A randomized controlled trial of an enhanced recovery after surgery protocol in patients undergoing laparoscopic sleeve gastrectomy

Abstract

Background

The purpose of this study was to evaluate the effect of an enhanced recovery after surgery (ERAS) protocol on opioid and anti-emetic use, length of stay and safety after laparoscopic sleeve gastrectomy (LSG).

Methods

Patients who underwent LSG between March 2018 and January 2019 at our accredited, high-volume bariatric surgery center were randomized to either standard of care (SOC) or ERAS. ERAS included a pre- and post-surgical medication regimen designed to reduce postoperative nausea, vomiting and pain. Outcomes included post-operative symptom scores, opioid use, anti-emetic use, time to achieve readiness for discharge (RFD) and inpatient and 30-day adverse events, readmissions and emergency department visits.

Results

The final analysis included 130 patients, (SOC 65; ERAS 65). Groups did not differ on demographics or comorbidities. Relative to SOC, fewer ERAS patients utilized opioids in the hospital ward (72.3% vs. 95.4%; p < .001), peak pain scores were significantly lower, and median time to achieve RFD was shorter (28.0 h vs. 44.4 h; p = 0.001). More ERAS patients were discharged on post-operative day 1 (38.5% vs. 15.4%; p < .05). The overall use of rescue anti-emetic medications was not different between groups. Rates of postoperative 30-day events, readmissions, and emergency department visits did not differ between groups.

Conclusion

Relative to SOC, ERAS was associated with earlier discharge, lower pain scores, less frequent use of opioids and use in lower amounts after LSG with no differences in 30 day safety outcomes.

Graphical abstract

Appendix

Pain numeric rating scale

The Pain Numeric Rating Scale (which asks patients to rate their pain on a 0–10 scale) equates to categories of mild, moderate and severe pain used for medication dosing orders. The nurse describes the scale to the patient. For patients who have trouble assigning a numeric value (or understanding what the numbers between 0 and 10 indicate), descriptions of each number in relation to functional ability are as follows:

0 = no pan.

2 = mild pain, does not limit activities.

4 = moderate pain, can do most activities with rest.

6 = unable to do some activities because of pain.

8 = severe pain, unable to do most activities because of pain.

10 = excruciating, unable to do any activities because of pain.

Post-operative nausea and vomiting (ponv) impact scale

• Q1. Have you vomited or had dry-retching*?

  • 0. No.

  • 1. Once.

  • 2. Twice.

  • 3. Three or more times.

• Q2. Have you experienced a feeling of nausea (“an unsettled feeling in the stomach and slight urge to vomit”)? If yes, has your feeling of nausea interfered with activities of daily living, such as being able to get out of bed, being able to move about freely in bed, being able to walk normally, or eating and drinking?

  • 0. Not at all.

  • 1. Sometimes.

  • 2. Often or most of the time.

  • 3. All of the time.

Post-operative nausea and vomiting (ponv) impact scale

To calculate the PONV Impact Scale score, add the numerical responses to questions 1 and 2. A PONV Impact Scale score of ≥ 5 defines clinically important PONV.

*count distinct episodes: several vomits or retching events occurring over a short time frame, say 5 min, should be counted as one vomiting/dry-retching episode; multiple episodes require distinct time periods without vomiting/dry-retching.

Readiness for discharge checklist components

• 1. Tolerate a minimum of 450 ml of bariatric liquid diet over a period of 8 h (rolling time) after starting the bariatric clear liquid diet.

• 2. Ambulate without assistance or same level of assistance as prior to surgery.

• 3. Attain pulse rate < 90 beats/min, temperature ≤ 37.6 °C, respiratory rate < 20 breaths/min.

• 4. Attain pain score of 6 or less (on the 0 to 10 scale).

• 5. Attain PONV score of 3 or less (on the 0–6 scale).

Statistical details

For categorical measures, we report the effect size as an odds ratio of the presence of the characteristic or outcome compared with its absence; for gender and ethnicity, the reference groups are male and Caucasian, respectively. For continuous variables, the effect size is typically calculated as difference in means divided by standard deviation but as distributions were not normal and non-parametric statistics were employed, the effect size reported is Cohen’s d, calculated from Cohen’s r which is recommended for Wilcoxon [22, 23] and based on the z statistic calculated for Wilcoxon. The 95% confidence interval was then calculated for Cohen’s d [24].