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

Sponsor

Hospital Italiano de Buenos Aires (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT06096480

Collaborator

(none)

Enrollment

Location

2.4

Anticipated Duration (Months)

14.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Adolescent Idiopathic Scoliosis	Procedure: gabapentin + bilateral spine erector block

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 Design

Study Type:

Observational

Actual Enrollment :

34 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Aug 1, 2023

Actual Primary Completion Date :

Sep 30, 2023

Anticipated Study Completion Date :

Oct 12, 2023

Arms and Interventions

Arm	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	Procedure: gabapentin + bilateral spine erector block 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.

Arm

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

Procedure: gabapentin + bilateral spine erector block

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.

Outcome Measures

Primary Outcome Measures

time to ambulation [through study completion, an average of 6 weeks]
time to ambulation (hours)

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Italiano de Buenos Aires	Ciudad Autonoma de Buenos Aire	Buenos Aires	Argentina	1199

Sponsors and Collaborators

Hospital Italiano de Buenos Aires

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

DELFINA SANCHEZ NOVAS, Anesthesiologist, Hospital Italiano de Buenos Aires

ClinicalTrials.gov Identifier:

NCT06096480

Other Study ID Numbers:

6841

First Posted:

Oct 23, 2023

Last Update Posted:

Oct 23, 2023

Last Verified:

Oct 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Scoliosis

Gabapentin

Study Results

No Results Posted as of Oct 23, 2023