ESP Blocks for Postoperative Pain
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the effectiveness of a pain blocker, known as an erector spinae plane (ESP) block, in managing pain after back surgery. Participants will receive an ESP block with either regular bupivacaine (a local anesthetic) or bupivacaine mixed with a time-release version. The trial will assess the amount of pain medication needed, pain levels, hospital stay duration, and recovery time after surgery. It seeks English-speaking adults undergoing specific types of back surgery (cervical or lumbar posterior spinal fusion) who do not have chronic pain or opioid dependence. As a Phase 4 trial, this research aims to understand how the already FDA-approved treatment benefits a broader range of patients.
Do I need to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, if you are on anticoagulants (blood thinners) or have certain health conditions like chronic pain or opioid dependence, you may not be eligible to participate.
What is the safety track record for these treatments?
Research has shown that erector spinae plane (ESP) blocks are well-tolerated for pain relief after spinal surgery. Studies have found that bupivacaine, alone or with liposomal bupivacaine, effectively reduces pain and lessens the need for opioids post-surgery. For instance, a review of several studies found that ESP blocks lowered pain levels and reduced the need for pain medication.
Research also suggests that ESP blocks with liposomal bupivacaine are both effective and safe. These blocks have been tested in various surgeries and have managed pain well. Reports of serious side effects are few, making them a promising option for post-surgery pain management.
Overall, both types of bupivacaine used in ESP blocks have a good safety record. They help control pain and reduce the need for strong pain medications like opioids, which can have more side effects.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about ESP blocks with bupivacaine for postoperative pain because they offer a unique approach compared to standard pain management methods like opioid medications and other regional anesthesia techniques. The combination of bupivacaine with liposomal bupivacaine in one of the treatments provides prolonged pain relief, potentially reducing the need for opioids, which can have significant side effects. The other treatment option uses plain bupivacaine, providing a simpler alternative that still aims to effectively manage pain. These treatments focus on targeting the specific nerve pathways involved in pain, offering targeted relief with potentially fewer side effects.
What evidence suggests that ESP blocks are effective for postoperative pain?
Studies have shown that using ESP (erector spinae plane) blocks with bupivacaine effectively relieves pain after spine surgery. Research indicates that this method reduces the need for opioids and lowers pain levels. In this trial, one group will receive an ESP block with plain bupivacaine, while another group will receive an ESP block with both bupivacaine and liposomal bupivacaine. Adding liposomal bupivacaine, a long-lasting version, can extend pain relief up to 72 hours. This combination has decreased the need for extra pain medication. Overall, the ESP block with both types of bupivacaine shows promise for effectively managing post-surgery pain.34678
Who Is on the Research Team?
Stephen Davies
Principal Investigator
Duke University
Are You a Good Fit for This Trial?
This trial is for patients undergoing cervical or lumbar posterior spinal fusion who need pain management post-surgery. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and not have conditions that would interfere with the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ESP blocks with either 0.5% bupivacaine plus liposomal bupivacaine or 0.5% plain bupivacaine
Follow-up
Participants are monitored for safety and effectiveness after treatment, including opioid consumption, pain scores, and time to ambulation
What Are the Treatments Tested in This Trial?
Interventions
- ESP Block with Bupivacaine
- ESP Block with Bupivacaine + Liposomal Bupivacaine
Find a Clinic Near You
Who Is Running the Clinical Trial?
Duke University
Lead Sponsor