TY  - JOUR
AU  - Takeo Mammoto
AU  - Noriko Taguchi
AU  - Shunji Takei
AU  - Yoshiyuki Imoo
AU  - Enbo Ma
PY  - 2022
DA  - 2022/08/25
TI  - Effects of zolpidem administration on postoperative pain in patients after total knee arthroplasty: Study protocol for a randomized controlled trial
JO  - Archives of Clinical Trials
VL  - 2
IS  - 2
AB  - Background: Postoperative patients commonly have sleep disturbances. Sleep quality is associated
with pain intensity. Thus, a vicious cycle of poor sleep quality that increases pain and disrupts sleep
quality occurs. However, little is known about the impact of postoperative sleep management on
postoperative pain and functional recovery after total knee arthroplasty (TKA). Here, we designed a
randomized controlled trial to investigate the effects of zolpidem on postoperative pain control and
functional recovery after TKA. We hypothesized that zolpidem would decrease postoperative pain and
simultaneously improve knee ROM and sleep quality.
Methods: This randomized, prospective, controlled trial will include 88 patients scheduled to undergo
unilateral TKA. Patients will be randomized to one of the two groups, one of which will receive zolpidem
postoperatively. The primary endpoint will be the visual analogue scale (VAS) pain score on postoperative
day 2. Secondary outcomes are sleep quality (nocturnal arousal, frequency of body movements, and
sleep effects), knee joint range of motion, opioid consumption, incidence of postoperative nausea and
vomiting (PONV), and rescue analgesic consumption. Protocols were developed in accordance with the
SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) guidelines.
Discussion: Sleep quality significantly affects pain intensity. Therefore, it is hypothesized that
postoperative administration of hypnotics to improve sleep quality may reduce pain intensity. In this
study, we hypothesized that zolpidem administration will decrease postoperative pain, which will
simultaneously improve knee joint ROM and sleep quality. This randomized, controlled trial will
provide insight into optimizing perioperative sleep management strategies by evaluating the effects of
postoperative hypnotic administration in patients post-TKA. These results of the study may improve
clinical practice in terms of perioperative sleep management and enhance patient recovery and
satisfaction.
Name of the registry: Effects of Sleep Management on Postoperative Pain in patients after total knee
arthroplasty. A randomized controlled study.
Trial Registration: UMIN000039116
Date of registration: 2020/Jan/15
URL of trial registry: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044407
SN  - 2768-4598
UR  - https://dx.doi.org/10.33425/2768-4598.1020
DO  - 10.33425/2768-4598.1020