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; Xi-Sheng Shan; Xiao-Mei Feng; Hong Liu; Fu-Hai Ji; Ke Peng

doi:10.2147/JPR.S336870

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

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

Authors

Yu-Qin Long^{1

2}, Xi-Sheng Shan^{1

2}, Xiao-Mei Feng³, Hong Liu⁴, Fu-Hai Ji^{1

2}, Ke Peng^{1

2}

Affiliations

¹ Departments of Anesthesiology, First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, People's Republic of China.
² Institute of Anesthesiology, Soochow University, Suzhou, Jiangsu, People's Republic of China.
³ Department of Anesthesiology, University of Utah Health, Salt Lake City, UT, USA.
⁴ Department of Anesthesiology and Pain Medicine, University of California Davis Health, Sacramento, CA, USA.

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.

Grants and funding

This work will be supported by the Science and Technology Development Plan Clinical Trial Project (SLT201909 to FHJ) and Jiangsu Provincial Medical Youth Talents Program (QNRC2016741 to KP).