Erector Spinae Plane (ESP) Block for Pain Management in Juvenile Idiopathic Scoliosis Surgery: a Single-center, Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this prospective controlled randomized clinical trial is to compare two intraoperative anesthetic patient management in Spinal surgery for idiopathic scoliosis. In particular in one Group of adolescent patients, the Erector Spinae (ESP) Block (an ultrasound-guided regional anesthesia technique) will be performed in addition to general anesthesia before surgical incision, while in the other Group the usual care (only General anesthesia, no Application of regional Block) will be applied. The fact that the ESP block acts on the dorsal branches of the spinal nerves, which innervate the paraspinal and vertebral muscles, makes this technique useful in the pain management of spine surgery. The main questions the study aims to answer are: 1. Verify if the pain measured in the two comparison groups in the first 24 postoperative hours is lower in the ESP Group. 2. Verify if the quantity of e.v opioid used intraoperatively, is lower in ESP Group 3. Verify if in ESP Group the Quantity of additional analgesics calculated by self-administered PCA doses of morphine (patient-controlled analgesia) in the first 24 hours postoperatively is lower than those administered in the usual care Group. 4. Verify if there are some differences between the two studied groups as regard the: Time to resume walking (expressed in hours from post-operative awakening); bowel movement recovery time (expressed in hours from post-operative awakening); Hospitalization time (expressed in days from the date of surgery until discharge).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 14
Maximum Age: 25
Healthy Volunteers: f
View:

• Elective indication for spine surgery for idiopathic scoliosis at the Spinal Surgery Department and Clinic 1 of the Rizzoli Orthopedic Institute.

• ASA Status 1 - 3

• BMI\<32

• Expression of assent to informed consent

Locations
Other Locations
Italy
Istituto Ortopedico Rizzoli
RECRUITING
Bologna
Time Frame
Start Date: 2023-09-11
Estimated Completion Date: 2027-12-30
Participants
Target number of participants: 400
Treatments
Active_comparator: (AG+ESP) Group
In AG+ ESP Group , the ESP block and the General anesthesia will be performed together in the same patient
Sham_comparator: AG Group
In AG Group the ESP block wont' be performed, but only a shamed block, realized through 4 skin puncture
Related Therapeutic Areas
Sponsors
Leads: Istituto Ortopedico Rizzoli

This content was sourced from clinicaltrials.gov

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