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. 2021 Nov 16:14:3573-3581.
doi: 10.2147/JPR.S336870. eCollection 2021.

Deep Neuromuscular Blockade Combined with Low Pneumoperitoneum Pressure for Nociceptive Recovery After Major Laparoscopic Gastrointestinal Surgery: Study Protocol for a Randomized Controlled Trial

Yu-Qin Long  1   2 , Xi-Sheng Shan  1   2 , Xiao-Mei Feng  3 , Hong Liu  4 , Fu-Hai Ji  1   2 , Ke Peng  1   2
Affiliations

Deep Neuromuscular Blockade Combined with Low Pneumoperitoneum Pressure for Nociceptive Recovery After Major Laparoscopic Gastrointestinal Surgery: Study Protocol for a Randomized Controlled Trial

Yu-Qin Long et al. J Pain Res. .

Abstract

Purpose: Patients undergoing major laparoscopic surgery often experience significant pain and postoperative nausea and vomiting (PONV). Deep neuromuscular block (NMB) improves surgical conditions and facilitates the application of low intra-abdominal pressure (IAP), which may be beneficial for these patients. This study is designed to determine the effects of deep NMB combined with low IAP, as compared to moderate NMB combined with standard IAP, on patients' nociceptive recovery after major laparoscopic gastrointestinal surgery.

Study design and methods: This single-center randomized controlled trial will include 220 patients scheduled for major laparoscopic gastrointestinal surgery (lasts for ≥ 90 minutes). Patients will be randomly assigned, with a 1:1 ratio, into a deep NMB + low IAP group (train of four = 0, post-tetanic count = 1-3, IAP = 8 mmHg) and a moderate NMB + standard IAP group (train of four = 1-3, IAP = 12 mmHg). If the surgical workspace is inadequate, the surgeons can request a step increase of 1 mmHg in IAP during 3-min intervals. The upper limit of IAP will be set at 15 mmHg. Postoperative recovery will be assessed using the postoperative quality recovery scale (PQRS). The primary outcome of this trial is the PQRS nociceptive recovery (including pain and PONV) at postoperative day (POD) 1. The secondary outcomes include recovery in other PQRS domains at POD 1, and recovery in all PQRS domains in a post-anesthesia care unit, at POD 3 in the surgical wards, at hospital discharge, and at postoperative 30 days. For the sample size estimation, 110 patients in each group (220 in total) would be needed to detect an absolute increase rate of 20% in the PQRS nociceptive domain in the deep NMB + low IAP group at POD 1.

Discussion: This study investigates the effects of deep NMB combined with low IAP on postoperative PQRS nociceptive recovery in patients undergoing major laparoscopic gastrointestinal surgery. We expect that this deep NMB + low IAP strategy would improve postoperative pain and PONV following major laparoscopic gastrointestinal surgery.

Keywords: major laparoscopic surgery; neuromuscular block; pneumoperitoneum pressure; postoperative quality recovery scale; randomized controlled trial.

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Conflict of interest statement

The authors report no conflicts of interest in this work.

Figures

Figure 1
Figure 1
Study flow diagram.
Figure 2
Figure 2
Study plan and anesthesia management.
See this image and copyright information in PMC

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References

    1. Krielen P, Stommel MWJ, Pargmae P, et al. Adhesion-related readmissions after open and laparoscopic surgery: a retrospective cohort study (SCAR update). Lancet. 2020;395(10217):33–41. doi:10.1016/S0140-6736(19)32636-4 - DOI - PubMed
    1. Clinical Outcomes of Surgical Therapy Study Group. A comparison of laparoscopically assisted and open colectomy for colon cancer. N Engl J Med. 2004;350(20):2050–2059. - PubMed
    1. Kang SB, Park JW, Jeong SY, et al. Open versus laparoscopic surgery for mid or low rectal cancer after neoadjuvant chemoradiotherapy (COREAN trial): short-term outcomes of an open-label randomised controlled trial. Lancet Oncol. 2010;11(7):637–645. doi:10.1016/S1470-2045(10)70131-5 - DOI - PubMed
    1. Liu F, Huang C, Xu Z, et al. Morbidity and mortality of laparoscopic vs open total gastrectomy for clinical stage I gastric cancer: the CLASS02 multicenter randomized clinical trial. JAMA Oncol. 2020;6(10):1590–1597. doi:10.1001/jamaoncol.2020.3152 - DOI - PMC - PubMed
    1. van Vugt JL, Reisinger KW, Derikx JP, Boerma D, Stoot JH. Improving the outcomes in oncological colorectal surgery. World J Gastroenterol. 2014;20(35):12445–12457. doi:10.3748/wjg.v20.i35.12445 - DOI - PMC - PubMed