A Randomized Controlled Trial of Postoperative Thoracic Epidural Analgesia Versus Intravenous Patient-controlled Analgesia After Major Hepatopancreatobiliary Surgery

Abstract

Objectives: The primary objective of this randomized trial was to compare thoracic epidural analgesia (TEA) to intravenous patient-controlled analgesia (IV-PCA) for pain control over the first 48 hours after hepatopancreatobiliary (HPB) surgery. Secondary endpoints were patient-reported outcomes, total narcotic utilization, and complications.

Background: Although adequate postoperative pain control is critical to patient and surgeon success, the optimal analgesia regimen in HPB surgery remains controversial.

Methods: Using a 2.5:1 randomization strategy, 140 patients were randomized to TEA (N = 106) or intravenous patient-controlled analgesia (N = 34). Patient-reported pain was measured on a Likert scale (0-10) at standard time intervals. Cumulative pain area under the curve was determined using the trapezoidal method.

Results: Between the study groups key demographic, comorbidity, clinical, and operative variables were equivalently distributed. The median area under the curve of the postoperative time 0- to 48-hour pain scores was lower in the TEA group (78.6 vs 105.2 pain-hours, P = 0.032) with a 35% reduction in patients experiencing ≥7/10 pain (43% vs 62%, P = 0.07). Patient-reported outcomes and total opiate use further supported the benefit of TEA on patient experience. Anesthesia-related events requiring change in analgesic therapy were comparable (12.2% vs 2.9%, respectively, P = 0.187). Grade 3 or higher surgical complications (6.6% vs 9.4%), median length of stay (6 days vs 6 days), readmission (1.9% vs 3.1%), and return to the operating room (0.9% vs 3.1%) were similar (all P > 0.05). There were no mortalities in either group.

Conclusions: In major HPB surgery, TEA provides a superior patient experience through improved pain control and less narcotic use, without increased length of stay or complications.

Trial registration: ClinicalTrials.gov NCT01438476.

Figure 1

Consort Flow Diagram

Figure 2

Pain Scores Over Time in Thoracic Epidural Analgesia (TEA) vs. Intravenous Patient Controlled Analgesia (IV-PCA). The depicted 95% confidence bands represent interval estimators that characterize the extent of uncertainty for mean estimation of pain score at significance level 0.05 over the 48-hour follow-up time.

Figure 3

Median Oral Morphine Equivalent (with Interquartile Range) Used on Each Postoperative Day in Thoracic Epidural Analgesia (TEA) vs. Intravenous Patient Controlled Analgesia (IV-PCA)

Figure 4

Patient Satisfaction with Thoracic Epidural Analgesia (TEA) vs. Intravenous Patient Controlled Analgesia (IV-PCA) measured by the Health Outcomes Recovery Survey (HORS): Lower score indicates better patient reported pain satisfaction.