Erector Spinae Plane Block (ESP) Versus Thoracic Epidural Anesthesia in Video-Assisted Thoracoscopic Surgery (VATS) in Pediatric Population; a Randomized, Controlled Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-31

Study Completion Date

2023-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Aim of the study is to investigate the efficacy and safety of continuous ESP block in children under the age of 10 yrs undergoing video-assisted thoracoscopic procedures, compared to Thoracic Epidural Anesthesia (TEA).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Continuous Erector Spinae Block Versus Continuous Paravertebral Block

NCT03768440

Pain, Postoperative

TERMINATED PHASE3

Erector Spinae Plane Block for Post-thoracotomy Pain

NCT04013815

Pain, Postoperative

COMPLETED NA

Erector Spinae Plane Block for Peroperative Analgesia and Intraabdominal Tissue Oxygenation

NCT03808129

Lower Abdominal Surgery

COMPLETED NA

ESP Block in VATS: Programmed Intermittent Bolus Versus Continuous Infusion on Quality of Recovery

NCT05181371

Pain, Acute Surgery

COMPLETED NA

Erector Spinae Plane vs. Paravertebral Nerve Block for Thoracic Surgery

NCT03758261

Thoracic Surgical Procedures

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Primary outcome:

Post-operative pain assessed by FLACC (Face, Legs, Activity: Cry, Consolability) for children age 1-5 years, and NRS (numerical rating scale) for children age 6-10 years

Secondary outcomes:

* Opioid consumption for 48 hours post-operatively.
* Intraoperative opiod use
* Block failure rate (defined as Heart Rate (HR) increase of more than 20% of baseline at surgical incision)
* Time to extubation after surgery completion After parental consent, children aged 0-10 yrs scheduled for unilateral VATS procedure will be randomized into two groups: Thoracic Epidural Group (TEA) vs Erector Spinae Plane block (ESP).

Children with history of allergy to local anesthetics, systemic coagulopathy, infection at site of puncture, severe renal or liver disease, known rib cage malformations will be excluded from the study.

Anesthesia will be induced at operator's preference; before surgery beginning children will be positioned and either TEA or ESP will be performed. In both cases, a bolus of of 0.3-0.5ml/kg of 0.2% ropivacaine will be administered, followed by an infusion of 0.2mg/kg/hr for the next 48 hours. The time from block placement to incision will be recorded, change in HR before and after incision will be documented, need for intraoperative opiod use, time to first rescue analgesic, and total amount of local anesthetic given at 24 h and 48 h post-operatively will be recorded together with pain measures as specified. Opiods will be prescribed if child presents with FLACC scores \> 3 (FLACC score of 0-3 = mild pain, 4-6 = moderate, 7-10 = severe), or VAS \>5.

Total opioid consumption will be recorded.

Statistical analysis

Intention to treat analysis will be performed. Quantitative variables will be described as mean and standard deviation (sd) or median and interquartile range (IQR) if not normally distributed (Shapiro-Wilks test) For primary outcome, VAS or FLACC score will be compared with t-test or Mann-Whitney test Opioid consumption will be compared with t-test or Mann-Whitney test Block failure rate will be compared with chi2 test Time to extubation will be compared with log rank test

Sample size With 37 patients for group a power of 80% will be achieved to identify as significant a difference in mean pain score when sd is 1,5 times greater than mean. Alpha error will be 0.05 and a two-sample t-test will be applied.

Randomization A random block centralized randomization list will be generated before study start with Ralloc command in Stata. It will be stratified by center. To avoid allocation concealment the closed envelope method will be used.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain, Postoperative

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Erector Spinae plane Block

After induction of general anesthesia, patients will be positioned in lateral decubitus with surgical site up and the transverse process of T5-T7 vertebrae and Erector Spinae (ES) fascia will be located with a linear ultrasound probe. A 19G or 20G epidural needle (according to age) will be positioned under the ES muscle and a bolus of of 0.3-0.5ml/kg of 0.2% ropivacaine will be administered; after hydrodissection, the catheter will be threaded, followed by an infusion of 0.2mg/kg/hr for the next 48 hours.

Group Type EXPERIMENTAL

Erector Spinae Plane Block

Intervention Type OTHER

The ESP is fascial plane block performed by injecting local anesthetic between the erector spinae muscle and the transverse process. Its proposed mechanism of action is via blockade of the dorsal and ventral rami of the thoracic spinal nerves and sympathetic fibers.

Thoracic Epidural Anesthesia

After induction of general anesthesia, patients will be positioned in lateral decubitus with surgical site up and a 19G or 20G epidural needle (according to age) will be positioned at T5-T7 level with cathether placement; a bolus of of 0.3-0.5ml/kg of 0.2% ropivacaine will be administered and followed by an infusion of 0.2mg/kg/hr for the next 48 hours.

Group Type ACTIVE_COMPARATOR

Erector Spinae Plane Block

Intervention Type OTHER

The ESP is fascial plane block performed by injecting local anesthetic between the erector spinae muscle and the transverse process. Its proposed mechanism of action is via blockade of the dorsal and ventral rami of the thoracic spinal nerves and sympathetic fibers.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Erector Spinae Plane Block

The ESP is fascial plane block performed by injecting local anesthetic between the erector spinae muscle and the transverse process. Its proposed mechanism of action is via blockade of the dorsal and ventral rami of the thoracic spinal nerves and sympathetic fibers.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* ASA I-III
* Scheduled for Video-Assisted Thoracoscopic Procedure
* Parental consent

Exclusion Criteria

* Parental refusal
* History of allergy to local anesthetics
* Systemic coagulopathy
* Local infection at puncture site
* Severe renal or liver disease
* Known rib cage malformations

Minimum Eligible Age

1 Month

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No