pain intensity during rest
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.
Pain intensity during deep breathing
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.
Incidence of chronic pain
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06011746
Brief Title
Adding Ketamine to Levobupivacaine in Paravertebral Block in Thoracotomy
Official Title
Efficacy of Adding Ketamine to Levobupivacaine in Paravertebral Block on Acute and Chronic Pain in Thoracotomy: a Randomized Controlled Double-blinded Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 30, 2023 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To evaluate the role of adding ketamine to levobupivacaine in PVB on acute and chronic pain in thoracotomy
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ketamine, Levobupivacaine, Paravertebral Block, Acute Pain, Chronic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ketamine Group
Arm Type
Experimental
Arm Description
patients will receive paravertebral block (19 mL of 0.5% levobupivacaine + 1 ml ketamine (50 mg)).
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
patients will receive paravertebral block (19 mL of 0.5% levobupivacaine + 1 ml normal saline)
Intervention Type
Drug
Intervention Name(s)
Ketamine + Levobupivacaine
Intervention Description
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
Intervention Name(s)
Levobupivacaine
Intervention Description
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
Primary Outcome Measure Information:
Title
Time to first analgesia
Description
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.
Time Frame
24 hour postoperatively
Secondary Outcome Measure Information:
Title
Total amount of morphine consumption
Description
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.
Time Frame
24 hour postoperatively
Title
Pain intensity during rest
Description
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.
Time Frame
48 hour postoperatively
Title
Pain intensity during deep breathing
Description
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.
Time Frame
48 hour postoperatively
Title
Incidence of chronic pain
Description
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
Time Frame
three months postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Tanta University
City
Tanta
State/Province
El-Gharbia
ZIP/Postal Code
31527
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammed S Elsharkawy
Phone
+20 114 820 7870
Email
mselsharkawy@med.tanta.edu.eg
First Name & Middle Initial & Last Name & Degree
Saad A Moharam, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
Adding Ketamine to Levobupivacaine in Paravertebral Block in Thoracotomy
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