Evaluation of the postoperative analgesic efficacy of erector spinae plane block in lumbar spinal surgery: a prospective randomized double-blind study

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-504204-28-00

Enrollment

126

Registered

2023-09-19

Start date

2023-10-17

Completion date

Unknown

Last updated

2024-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients undergoing lumbar arthrodesis

Brief summary

The primary objective will define wether or not ESPB is effective at reducing opioid consumption, in morphine oral equivalent, during the first 24 hours postoperatively

Detailed description

Analysis of intraoperative parameters (blood pressure, heart rate, Response and State Entropy (RE/SE), Surgical Plethysmographic Index (SPI) at the time of the block, during incision and at extubation., Absence of complications related to the block, Opioid use in the PACU, Level of drowsiness in PACU (RASS score), Pain scores at different time intervals from PACU to hospital discharge, Length of hospitalization, Assessment of the quality of postoperative recovery using the QoR-15 score at PCA withdrawal, Presence of PONV, constipation, pruritus

Interventions

DRUGEtoricoxib AB 60 mg comprimés pelliculés

DRUGMORPHINE HCl STEROP 10mg/1ml Solution injectable

DRUGParacetamol Fresenius Kabi 10 mg/ml oplossing voor infusie

DRUGRocuronium B. Braun 10 mg/ml oplossing voor injectie / infusie

DRUGLevobupivacaine Fresenius Kabi 5 mg/ml Injektionslösung / Infusionslösung

DRUGTRADONAL

DRUG100 mg

DRUGsolution injectable

DRUGSolu-Medrol S.A.B. (= Sine Alcohol Benzylicus) Act-O-Vial 125 mg Poudre et solvant pour solution injectable (méthylprednisolone)

DRUGPropolipid 1% emulsie voor injectie of infusie

DRUGChlorure de sodium 0

DRUG9% Fresenius Kabi solvant pour préparation parentérale

DRUGLinisol 1 %

DRUGoplossing voor injectie

DRUGSévoflurane Baxter 100 %

DRUGliquide pour inhalation par vapeur

DRUGSufentanil Mylan 5 Mikrogramm/ml Injektionslösung

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary objective will define wether or not ESPB is effective at reducing opioid consumption, in morphine oral equivalent, during the first 24 hours postoperatively	—

Secondary

Measure	Time frame
Analysis of intraoperative parameters (blood pressure, heart rate, Response and State Entropy (RE/SE), Surgical Plethysmographic Index (SPI) at the time of the block, during incision and at extubation., Absence of complications related to the block, Opioid use in the PACU, Level of drowsiness in PACU (RASS score), Pain scores at different time intervals from PACU to hospital discharge, Length of hospitalization, Assessment of the quality of postoperative recovery using the QoR-15 score at PCA withdrawal, Presence of PONV, constipation, pruritus	—

Measure

Time frame

—

Countries

Belgium

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026