Adding Ketamine to Levobupivacaine in Paravertebral Block in Thoracotomy

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06011746
• Other study ID #: 36264PR244/6/23
• Status: Completed
• Phase: Phase 4
• 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
• 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.

Related Conditions & MeSH terms

• Acute Pain
• Chronic Pain
• Ketamine
• Levobupivacaine
• Paravertebral Block

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