Health TrialsbyHealthPanel

ESP Blocks for Posterior Spinal Fusion

ConditionPostoperative Pain
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorDuke University

About this trial

This prospective randomized double-blind study evaluates the efficacy of erector spinae plane (ESP) blocks on postoperative pain in patients undergoing cervical or lumbar posterior spinal fusion. Patients will receive either 0.5% bupivacaine plus liposomal bupivacaine or 0.5% plain bupivacaine. Outcomes include opioid consumption over 72 hours, pain scores, length of stay, and time to ambulation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

English speaking

Age 18-75

ASA physical status 1-3

Undergoing elective cervical or lumbar posterior spinal fusion (≤3 levels)

Disqualifiers

Age <18 or >75

ASA IV or V

Non-English speaking

BMI >40

Trial design

Design model

Parallel

Treatments tested in this trial

  • ESP Block with Bupivacaine

    Drug

    Cervical and lumbar ESP blocks performed under ultrasound guidance using plain bupivacaine.

  • ESP Block with Bupivacaine + Liposomal Bupivacaine

    Drug

    Cervical and lumbar ESP blocks performed under ultrasound guidance using bupivacaine admixed with liposomal bupivacaine.

Treatment groups

75 Participants
are divided into 2 treatment groups
Group A: ESP + Liposomal BupivacaineExperimental treatment 1 intervention
Group B: ESP + Plain BupivacaineExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Postoperative Pain as measured by opiate consumption

Morphine MilliEquivalents

Time frame
72 hours

Secondary outcomes

1

Postoperative Pain at rest and with movement as measured by patient reported pain scores

Numeric Rating Scale (0-10) 0 being no pain, 10 being worst pain imaginable

Time frame
4, 8, 12, 24, 48, and 72 hours
2

Discharge Readiness

Hospital and PACU Length of Stay

Time frame
72 hours
3

Postoperative Pain Severity as measured by required time for patient controlled-analgesia

Duration of patient controlled analgesia use

Time frame
72 hours
4

Incidents of post-operative nausea and vomiting

Post-operative Nausea and Vomiting

Time frame
72 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Duke University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: