Comparison of the effectiveness of low pressure pneumoperitoneum with profound muscle relaxation during laparoscopic donor nephrectomy to optimize the quality of recovery during the early post-operative phase: study protocol for a randomized controlled clinical trial.
BACKGROUND
Since technique modifications of laparoscopic donor nephrectomy, e.g. retroperitoneoscopic donor nephrectomy or hand-assistance, have not shown significant benefit regarding safety or improvement of recovery, further research should focus on improving postoperative recovery. The use of low pressure pneumoperitoneum has shown to significantly reduce postoperative pain after laparoscopy. To facilitate the use of low pressure pneumoperitoneum, deep neuromuscular block will be used.


METHODS
This trial is a phase IV, single center, double-blind, randomized controlled clinical trial in which 64 patients will be randomized to: low pressure pneumoperitoneum (6 mmHg) and deep neuromuscular block or normal pressure pneumoperitoneum (12 mmHg) and deep neuromuscular block. Deep neuromuscular block is defined as post tetanic count < 5. Primary outcome measurement will be Quality of Recovery-40 questionnaire (overall score) on day 1.


CONCLUSIONS
This study is the first randomized study to assess the combination of low pressure pneumoperitoneum in combination with deep neuromuscular block from a patients' perspective. The study findings may also be applicable for other laparoscopic procedures.


BACKGROUND
The trial was registered at trials.gov (NCT02146417) in July 2014.
Department of Surgery, Division of Vascular and Transplant Surgery, Radboud University Medical Center, Geert Grooteplein-Zuid 10, Nijmegen, 6525 GA, The Netherlands. Denise.Ozdemir-vanBrunschot@radboudumc.nl.
Denise M D
DM
Özdemir-van Brunschot
Department of Anesthesiology, Radboud University Medical Center, Nijmegen, The Netherlands. GertJan.Scheffer@radboudumc.nl.
Gert J
GJ
Scheffer
Department of Anesthesiology, Leiden University Medical Center, Leiden, The Netherlands. A.Dahan@lumc.nl.
Albert
A
Dahan
Department of Anesthesiology, Radboud University Medical Center, Nijmegen, The Netherlands. Janneke.Mulder@radboudumc.nl.
Janneke E E A
JE
Mulder
Department of Anesthesiology, Radboud University Medical Center, Nijmegen, The Netherlands. Willems@radboudumc.nl.
Simone A A
SA
Willems
Department of Nephrology, Radboud University Medical Center, Nijmegen, The Netherlands. Luuk.Hilbrands@radboudumc.nl.
Luuk B
LB
Hilbrands
Department of Urology, Radboud University Medical Center, Nijmegen, The Netherlands. Frank.dAncona@radboudumc.nl.
Frank C H
FC
d'Ancona
Department of Health Evidence, Radboud University Medical Center, Nijmegen, The Netherlands. Rogier.Donders@radboudumc.nl.
Rogier A R T
RA
Donders
Department of Surgery, Division of Vascular and Transplant Surgery, Radboud University Medical Center, Geert Grooteplein-Zuid 10, Nijmegen, 6525 GA, The Netherlands. Kees.vanLaarhoven@radboudumc.nl.
Kees J H M
KJ
van Laarhoven
Department of Surgery, Division of Vascular and Transplant Surgery, Radboud University Medical Center, Geert Grooteplein-Zuid 10, Nijmegen, 6525 GA, The Netherlands. Michiel.Warle@radboudumc.nl.
Michiel C
MC
Warlé
D002985:Clinical Protocols; D004311:Double-Blind Method; D006801:Humans; D016030:Kidney Transplantation / Q000379:methods*; D010535:Laparoscopy / Q000009:adverse effects; D019520:Living Donors; D009392:Nephrectomy / Q000009:adverse effects / Q000379:methods*; D009426:Netherlands; D019148:Neuromuscular Blockade / Q000009:adverse effects; D010147:Pain Measurement; D010149:Postoperative Pain / Q000209:etiology / Q000517:prevention & control; D011028:Pneumoperitoneum, Artificial / Q000009:adverse effects / Q000379:methods*; D020127:Recovery of Function; D012107:Research Design; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome