Phase 4
Completed N=240
Intermittent Bolus vs Continuous Infusion Via ESP Catheters RCT
Post Operative Pain
Source: ClinicalTrials.gov NCT05642416 ↗
Enrolled (actual)
240
Serious AEs
0.0%
Results posted
May 2026
Primary outcomePrimary: Opioid Consumption POD 1 — 86.6; 90.5 MME
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this prospective randomized controlled trial is to compare the effectiveness of two different delivery methods for postoperative pain management following cardiac surgery requiring median sternotomy: intermittent programmed LA bolus versus continuous LA infusion through ESP catheters. Effectiveness of analgesia will be assessed based on the subjects' NRS pain scores and opioid consumption. The primary outcome measure will be the patients' opioid consumption over the course of the 72 hours following surgery. Secondary outcomes measures that will be evaluated include NRS pain scores, intensive care unit (ICU) length of stay, and time to first dose of antiemetic in the postoperative period. It is hypothesized that the use of intermittent programmed LA boluses will provide better analgesia compared to continuous LA infusion through ESP catheters. The findings of this study will provide guidance regarding the optimal method of delivery for postoperative pain management in patients following cardiac surgery.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Opioid Consumption POD 1 |
86.6; 90.5 | — |
| PRIMARY Opioid Consumption POD 2 |
40.0; 43.0 | — |
| PRIMARY Opioid Consumption POD 3 |
18.8; 24.3 | — |
| SECONDARY NRS Pain Score POD 1 |
5.8; 5.79 | — |
| SECONDARY NRS Pain Score POD 2 |
5.8; 4.55 | — |
| SECONDARY NRS Pain Score POD 3 |
2.9; 3.36 | — |
| SECONDARY ICU Length of Stay |
5.6; 5.6 | — |
| SECONDARY Quality of Recovery 15 (QoR-15) Score POD 1 |
87; 84 | — |
| SECONDARY Quality of Recovery 15 (QoR-15) Score POD 2 |
96; 95 | — |
| SECONDARY Quality of Recovery 15 (QoR-15) Score POD 3 |
102; 100 | — |
| SECONDARY Time to First Antiemetic |
127; 134 | — |
| SECONDARY Time to First Bowel Movement |
29; 35 | — |
Eligibility Criteria
Inclusion Criteria
- Non-emergent elective cardiac surgery requiring median sternotomy for surgical exposure (i.e. CABG, aortic/mitral/tricuspid valve replacements) receiving ESP catheter preoperatively
- Age 18-90
Exclusion Criteria
- Placement and/or existence of cardiac assist devices (LVAD, RVAD, Balloon Pump, Impella)
- Neurocognitive dysfunction
- Patients who expire before extubation
- Non-English speaking
- Daily opioid therapy prior to surgery
- History of substance abuse
- BMI > 45
Data sourced from ClinicalTrials.gov (NCT05642416). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.