Pharmacokinetic of Thoracic Paravertebral Ropivacaine

Open Thoracotomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03721406
• Other study ID #: ROPICTPVB
• Status: Completed
• Phase: N/A
• Start date: October 8, 2019
• Est. completion date: November 25, 2021

Study information

• Verified date: February 2022
• Source: Attikon Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 25, 2021
• Est. primary completion date: October 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Open Thoracotomy

Intervention

Drug:
• Ropivacaine
ropivacaine administerd via thoracic paraveretebral catheter

Locations

Country	Name	City	State
Greece	2nd Department of Anesthesiology, Attikon University Hospital	Athens	Attiki
Greece	Paraskevi K Matsota	Athens	Other

Sponsors (1)

Lead Sponsor	Collaborator
Attikon Hospital

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	Clinical signs of local anesthetic toxicity	Cardiac arrythmia on ECG	Up to 72 hours after the initiation of continuous thoracic paravertebral infusion of ropivacaine