Peak Plasma Levels of Bupivacaine After an Erector Spinae Block (ESP)

NCT03841409 | Completed

• 1 other identifier: 18.308
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the study is to measure plasma levels of bupivacaine following erector spinae (ESP) regional block in patients undergoing mastectomy.

Conditions

Pharmacokinetics; Anesthesia, Local

Outcome Measures

Primary Outcomes (1)

• Maximal plasma concentration (Cmax) of bupivacaine after erector spinae block

  The Cmax will be estimated by interpolation based on the plasmatic bupivacaine values obtained after the analysis of the blood samples.

  The end of injection of bupivacaine will be considered as T0. Blood samples at T10, T20, T30, T45, T60, T90, T120, T180, and T240minutes will be collected to further analyze plasmatic bupivacaine values at these timepoints.

Secondary Outcomes (4)

• Time (Tmax) to maximum plasma concentration Cmax of bupivacaine

  The end of injection of bupivacaine will be considered as T0. Blood samples at T10, T20, T30, T45, T60, T90, T120, T180, and T240minutes will be performed to further analyze plasmatic bupivacaine values at these timepoints.

• Sensory block level 30 minutes after arriving to Post-Anesthesia Care Unit

  30 minutes after arriving to Post-Anesthesia Care Unit

• Post-operative pain using verbal numerical rating scale

  30 minutes after arriving to Post-Anesthesia Care Unit

• Total opioid dose needed during Post-Anesthesia Care Unit stay (PACU)

  After the surgery, from the entry in the Post-Anesthesia Care Unit to the discharge from the Post-Anesthesia Care Unit, for an average of one-hour stay.

Study Arms (1)

Bupivacaine dosage in ESP block

The pharmacokinetics of bupivacaine 0.5% with epinephrine 5 mcg/mL for a total dose of 2mg/kg of ideal body weight following an ESP block will be determined by the collection of blood samples at predetermined time points.

Other: Collection of blood samples

Interventions

Collection of blood samples OTHER

Nine blood samples will be collected to determine bupivacaine pharmacokinetics at T10min, T20min, T30min, T45min, T60min, T90min, T120min, T180min, and T240min. T0 will be defined as the end of bupivacaine injection.

Bupivacaine dosage in ESP block

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing unilateral mastectomy under general anesthesia and erector spinae block for post-operative pain management.

You may qualify if:

• ASA I-III
• Undergoing unilateral mastectomy under erector spinae block and general anesthesia

You may not qualify if:

• Patient's refusal or inability to consent
• Allergy, hypersensibility or resistance to local anesthetic
• Contra-indication to regional anesthesia: infection in the designated area, acquired or congenital coagulopathy
• Severe hepatic or renal insufficiency (GFR\<30 mL/min)

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X 3E4, Canada

Location

Study Officials

• Stephan Williams, MD, PhD

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2019
• First Posted: February 15, 2019
• Study Start: June 14, 2019
• Primary Completion: October 16, 2019
• Study Completion: October 16, 2019
• Last Updated: May 31, 2022

Record last verified: 2021-07

Locations

CA (1)