Actively Recruiting
ESP Block Versus Wound Infiltration for Laminectomy: a Randomized Controlled Trial
Led by University of Padova · Updated on 2025-06-26
112
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of the Erector Spinae Plane Block (ESPB) compared to wound infiltration for managing pain in patients undergoing laminectomy surgery. This study focuses on improving perioperative pain control, which is often challenging in spinal surgery, as inadequate pain relief can delay recovery and increase complications. The ESPB targets nerves near the spine to provide localized pain relief and may enhance overall surgical outcomes. Participants are randomly assigned to one of two groups. One group receives an ESPB with a local anesthetic called ropivacaine before surgery, along with a saline wound infiltration. The other group receives an ESPB with saline and wound infiltration with ropivacaine. Both treatments are delivered using ultrasound guidance to ensure precise administration near the spine or surgical site. During the study, researchers will monitor participants' pain levels at various times after surgery, including immediately at extubation and at 6, 12, and 24 hours post-surgery. They will also track the amount of tramadol pain medication used during the first 24 hours after surgery, time to first additional pain medication, and side effects such as nausea, respiratory depression, itching, and motor block. Patient satisfaction and opioid use during surgery will be evaluated. The study participation lasts through the first 24 hours after surgery for these assessments.
CONDITIONS
Brief Title
ESP Block Versus Wound Infiltration for Laminectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Planned 1 or 2 level surgical laminectomy
- Age 18 years or older
You will not qualify if you...
- Allergy to local anesthetics
- Refusal of consent
- Uncompensated heart, kidney, liver disease or peripheral neuropathies
- Blood disorders that increase bleeding risk
- Gastrointestinal ulcers or bleeding
- Local infection at the surgical site
- Psychiatric or neurological disorders unrelated to the primary disease
- History of substance abuse or use within 24 hours before surgery
- Alcohol addiction
- ASA physical status classification greater than 3
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo surgery with either ESP block or wound infiltration of local anesthetic or saline for pain management.
1 visit (in-person)
Duration - 24 hours after surgery
Participants are observed for pain levels and side effects during the first 24 hours after surgery.
Approximately 1 visit (in-person)
Trial Site Locations
Total: 1 location
1
University Hospital of Padova
Padova, Veneto, Italy, 35127
Actively Recruiting
Research Team
A
Alessandro De Cassai
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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