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Low-pressure pneumoperitoneum with deep neuromuscular blockade in metabolic surgery to reduce postoperative pain: a randomized pilot trial

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Abstract

Background

For metabolic laparoscopic surgery, higher pressures up to 20 mmHg are often used to create a surgical field of sufficient quality. This randomized pilot study aimed to determine the feasibility, safety and tolerability of low intraabdominal pressure (IAP) and deep neuromuscular blockade (NMB) to reduce postoperative pain.

Methods

In a teaching hospital in the Netherlands, 62 patients eligible for a laparoscopic Roux-en-Y gastric bypass (LRYGB) were randomized into one of four groups in a 2 × 2 factorial design: deep/moderate NMB and standard (20 mmHg)/low IAP (12 mmHg). Patient and surgical team were blinded. Primary outcome measure was the surgical field quality, scored on the Leiden-Surgical Rating Scale (L-SRS). Secondary outcome measures were (serious) adverse events, duration of surgery and postoperative pain.

Results

62 patients were included. L-SRS was good or perfect in all patients that were operated under standard IAP with deep or moderate NMB. In 40% of patients with low IAP and deep NMB, an increase in IAP was needed to improve surgical overview. In patients with low IAP and moderate NMB, IAP was increased to improve surgical overview in 40%, and in 75% of these cases a deep NMB was requested to further improve the surgical overview. Median duration of surgery was 38 min (IQR34-40 min) in the group with standard IAP and moderate NMB and 52 min (IQR46-55 min) in the group with low IAP and deep NMB.

Conclusions

The combination of moderate NMB and low IAP can create insufficient surgical overview. Larger trials are needed to corroborate the findings of this study.

Trial registration: Dutch Trial Register: Trial NL7050, registered 28 May 2018. https://www.trialregister.nl/trial/7050.

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Acknowledgements

Special thanks to the dedicated bariatric OR team, Joeri Slob, Henneke Kok, Niels Simmons, Rianne Raatgever and Patricia de Haan, and to Hans Zengerink, Irene Friskes, Julie Wijnand, Zenaida Soares, Heleen van Biezen and Cees Verhoef for their support during this pilot study.

Funding

None.

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Authors and Affiliations

  1. Department of Surgery, Franciscus Gasthuis & Vlietland, Kleiweg 500, 3045 PM, Rotterdam, The Netherlands

    Marjolijn Leeman, L. Ulas Biter, Jan A. Apers & Martin Dunkelgrun

  2. Department of Statistics and Education, Franciscus Gasthuis & Vlietland, Rotterdam, The Netherlands

    Erwin Birnie

  3. Department of Genetics, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands

    Erwin Birnie

  4. Department of Anesthesiology, Franciscus Gasthuis & Vlietland, Rotterdam, The Netherlands

    Serge J. C. Verbrugge

Authors
  1. Marjolijn Leeman
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  2. L. Ulas Biter
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  3. Jan A. Apers
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  4. Erwin Birnie
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  5. Serge J. C. Verbrugge
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  6. Martin Dunkelgrun
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Corresponding author

Correspondence to Marjolijn Leeman.

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Disclosures

Drs. Leeman, Drs. Biter, Drs. Apers, Dr. Birnie, Dr. Verbrugge and Dr. Dunkelgrun have no conflicts of interest or financial ties to disclose.

Ethics approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Informed consent was obtained from all individual participants included in the study. The study protocol was approved by the institutional review board (IRB) and the regional Medical Research Ethics Committee TWOR, Rotterdam, the Netherlands (Registration Number NL64025.101.17 and Protocol Number 2018–80).

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Leeman, M., Biter, L.U., Apers, J.A. et al. Low-pressure pneumoperitoneum with deep neuromuscular blockade in metabolic surgery to reduce postoperative pain: a randomized pilot trial. Surg Endosc 35, 2838–2845 (2021). https://doi.org/10.1007/s00464-020-07719-w

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  • DOI: https://doi.org/10.1007/s00464-020-07719-w

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