A phase IV, blinded, randomized controlled trial to compare the effectiveness of low pressure pneumoperitoneum during laparoscopic donor nephrectomy to optimize the quality-of-recovery during the early post-operative phase

As both patients with end-stage kidney disease and society benefit tremendously
from live kidney donation, the safety and well-being of kidney donors are
highly important objectives in live kidney donation. Laparoscopic donor
nephrectomy has several advantages over open donor nephrectomy, such as less
post-operative pain, better quality of life and shorter hospital stay1.
Therefore, laparoscopic donor nephrectomy is nowadays the treatment of choice.
So far, modifications of the technique of laparoscopic donor nephrectomy, i.e.
hand-assisted and/or retroperitoneoscopic approaches, did not show a
significant benefit with regard to safety as reflected by the conversion to
open and postoperative complication rate2-4. We therefore believe that further
research should focus on the optimization of early postoperative recovery.
Postoperative recovery is largely determined by the consequences of
postoperative pain and its concomitant use of opioids. Since non-steroidal
anti-inflammatory drugs are contra-indicated during and after nephrectomy, the
management of postoperative pain largely depends on the administration of
opioids. Measures to reduce postoperative pain would also reduce the occurrence
of postoperative drowsiness, nausea and vomitus, and postoperative bowel
dysfunction.
Pain after laparoscopic surgery can be divided into three components: a)
superficial wound pain, b) deep intra-abdominal pain and c) referred shoulder
pain5. A recent pilot study performed by our group showed that the use of low
pressure pneumoperitoneum (7 mmHg) was feasible and significantly reduced deep
intra-abdominal and referred pain scores during the first 72 hours after
surgery6. Previous studies by others show that low pressure pneumoperitoneum
during laparoscopic Nissen fundoplication and laparoscopic cholecystectomy is
associated with a reduction of the systemic inflammatory response, less adverse
impact on the peritoneal environment, post-operative pain and analgesic
consumption7-10.

To facilitate the use of low pressure pneumoperitoneum and to optimize the
quality of the surgical conditions (which in theory increases safety of the low
pressure pneumoperitoneum), muscle relaxation will be standardized throughout
the procedure. In our current practice higher doses of rocuronium are used for
laparoscopic donor nephrectomy as compared to standard laparoscopic procedures
(e.g. laparoscopic cholecystectomy). To facilitate recovery, suggamadex is used
on a regular basis to antagonize the effects of muscle relaxation. Currently, a
non-invasive device, the acceleromyograph at the wrist (TOF-watch-SX, MSD), is
used to monitor the depth of muscle relaxation aiming at a train-of-four (TOF)
below 2. In our study we use the same device to measure the post tetanic count
(PTC), aiming at a count of 1 or 2 which is defined as *deep* muscle
relaxation. Instead of additional boluses of rocuronium, a continuous infusion
with rocuronium will be used to guarantee a steady PTC of 1 or 2 during the
whole procedure. After surgery all patients will receive suggamadex to rapidly
antagonize the effects of muscle relaxation. This guarantees that the
participants are not exposed to any additional burden related to the use of
*deep* muscle relaxation.

Referenties
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for live kidney donors, Cochrane Database Syst Revi 2011;11:CD006124
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To investigate whether the use of low pressure pneumoperitoneum during
laparoscopic donor nephrectomy improves the quality-of-recovery during the
early post-operative phase as compared to the use of standard pressure
pneumoperitoneum.

Single-center, single-blind, randomized, controlled clinical trial

The patient will be randomized in one the following study groups:
• Standard pressure pneumoperitoneum (12 mmHg)
• Low pressure pneumoperitoneum (6 mmHg)

The patient will be asked to fill in some questionnaires:
• Quality of recovery-40: 5x 5 minutes = 25 minutes
• Return to work: 3x 5 minutes = 15 minutes
• Components of pain assessment: 7x 2 minutes = 14 minutes
• Nausea score = 5x 1 minute = 5 minutes
Total estimated 59 minutes