Decreased opioid consumption and enhance recovery with the addition of IV Acetaminophen in colorectal patients: a prospective, multi-institutional, randomized, double-blinded, placebo-controlled study (DOCIVA study)

Abstract

Background

We hypothesized that administration of IV acetaminophen alone would reduce the opioid consumption in post-operative colorectal surgery and reduce the side effects of narcotics.

Methods

Patients were randomized to receive either IV acetaminophen or placebo in addition to opioid PCA. Primary endpoints evaluated were opioid consumption and pain visual analogue scale score (PVASS) during first 48 h post-operatively. Secondary endpoints evaluated were time of return of GI function (ROGIF), time to diet ordered (TTDO), length of hospital stay (LOHS), and occurrence of ileus.

Results

105 patients were enrolled and 97 remained in the study after exclusion (control group n = 50; study group n = 47). Mean ± SEs of opioid consumption in the study group was 21.5 ± 1.8 mg of morphine equivalent (ME) and 35.0 ± 3.3 mg ME at 24 and 48 h, respectively, versus 36.4 ± 4.1 mg ME and 59.7 ± 6.7 mg ME in the control group (p = 0.002 and 0.002). PVASS levels were lower in the study group at all intervals at 3, 8, 24, and 48 h (p = 0.02, 0.006, < 0.01, and 0.02). ROGIF, TTDO, and LOHS were also found to be lower in the study group (p ≤ 0.01, < 0.01, and 0.002). The rate of ileus was reduced by using IV acetaminophen (22% vs 2.1%; p = 0.004).

Conclusions

IV acetaminophen helps to reduce opioid consumption for patients undergoing colorectal surgery. Additionally, there appears to be a shortened length of hospital stay, better pain control, reduced time to return of bowel function, and lower rate of post-operative ileus in patients receiving IV acetaminophen.

Appendix A

Inclusion criteria

• Patient undergoing colorectal operation (Hartmann’s procedure, sigmoidectomy, left hemicolectomy, right hemicolectomy, transverse colectomy, ileocecectomy, colo-colonic anastomosis, colorectal anastomosis, ileocolonic anastomosis, low anterior resection, or abdominoperineal resection)

• Age range from 18 to 89 years old

• Patient demonstrating that they understood the information on the consent form and providing signed, written informed consent before participation in the study.

Exclusion criteria

• Patient younger than 18 years old or older than 89 years old

• Patient or family unable to give consent

• Patients who use opioids or tramadol daily for > 7 days before study medication administration (patient who, in the investigator’s opinion, had or was developing opioid tolerance)

• Patients who had a chronic pain condition or any significant medical disease, laboratory abnormality, or condition that, in the investigator’s judgment, could have compromised the subject’s welfare, ability to communicate with the study staff, complete study activities, or otherwise restricted study participation

• Patient who had hypersensitivity to opioids, acetaminophen, or the inactive ingredients of the study medication

• Patients who had known or suspected history of alcohol or drug abuse or dependence within the previous 1 year

• Patients who had impaired liver function

• Patients who had fever within first 48 h post-operatively and required acetaminophen for fever reduction.