Pharmacokinetic of Thoracic Paravertebral Ropivacaine

The Pharmacokinetic of Ropivacaine in Patients Undergoing Ultrasound-guided Continuous Thoracic Paravertebral Block

The study aims to investigate the pharmacokinetic of ropivacaine in patients undergoing ultrasound guided thoracic paravertebral block (TPVB) both after a single-bolus injection via the thoracic paravertebral catheter given before the start of surgery and after continuous thoracic paravertebral infusion that will start after the end of the procedure in order to achieve postoperative analgesia after open thoracotomy during the first 3 postoperative days

Study Overview

• Status: Completed
• Conditions: Open Thoracotomy
• Intervention / Treatment: Drug: Ropivacaine

Detailed Description

Patients aged >18yrs, of ASA I-III undergoing open thoracotomy under combined ultrasound guided thoracic paravertebral block (TPVB) and general anesthesia will be enrolled in the study.

TPVB will be performed under ultrasound guidance on the side of the operation immediately after induction of anesthesia and patient intubation, with the patient in the lateral position at the T5 or T6 or T7 thoracic level using a Tuohy 17G needle and the catheter will be advanced 5 cm beyond the point of needle tip.

Dosage regimen Initially, after catheter placement and control, 0.5% ropivacaine is administered via the catheter in a 25 ml single dose, before the start of surgery.

After the end of surgery and patient awakening, the catheter will be connected with an electronic pump and the continuous infusion of ropivacaine 0.2% will start with a constant infusion rate of 14 ml/h for the first 3 postoperative days.

Postoperative pain will be assessed using the Visual Analogue Scale (VAS: 0-10). Postoperative analgesia will be managed with continuous PVB, and systemic administration of paracetamol (1 gr X 4 iv), tramadol (100 mg x 3 iv) and pregabalin (75 mg x 2 pos). Additionally, if VAS is ≥4-5 morphine (2.5 -5mg) will be administered subcutaneously as rescue analgesic drug (max 6 doses/day). In case of persistent pain (VAS > 4-5) despite the previously mentioned treatment measures, PCA morphine will be used.

Postoperative data include arterial blood pressure, heart rate, SpO2, VAS scores, clinical signs of local anesthetic toxicity during the first 3 postoperative days, specifically at 12, 24, 36, 48 and 72 postoperative hours.

Samples Serial blood samples from radial artery and central venous line will be collected at predefined time points, as following.

After the single-dose paravertebral injection Serial blood samples from radial artery will be collected at 5, 7.5, 10, 15, 20, end of surgery (min) Serial blood samples from central venous line will be collected at 1, 5, 7.5, 10, 15, 20, 40, 60, end of surgery (min)

After the initiation of continuous paravertebral infusion Serial blood samples from radial artery will be collected at 2.5, 7.5, 15, 30, 60 (min) and afterwards at 24, 48, 72 (hours) Serial blood samples from central venous line will be collected at 2.5, 10, 15, 30, 60 (min) and afterwards at 2, 6, 24, 48, 72 (hours)

Determination of ropivacaine plasma levels samples collected at regular intervals. All blood samples (2.5ml) will be placed into EDTA vacutainer tubes and immediately centrifuged (3,500rpm, 10min) after which the plasma will be Ropivacaine plasma levels will be measured in both arterial and venous blood removed. Plasma samples will be stored at -70 ° C until assayed. Bioassay of blood samples will be performed according to Good Laboratory Practice.

Measurement of ropivacaine plasma concentrations Quantification of total ropivacaine plasma levels in blood samples (sample volume 1mL) will be performed by high performance liquid chromatography (HPLC), using the method developed by Gaudreault F, Drolet P and Varin F (2009)

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Attiki
    • Athens, Attiki, Greece, 12462
      • 2nd Department of Anesthesiology, Attikon University Hospital
  • Other
    • Athens, Other, Greece, 13231
      • Paraskevi K Matsota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age >18 years
• ASA I-III
• Open thoracotomy

Exclusion Criteria:

• Patient refusal
• Age <18 years
• Morbid obesity
• Scoliosis
• Previous thoracotomy
• Empyema
• Drug allergy
• Severe systemic disease
• ASA > III
• Hypoalbuminemia
• Urgent surgery
• Reoperation during the study period

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Ropivacaine; 25 ml single dose of 0.5% ropivacaine; continuous infusion of ropivacaine 0.2% with a constant infusion rate of 14 ml/h	Drug: Ropivacaine; ropivacaine administerd via thoracic paraveretebral catheter; Other Names: thoracic paravertebral block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ropivacaine plasma levels	Ropivacaine plasma levels in both arterial and venous blood samples collected at regular intervals	up to 72 postoperative hours after the initiation of continuous thoracic paravertebral infusion of ropivacaine

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical signs of local anesthetic toxicity	Cardiac arrythmia on ECG	Up to 72 hours after the initiation of continuous thoracic paravertebral infusion of ropivacaine

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS scores	Postoperative pain will be assessed using the Visual Analogue Scale (0-10cm, 0=no pain, 10=the worst pain)	up to 72 postoperative hours after the initiation of continuous thoracic paravertebral infusion of ropivacaine

Collaborators and Investigators

• Sponsor: Attikon Hospital
• Investigators: Principal Investigator: Paraskevi K Matsota, Prof, 2nd Department of Anaesthesiology, "Attikon" University Hospital, Athens

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2019
• Primary Completion (Actual): October 25, 2021
• Study Completion (Actual): November 25, 2021

Study Registration Dates

• First Submitted: October 23, 2018
• First Submitted That Met QC Criteria: October 25, 2018
• First Posted (Actual): October 26, 2018

Study Record Updates

• Last Update Posted (Actual): February 16, 2022
• Last Update Submitted That Met QC Criteria: February 15, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: ropivacaine; undergoing ultrasound guided thoracic paravertebral block
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: ROPICTPVB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No