Adding Ketamine to Levobupivacaine in Paravertebral Block in Thoracotomy

Phase 4

Completed

• Conditions: Ketamine; Levobupivacaine; Paravertebral Block; Acute Pain; Chronic Pain
• Interventions: Drug: Ketamine + Levobupivacaine; Drug: Levobupivacaine

• Registration Number: NCT06011746
• Lead Sponsor: Tanta University

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.

Study Timeline

• Study First Submitted: 2023-07-13
• Study First Submitted QC: 2023-08-23
• Study First Posted: 2023-08-25
• Study Start: 2023-08-30
• Primary Completion: 2024-01-26
• Study Completion: 2024-01-26
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-10
• Last Update Posted: 2024-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketamine Group	Ketamine + Levobupivacaine	patients will receive paravertebral block (19 mL of 0.5% levobupivacaine + 1 ml ketamine (50 mg)).
Control Group	Levobupivacaine	patients will receive paravertebral block (19 mL of 0.5% levobupivacaine + 1 ml normal saline)

Primary Outcome Measures

Name	Time	Method
Time to first analgesia	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.

Secondary Outcome Measures

Name	Time	Method
Total amount of morphine consumption	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	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	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	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

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El-Gharbia, Egypt