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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ketamine Levobupivacaine Paravertebral Block Acute Pain Chronic Pain | Drug: Ketamine + Levobupivacaine Drug: Levobupivacaine | Phase 4 |
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 : | 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 |
Arm | Intervention/treatment |
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Experimental: Ketamine Group
patients will receive paravertebral block (19 mL of 0.5% levobupivacaine + 1 ml ketamine (50 mg)).
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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)
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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 |
- 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.
- 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.
- 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.
- 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.
- 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
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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 |
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.
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
Egypt | |
Tanta University | |
Tanta, El-Gharbia, Egypt, 31527 |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
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 |