A Phase 4 interventional study of Ketamine + Levobupivacaine and Levobupivacaine in Ketamine, Levobupivacaine and Paravertebral Block, sponsored by Tanta University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-02-13.
Sponsored by Tanta University · Phase 4, Interventional, and Treatment
To evaluate the role of adding ketamine to levobupivacaine in PVB on acute and chronic pain in thoracotomy
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.
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Exclusion Criteria:
patients will receive paravertebral block (19 mL of 0.5% levobupivacaine + 1 ml ketamine (50 mg)).
Drug: Ketamine + Levobupivacaine
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 1ml ketamine (50mg)
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
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
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.
Time frame: 24 hour postoperatively
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.
Time frame: 48 hour postoperatively
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.
Time frame: 48 hour postoperatively
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
Time frame: three months postoperatively
Plan to share: Yes — The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Supporting information: Study protocol
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Tanta University