A RANDOMIZED TRIAL COMPARING SURGICAL SITE INFILTRATION WITH LIPOSOMAL BUPIVACAINE TO THORACIC EPIDURAL FOR PATIENTS UNDERGOING LAPAROTOMY IN A GYNECOLOGIC ONCOLOGY SERVICE

Problem Statement:

Thoracic epidural analgesia (TEA) has been a key part of opioid-sparing multimodal perioperative analgesia with a failure rates as high as 30% and many patients will require supplemental opiates. Recently, Extended-release liposomal bupivacaine (LB) was approved by the FDA for surgical site infiltration to produce postsurgical analgesia. To date, there has never been a comparison between the analgesic efficacy of TEA and LB surgical site infiltration following open abdominal surgery.

Methods:

Patients (n=40) with gynecologic cancer and planned for laparotomy were randomized 1:1 to TEA or surgical site infiltration with LB. Participants rated their postoperative pain intensity on a scale of 0 to 10 every 6 hours and immediately before opioid medication. Coprimary endpoints were mean area under the curve (AUC) of visual analog scale (VAS) pain intensity scores and total opioid consumption from 0 to 48 hours postoperatively. The mean AUC of VAS pain intensity scores incorporates opioid consumption. Quality of recovery was assayed daily using the quality of recovery-15 survey instrument. Two sample t-tests and Wilcoxon rank-sum tests were used to compare the arms.

Results:

Mean age and BMI were 56 ±14 years and 30.6 ±13.6 kg/m2. The majority had invasive cancer (81%). Participants reported race as White (72.2%), Black (19.4%) and Asian (5.6%). Mean estimated blood loss was 659±987 mL and mean duration of surgery was 6.7±2.0 hours. Median length of stay was 4 days and did not differ between the two arms. Mean pain intensity scores were similar for TEA and LB (mean 3.7 vs 3.9), but total opioid consumption was lower in the LB arm compared to TEA (mean IV MME 34.1 vs 48.2). QOR-15 scores on postoperative day 1 and on day of discharge did not differ between the arms. The incidence of hypotension was similar between the arms; grade 1-2 and grade 3-4 hypotension were observed with EA in 31.3% and 12.5% of cases and in 25% and 10% of patients who received LB.

Conclusion:

Interim efficacy data suggest that surgical site infiltration with LB may be a valuable alternative to TEA for gynecologic oncology patients undergoing laparotomy on ERAS protocols.