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Completed

NCT Number: NCT06011746

Adding Ketamine to Levobupivacaine in Paravertebral Block in Thoracotomy

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

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Key information

Conditions

Ketamine Acute Pain Chronic Pain Levobupivacaine Neurologic Manifestations Pain Paravertebral Block Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ketamine + Levobupivacaine

Drug

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

Drug

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

Primary outcomes

  1. Time to first analgesia

    Time frame: 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 outcomes

  1. Total amount of morphine consumption

    Time frame: 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.

  2. Pain intensity during rest

    Time frame: 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.

  3. Pain intensity during deep breathing

    Time frame: 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.

  4. Incidence of chronic pain

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 25, 2023
Registry last updated
Feb 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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