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PK/PD Levobupivacaine With and Without Epinephrine After Ultrasound Guided ESP Block

Primary Purpose

Anesthetics Complications, Anesthetic Toxicity, Bupivacaine Overdose

Status
Unknown status
Phase
Phase 4
Locations
Chile
Study Type
Interventional
Intervention
Levobupivacaine 0.25% with epinephrine 5 ug/ml
Levobupivacaine 0.25% without epinephrine 5 ug/ml
Sponsored by
Pontificia Universidad Catolica de Chile
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anesthetics Complications focused on measuring ESP, Perioperative Care, Bupivacaine Overdose, VATS surgery

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Indication of VATS
  • ASA I-II
  • Body mass index (BMI) 20-34 kg / m2

Exclusion Criteria:

  • Patients with conversion to thoracotomy
  • History of chronic pain
  • Drug abuse
  • Psychiatric illness
  • Allergic to some of the drugs used in the study
  • Chronic analgesic users
  • History of peripheral neuropathy
  • Who refuse the procedure

Sites / Locations

  • Pontificia Universidad Catolica de ChileRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group I Epi

Group II no Epi

Arm Description

The ESP will be performed under ultrasound vision at T5 level, with the patient seated. Once the ultrasound image is achieved, a 100 mm, 20 G Stimuplex needle will be punctured and a solution of levobupivacaine 0.25% with epinephrine 5 ug/ml completing a volume of 20 ml.

The ESP will be performed under ultrasound vision at T5 level, with the patient seated. Once the ultrasound image is achieved, a 100 mm, 20 G Stimuplex needle will be punctured and a solution of levobupivacaine 0.25% without epinephrine completing a volume of 20 ml.

Outcomes

Primary Outcome Measures

Plasma levels of levobupivacaine
Levobupivacaine plasma levels will be measured using High-performance liquid chromatography.
Changes in plasma levels levobupivacaine of the group I v/s group II
To assess the changes in plasma levels of the group I with epinephrine versus the group II without epinephrine.
Sensitive skin extension
Determine the sensitive skin extension of ESP after its performance using pinprick and temperature discrimination using an alcohol swab.

Secondary Outcome Measures

Pain measured
Pain measured by Verbal Numerical Scale (VNS) 0 to 10. 0 = no pain. 10 = worse pain.
Heart Rate
Heart rate (bpm)
Hemodynamics
Invasive arterial pressure (mmHg)
Pulse oximetry
% oximetry saturation
Consumption of morphine or its equivalents
Consumption of morphine or its equivalents (mg/kg/hr)

Full Information

First Posted
March 11, 2021
Last Updated
March 15, 2021
Sponsor
Pontificia Universidad Catolica de Chile
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1. Study Identification

Unique Protocol Identification Number
NCT04799184
Brief Title
PK/PD Levobupivacaine With and Without Epinephrine After Ultrasound Guided ESP Block
Official Title
Pharmacokinetics and Pharmacodynamics for Levobupivacaine With and Without Epinephrine After Ultrasound Guided Erector Spinae Plane Block
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 3, 2019 (Actual)
Primary Completion Date
August 1, 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pontificia Universidad Catolica de Chile

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Currently there is no standardized management or single technique to manage postoperative pain after Video-assisted thoracic surgery (VATS), there are many options available ranging from intravenous opioids, morphine or fentanyl Patient-controlled analgesia (PCA), peripheral nerve blocks, intercostals, paravertebral and epidural blocks. Erector Spinal Block (ESP), this blocks the ventral and dorsal branch of the unilateral thoracic roots. It corresponds to an interfacial block that produces an extensive multidermatomal sensitive block with a single puncture, covering the anterior, lateral and posterior aspect of the thorax. One of its main advantages would be safety, possible less damage to nerves and pneumothorax, as well as the simplicity of execution of this block. What has positioned it as another analgesic alternative in this type of surgery. The pharmacokinetic profile that local anesthetics would have when injected into this interfacial compartment has not yet been described, and what the real impact of the use of vasoconstrictor will be in terms of plasma levels and duration of the block. Our objective is to compare the plasma levels of levobupivacaine achieved after performing an ESP Block with or without epinephrine.
Detailed Description
Video-assisted thoracic surgery (VATS) is one of the most common procedures performed in thoracic surgery, mainly because it has made it possible to solve many pathologies that previously required a thoracotomy with all the complications that that meant. VATS has been shown to be beneficial for patients, for many reasons such as lower mortality, better postoperative lung function, and shorter stay during hospitalization. Less invasive procedures such as VATS, where the surgical incision is small and avoids costal resection, produces less postoperative pain when compared to a thoracotomy, this has been objectified by numerous studies that have found lower scores on the numerical verbal scale (NVE) and fewer requirements for pain relievers. Despite the fact that VATS produces less acute postoperative pain (VNS 4-5 on the first postoperative day in VATS vs VNS 6 in thoracotomies), the incidence of chronic postoperative pain ranges from 20 to 47%, which is comparable to thoracotomy, mainly due to damage to the intercostal nerves and inadequate analgesia. It has been seen that one of the factors associated with the appearance of chronic pain after chest surgery is severe acute pain in the first three postoperative days. Acute pain in VATS is caused by surgical trauma to muscular and bone structures of the thorax, achieving good analgesia is important to maintain adequate respiratory function and avoid complications such as atelectasis, hypoxemia and possible pneumonia. Currently, there is no standardized management or single technique to manage postoperative pain after VATS, there are many options available ranging from intravenous opioids, morphine or fentanyl Patient-controlled analgesia, peripheral nerve blocks, intercostals, paravertebral and epidural blocks. Each of them with advantages and disadvantages, but without being able to demonstrate a clear superiority between them, both the paravertebral and epidural blocks are the ones that accumulate the most reports in the literature regarding the management of postoperative pain, but at the same time they are not exempt from complications such as technical failure, hypotension and difficulty of the procedure. In addition to documenting a low use of thoracic epidurals in VATS. At the end of 2016, the description of the Erector Spinal Block (ESP) by Forero was published, it blocks the ventral and dorsal branch of the unilateral thoracic roots. It corresponds to an interfacial block that produces an extensive multidermatomal sensitive block with a single puncture, covering the anterior, lateral and posterior aspect of the thorax. One of its main advantages would be safety, possible less nerve damage and pneumothorax, as well as the simplicity of execution of this block. What has positioned it as another analgesic alternative in this type of surgery. In ESP, the pharmacokinetic (PK) profile that local anesthetics would have when injected into this interfacial compartment has not yet been described, and what will be the real impact of the use of vasoconstrictor in terms of plasma levels and duration of the block. Considering the above, it is important to know the pharmacodynamics of levobupivacaine after performing an ESP block with ultrasonography in order to know the risks of toxicity from local anesthetics as well as to clinically characterize this block in patients who will undergo VATS. The first objective of this study is to compare the plasma levels of levobupivacaine achieved after performing an ESP Block with or without epinephrine. As secondary objectives, it is proposed to characterize the block in terms of duration, pain, opioid requirements in the first 24 hours and adverse events, in both groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthetics Complications, Anesthetic Toxicity, Bupivacaine Overdose, Nerve Block, Surgery
Keywords
ESP, Perioperative Care, Bupivacaine Overdose, VATS surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomized into two groups, this will be done through a table of computer-generated random numbers. Group I will receive ESP block with vasoconstrictor and Group II will receive ESP block without vasoconstrictor.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group I Epi
Arm Type
Experimental
Arm Description
The ESP will be performed under ultrasound vision at T5 level, with the patient seated. Once the ultrasound image is achieved, a 100 mm, 20 G Stimuplex needle will be punctured and a solution of levobupivacaine 0.25% with epinephrine 5 ug/ml completing a volume of 20 ml.
Arm Title
Group II no Epi
Arm Type
Active Comparator
Arm Description
The ESP will be performed under ultrasound vision at T5 level, with the patient seated. Once the ultrasound image is achieved, a 100 mm, 20 G Stimuplex needle will be punctured and a solution of levobupivacaine 0.25% without epinephrine completing a volume of 20 ml.
Intervention Type
Drug
Intervention Name(s)
Levobupivacaine 0.25% with epinephrine 5 ug/ml
Other Intervention Name(s)
ESP, Bupivacaine
Intervention Description
The block will be performed under ultrasound vision at T5 level, with the patient seated. Once the ultrasound image is achieved, a 100 mm, 20 G Stimuplex needle will be punctured and a solution of levobupivacaine 0.25% with epinephrine 5 ug / ml until completing a volume of 20 ml in fractional form.
Intervention Type
Drug
Intervention Name(s)
Levobupivacaine 0.25% without epinephrine 5 ug/ml
Other Intervention Name(s)
ESP, Bupivacaine
Intervention Description
The block will be performed under ultrasound vision at T5 level, with the patient seated. Once the ultrasound image is achieved, a 100 mm, 20 G Stimuplex needle will be punctured and a solution of levobupivacaine 0.25% without epinephrine 5 ug / ml until completing a volume of 20 ml in fractional form.
Primary Outcome Measure Information:
Title
Plasma levels of levobupivacaine
Description
Levobupivacaine plasma levels will be measured using High-performance liquid chromatography.
Time Frame
5, 10, 20, 30, 60, 90 minutes post block.
Title
Changes in plasma levels levobupivacaine of the group I v/s group II
Description
To assess the changes in plasma levels of the group I with epinephrine versus the group II without epinephrine.
Time Frame
5, 10, 20, 30, 60, 90 minutes post block.
Title
Sensitive skin extension
Description
Determine the sensitive skin extension of ESP after its performance using pinprick and temperature discrimination using an alcohol swab.
Time Frame
15 minutes post-block
Secondary Outcome Measure Information:
Title
Pain measured
Description
Pain measured by Verbal Numerical Scale (VNS) 0 to 10. 0 = no pain. 10 = worse pain.
Time Frame
Every 15 minutes per 2 hours in the PACU and 12 hrs, 24 hrs, 48 hrs during hospitalization
Title
Heart Rate
Description
Heart rate (bpm)
Time Frame
Every 5 min. Since entering operating room up to end of anesthesia and leaving to recovery room. In average 2 hrs.
Title
Hemodynamics
Description
Invasive arterial pressure (mmHg)
Time Frame
Every 5 min. Since entering operating room up to end of anesthesia and leaving to recovery room. In average 2 hrs.
Title
Pulse oximetry
Description
% oximetry saturation
Time Frame
Every 5 min. Since entering operating room up to end of anesthesia and leaving to recovery room. In average 2 hrs.
Title
Consumption of morphine or its equivalents
Description
Consumption of morphine or its equivalents (mg/kg/hr)
Time Frame
During the first 48 hours including intraoperative and postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Indication of VATS ASA I-II Body mass index (BMI) 20-34 kg / m2 Exclusion Criteria: Patients with conversion to thoracotomy History of chronic pain Drug abuse Psychiatric illness Allergic to some of the drugs used in the study Chronic analgesic users History of peripheral neuropathy Who refuse the procedure
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea Araneda, MD
Phone
223543270
Email
andreaaraneda10@yahoo.es
First Name & Middle Initial & Last Name or Official Title & Degree
Victor Contreras, MSN, RN
Phone
223549217
Email
vecontre@uc.cl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Araneda, MD
Organizational Affiliation
Clinician
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pontificia Universidad Catolica de Chile
City
Santiago
State/Province
Metropolitana
ZIP/Postal Code
450881
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victor Contreras, MSN, RN
Phone
223549217
Email
vecontre@uc.cl

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Procedure performance of ESP in terms of duration and user satisfaction
IPD Sharing Time Frame
After the paper publication
IPD Sharing Access Criteria
Researchers and clinicians related to the analgesic management of patients, upon formal request via e-mail to the research director.
Citations:
PubMed Identifier
23038415
Citation
Corvetto MA, Echevarria GC, De La Fuente N, Mosqueira L, Solari S, Altermatt FR. Comparison of plasma concentrations of levobupivacaine with and without epinephrine for transversus abdominis plane block. Reg Anesth Pain Med. 2012 Nov-Dec;37(6):633-7. doi: 10.1097/AAP.0b013e31826c330a.
Results Reference
background

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PK/PD Levobupivacaine With and Without Epinephrine After Ultrasound Guided ESP Block

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