Status:
COMPLETED
Erector Spinae Plane Block as Pain Management After Lumbar Fusion Surgery
Lead Sponsor:
Ilse van de Wijgert
Collaborating Sponsors:
Radboud University Medical Center
Conditions:
Spondylolisthesis
Lumbar Disc Herniation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Rationale: Lumbar spine surgery is associated with high postoperative pain scores and analgesic use, despite use of multimodal analgesia. The erector spinae plane block (ESPB) is a promising locoregio...
Detailed Description
Rationale: Lumbar spine surgery is associated with high postoperative pain scores and analgesic use. Despite multimodal pain treatment, time to first rescue treatment with opioids is often short and n...
Eligibility Criteria
Inclusion
- Age ≥ 18 years;
- Patients planned for elective lumbar spinal fusion surgery with a dorsal surgical approach;
- 1-4 fusion level spine surgery;
- Written informed consent.
Exclusion
- A Body Mass Index (BMI) \> 40 kg/m²;
- ASA physical health classification \> 3;
- Patients who will undergo spine surgery involving less than 2 or more than 4 levels of fusion, scoliosis surgery\*;
- Patients who will undergo circumferent spine surgery;
- Patients with an active, local infection or systemic infection;
- Patients with an allergy to one or more medications used in the study;
- Patients with any contraindication to a regional anesthetic technique;
- Kidney- or liver failure inhibiting the systemic use of paracetamol and/or NSAIDs;
- Acute surgeries;
- Patients with a history of drugs or alcohol abuse;
- Pregnancy;
- Cognitive impairment;
- Inability to speak or understand the Dutch language.
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 19 2024
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT05345249
Start Date
June 1 2022
End Date
January 19 2024
Last Update
April 17 2024
Active Locations (1)
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1
Sint Maartenskliniek
Ubbergen, Gelderland, Netherlands, 6500GM