Adding Ketamine to Levobupivacaine in Paravertebral Block in Thoracotomy

NCT06011746 | Completed Phase 4 DMC

• 1 other identifier: 36264PR244/6/23
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ketamine; Levobupivacaine; Paravertebral Block; Acute Pain; Chronic Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Total amount of morphine consumption

  24 hour postoperatively

• Pain intensity during rest

  48 hour postoperatively

• Pain intensity during deep breathing

  48 hour postoperatively

• Incidence of chronic pain

  three months postoperatively

Study Arms (2)

Ketamine Group

EXPERIMENTAL

patients will receive paravertebral block (19 mL of 0.5% levobupivacaine + 1 ml ketamine (50 mg)).

Drug: Ketamine + Levobupivacaine

Control Group

ACTIVE COMPARATOR

patients will receive paravertebral block (19 mL of 0.5% levobupivacaine + 1 ml normal saline)

Drug: Levobupivacaine

Interventions

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)

Ketamine Group

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

Control Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years.
• Both sexes.
• ASA (American Society of Anesthesiology) physical status II-III.
• Scheduled for open thoracotomy.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

MeSH Terms

Conditions

Acute Pain; Chronic Pain

Interventions

Ketamine; Levobupivacaine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Bupivacaine; Anilides; Amides; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine Faculty of Medicine Tanta University

Study Record Dates

• First Submitted: July 13, 2023
• First Posted: August 25, 2023
• Study Start: August 30, 2023
• Primary Completion: January 26, 2024
• Study Completion: January 26, 2024
• Last Updated: February 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: after the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author

Locations

EG (1)