A Phase 4 interventional study of Levobupivacaine 0.25% with epinephrine 5 ug/ml and Levobupivacaine 0.25% without epinephrine 5 ug/ml in Anesthetics Complications, Anesthetic Toxicity and Bupivacaine Overdose, sponsored by Pontificia Universidad Catolica de Chile. Completed at 1 site in Chile. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-03-12.
Sponsored by Pontificia Universidad Catolica de Chile · Phase 4, Interventional, and Treatment
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.
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.
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This study's enrollment of 38 is below the median of 100 across 98 interventional studies indexed under Drug Overdose.
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Exclusion Criteria:
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.
Drug: Levobupivacaine 0.25% with epinephrine 5 ug/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.
Drug: Levobupivacaine 0.25% without epinephrine 5 ug/ml
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.
Also known as: ESP, Bupivacaine
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.
Also known as: ESP, Bupivacaine
Plasma levels of levobupivacaine
Levobupivacaine plasma levels will be measured using High-performance liquid chromatography.
Time frame: 5, 10, 20, 30, 60, 90 minutes post block.
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.
Time frame: 5, 10, 20, 30, 60, 90 minutes post block.
Sensitive skin extension
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
Pain measured
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
Heart Rate
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.
Hemodynamics
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.
Pulse oximetry
% 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.
Consumption of morphine or its equivalents
Consumption of morphine or its equivalents (mg/kg/hr)
Time frame: During the first 48 hours including intraoperative and postoperative
Plan to share: Yes — Procedure performance of ESP in terms of duration and user satisfaction
Supporting information: Study protocol
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Pontificia Universidad Catolica de Chile