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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06011746
Other study ID # 36264PR244/6/23
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date August 30, 2023
Est. completion date January 26, 2024

Study information

Verified date February 2024
Source Tanta University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date January 26, 2024
Est. primary completion date January 26, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Intervention

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)
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

Locations

Country Name City State
Egypt Tanta University Tanta El-Gharbia

Sponsors (1)

Lead Sponsor Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 24 hour postoperatively
Secondary 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. 24 hour postoperatively
Secondary 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. 48 hour postoperatively
Secondary 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. 48 hour postoperatively
Secondary 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 three months postoperatively
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