- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06096480
Effect of Spinae Erector Block (ESP) and Gabapentin on Recovery and Length of Stay in Adolescent Spinal Fusion Patients
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Buenos Aires
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Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina, 1199
- Hospital Italiano de Buenos Aires
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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)
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through study completion, an average of 6 weeks
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Musculoskeletal Diseases
- Spinal Diseases
- Bone Diseases
- Spinal Curvatures
- Scoliosis
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Anti-Anxiety Agents
- Anticonvulsants
- Antimanic Agents
- Gabapentin
Other Study ID Numbers
- 6841
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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