Effect of Spinae Erector Block (ESP) and Gabapentin on Recovery and Length of Stay in Adolescent Spinal Fusion Patients

October 21, 2023 updated by: DELFINA SANCHEZ NOVAS, Hospital Italiano de Buenos Aires

Effect of Bilateral Spinae Erector Block (ESP) and Perioperative Gabapentin on Recovery and Length of Stay in Adolescent Spinal Fusion Patients: A Retrospective Cohort Stud

A retrospective cohort study comparing time to ambulation (hours) between two groups of adolescent spinal fusion patients: a group who received intravenous multimodal analgesic strategy alone (MMA group) and another group who received a multimodal analgesic strategy in combination with a preoperative ESP block and oral gabapentin (MMA-ESP-G group).

Study Overview

Status

Active, not recruiting

Detailed Description

One of the major challenges in postoperative care following posterior spinal fusion (PSF) for adolescent idiopathic scoliosis (AIS) is achieving adequate pain control. Opioid-sparing multimodal anesthetic strategies are crucial for achieving effective postoperative pain control and facilitating early mobilization. The erector spinae (ESP) block has been reported as part of various opioid-sparing strategies for spine surgery. Perioperative oral gabapentin (in different dosing protocols) may contribute to reduce postoperative pain and opioid consumption.

The primary aim of this retrospective study was to compare time to ambulation (hours) between two groups of adolescent spinal fusion patients: a group who received intravenous multimodal analgesic strategy alone (MMA group) and another group who received a multimodal analgesic strategy in combination with a preoperative ESP block and oral gabapentin (MMA-ESP-G group). The secondary aim was to compare intensive care length of stay, perioperative opioid requirements and time to urinary catheter removal between groups.

This is a retrospective review of 34 consecutive adolescent spinal fusion patients during August-September 2023 at Hospital Italiano de Buenos Aires, Argentina. The investigators compared two groups: 1) MMA group received an intravenous multimodal analgesic strategy, 2) MMA-ESP-G group received an intravenous multimodal analgesic strategy in combination with a preoperative, ultrasound-guided, bilateral ESP block (administration of a local anesthetic mixture of ropivacaine 0.375% and lidocaine 1%) and a 100mg dose of oral gabapentin 4 nights daily before surgery and 2 weeks postoperatively. Both strategies were protocolized at our institution.

Data was analyzed for the primary outcome: median time to ambulation difference between groups. Differences were considered statistically significant at p < 0.05.

Study Type

Observational

Enrollment (Actual)

34

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Buenos Aires
      • Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina, 1199
        • Hospital Italiano de Buenos Aires

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

adolescent spinal fusion patients from Hospital Italiano de Buenos Aires

Description

Inclusion Criteria:

  • Patients with a diagnosis of adolescent idiopathic scoliosis (AIS) and primary surgical indication between January 2018 and August 2023.
  • ASA patients (American Society of Anesthesiology classification) I to III.

Exclusion criteria:

  • Patients who, at the end of the procedure, were transferred to the PICU (Pediatric Intensive Care Unit) on mechanical ventilation.
  • Patients undergoing corrective scoliosis surgery in combination with any other surgical procedure.
  • Patients who received ESP block postoperatively (Group EM-ESP-G).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MMA group
adolescent spinal fusion patients who received intravenous multimodal analgesic strategy alone
MMA-ESP-G group
adolescent spinal fusion patients who received a multimodal analgesic strategy in combination with a preoperative ESP block and oral gabapentin
preoperative, ultrasound-guided, bilateral ESP block (administration of a local anesthetic mixture of ropivacaine 0.375% and lidocaine 1%) and a 100mg dose of oral gabapentin 4 nights daily before surgery and 2 weeks postoperatively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time to ambulation
Time Frame: through study completion, an average of 6 weeks
time to ambulation (hours)
through study completion, an average of 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2023

Primary Completion (Actual)

September 30, 2023

Study Completion (Estimated)

October 12, 2023

Study Registration Dates

First Submitted

October 15, 2023

First Submitted That Met QC Criteria

October 21, 2023

First Posted (Actual)

October 23, 2023

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 21, 2023

Last Verified

October 1, 2023

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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