Adding Ketamine to Levobupivacaine in Paravertebral Block in Thoracotomy

Tanta University60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Ketamine Levobupivacaine Paravertebral Block Acute Pain Chronic Pain

Interventions

Ketamine + LevobupivacaineDRUG

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)

LevobupivacaineDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Tanta University

Tanta, El-Gharbia, Egypt

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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