The effect of newly designed dual-channel elastomeric pump for intravenous patient-controlled analgesia after total laparoscopic hysterectomy: a randomized, double-blind, prospective study

Abstract

Background: A newly designed intravenous patient-controlled analgesia (PCA) device with a dual-channel elastomeric infusion pump has been recently introduced. One channel is a continuous line with a constant flow rate basal infusion, while the other channel has an adjustable flow rate and bolus function and is labeled as a selector-bolus channel. This study compared dual and single-channel intravenous PCA in terms of clinical effect and quality of recovery.

Methods: Eighty-four patients undergoing total laparoscopic hysterectomy were randomly allocated to a 1-channel group (n = 41) or a 2-channel group (n = 43). Only the selector-bolus channel was utilized, but the continuous channel was not utilized in the 1-channel group, but both channels were utilized in the 2-channel group. In the 1-channel group, 16 μg/kg of fentanyl, 2 mg/kg of ketorolac, and 12 mg of ondansetron with normal saline were administered to the selector-bolus channel and normal saline only in the continuous channel for blinding. In the 2-channel group, 16 μg/kg of fentanyl was administered to the selector-bolus channel, and ketorolac (2 mg/kg) and ondansetron (12 mg) were administered via the continuous channel. The quality of recovery was evaluated preoperatively and 24 h postoperatively using the Quality of Recovery-40 (QoR-40). Cumulative PCA consumption, postoperative pain rated using the numeric rating scale (NRS; during rest/cough), and postoperative nausea were evaluated 6, 12, 24, 36, and 48 h after surgery. Incidence of vomiting and use of antiemetics and rescue analgesics was measured.

Results: The 24-h postoperative QoR-40 score was higher in the 2-channel group than in the 1-channel group (P=0.031). The incidence of nausea at 12 h and 36 h was significantly higher in the 1-channel group (P=0.043 and 0.040, respectively), and antiemetic use was more frequent in the 1-channel group (P=0.049). Patient satisfaction was higher in the 2-channel group (P=0.036). No significant differences were observed in pain scores during resting/cough or cumulative PCA consumption.

Conclusions: The 2-channel PCA showed better patient satisfaction with higher QoR-40 during the recovery compared with the 1-channel PCA. Better satisfaction was associated with lower nausea and reduced rescue antiemetics by maintaining the infusion of adjuvant analgesic agents and antiemetic agents constantly by utilizing dual channels.

Trial registration: Registered at ClinicalTrials.gov , NCT04082039 on 9 September 2019.

Keywords: Hysterectomy; Patient satisfaction; Patient-controlled analgesia; Postoperative nausea and vomiting; Quality of recovery.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2022. The Author(s).

Figures

Fig. 1

Photograph of the Bellomic Duo® silicone balloon infuser

Fig. 2

Schematic of the PCA device and its application. A In the 1-channel group, only the selector-bolus channel was actually utilized. B In the 2-channel group, both the selector-bolus channel and continuous channel were utilized by dividing the drugs between the two. The adjustable flow dial has a range of 0, 1, and 2 mL/h, but only 0 or 2 mL/h were used in both groups per our study protocol

Fig. 3

A flowchart describing patient recruitment, randomization, and withdrawal

Fig. 4

Violin plots of the global QoR-40 at preoperative period and preoperative 24 h. The change in the QoR-40 score from the preoperative period to the postoperative 24 h in the 1-channel group was significantly decreased, but not in the 2-channel group (P < 0.001 and P = 0.819, respectively, by the Wilcoxon signed-rank test). Abbreviations: QoR-40, quality of recovery-40 questionnaire