Title:
Post laparotomy pain management: A comparison between patient controlled analgesia pump, continuous subcutaneous
markane infusion, and bupivacaine liposomal injectable suspension.
Learning Objectives:
To compare post-laparotomy pain management between patient-controlled analgesia pump, continuous subcutaneous
bupivacaine infusion, and bupivacaine liposomal injectable solution.
Author:
Harish Yalamanchili, M.D.
Additional Authors:
Stephanie Buchanan, M.D., Jantzen Thorns, M.D., Nick McKenzie, M.D., Alisha Reiss, M.D., Victor Dizon, M.D., Phillip
Price, M.D.
Background:
Pain after laparotomy can be severely debilitating and can lead to longer average length of stays, increased overall costs and
decreased patient satisfaction scores. The traditional post-operative pain regimen has centered around opioid administration
but a number of adverse events such as respiratory depression, nausea, vomiting and constipation limit overall efficacy. A
multitude of clinical studies have demonstrated the efficacy of single dose liposome bupivacaine (EXPAREL; Pacira
Pharmaceuticals, Inc Parsippany, NJ, USA) in wound infiltration to improve post-operative pain control. No study has
compared liposome bupivacaine in a randomized prospective trial in post laparotomy patients.
Methods:
This is a prospective single center randomized clinical trial to compare post-operative pain management of patientcontrolled analgesic (PCA) pump alone, versus PCA with subcutaneous bupivacaine infusion (On-Q; I-Flow LLC/Kimberly
Clark, Roswell, GA) versus PCA with liposome bupivacaine injectable suspension in patients undergoing a laparotomy at a
community hospital. Randomization was used via note cards with a color assigned to each group and one of the cards
randomly drawn by a nurse not involved in the study. Over a period of 16 months, adult non-pregnant patients undergoing
laparotomies who were not on chronic pain medications ( ≥7 days) were included. Variables measured included age, sex,
ASA class, day of return of bowel function, total amount of narcotics used over 72 hours (including any breakthrough
medication), the average pain scores (on a numeric rating scale of 0-10, with 0 being no pain and 10 being the most severe )
as assessed by the nursing staff approximately every 8 hours for each time point (24, 48, and 72 hours) . Complications
tracked included death, nausea/vomiting, itching, infection, urinary retention, tachycardia and drowsiness. Analyses of
Variance (ANOVA) was used to compare groups for continuous measures. ANOVA with p-values <0.05 were followed up
with Tukey's pairwise comparison with an overall alpha of 0.05. Chi-square tests were used to compare groups for
categorical measures.
Results:
Thus far a total of 72 eligible patients are enrolled in the study , with 23 in group 1 (PCA only), 26 in group 2 (PCA + On-Q)
and 23 in group 3 (PCA + Exparel). There were no significant differences among the groups in regards to age (P = 0.257),
sex (P = 0.622), ASA class (P = 0.119), and day of return of bowel function (P = 0.698). Total amount of narcotic used over
72 hours was significantly different in the groups (p=0.015). The mean milligram narcotic use for group 1 , group 2 and
group 3 was 27.28 mg (st.dev=15.10), 23.55 (st.dev.=14.58) and 15.34(st.dev.=11.47), respectively. Using the Tukey
method, we noted no difference between groups 1 and 2 and groups 2 and 3, but significant difference between groups 1 and
3. Significant differences in pain scores on day 1 were found between the groups (p=0.015). Using the Tukey method, pain
score on day 1 was significantly higher in group 1 versus groups 2 or 3 (6.8 vs. 5.4 vs. 5.2). Pain scores were not significantly
different between the groups on days 2 and 3 (P = 0.084 and P = 0.247).There were no deaths among the 72 patients. The
percent of patients with one or more of the tracked complication for group 1, group2 and group 3 were 69.6 , 53.9 and 30.4,
respectively The percents were significantly higher in group 1 compared to group 3 (P = 0.007), but were not different
between groups 1 and 2 (P = 0.260) or 2 and 3 (P = 0.098).
Conclusion:
Exparel along with PCA has significantly improved patient's pain scores on post-op day 1, significantly decreased the total
narcotic use in a 72 hour post-op period, and significantly decreased complications when compared to PC A alone. Although
these differences did not reach statistical significance when comparing Exparel + PCA to On-Q + PCA, there was a definite
trend in decreased 72 hour narcotic use and post-op complications for the Exparel + PCA group.