Clinical trial NCT02146417: Comparison of Low Versus Normal Pressure Pneumoperitoneum - With Profound Low Versus Normal Pressure Pneumoperitoneum -With Profound Muscle Relaxation- During Laparoscopic Donor Nephrectomy
Official title: A Phase IV, Blinded, Randomized Controlled Trial to Compare 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Disease
Keywords: Low pressure pneumoperitoneum
Deep neuromuscular block
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2014-05-23
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 nephrectomy, such as less post-operative pain, better quality of life and shorter hospital stay. Therefore, laparoscopic donor nephrectomy is nowadays the treatment of choice in most countries.

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 complications rate. We therefore believe that further research should focus on the optimization of early postoperative pain and its concomitant use of opioids. Since non-steroidal anti-inflammatory drugs are contra-indicated before 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 nausea and vomitus, and postoperative bowel dysfunction.

A recent pilot study performed by our group showed that the use of low pressure pneumoperitoneum was feasible and significantly reduced deep intra-abdominal and referred pain score during the first 72 hours after surgery. Previous studies performed by others show that low pressure pneumoperitoneum is associated with reduction of systemic inflammatory response, post-operative pain and analgesic consumption. Martini et al have shown that deep neuromuscular block improves surgical conditions during laparoscopic surgery with standard intra-abdominal pressure. To facilitate the use of low pressure pneumoperitoneum, deep neuromuscular block improves surgical conditions and might become a prerequisite for the use of low pressure pneumoperitoneum.

Our hypothesis is that the combination of low pressure pneumoperitoneum and deep neuromuscular block improves quality of recovery in the early post-operative phase.


Eligibility criteria: Inclusion Criteria:

* obtained informed consent
* age over 18 years

Exclusion Criteria:

* insufficient control of the Dutch language to read the patient information and to fill out the questionnaires
* chronic use of analgesics or psychotropic drugs
* use of non-steroidal anti-inflammatory drugs shorter than 5 days before surgery
* known or suspect allergy to rocuronium or sugammadex
* significant liver\* or renal\*\* dysfunction
* neuromuscular disease
* pregnant of breastfeeding
* indication for rapid sequence induction

  * liver dysfunction is defined as alanine aminotransferase (ALAT) and/or aspartate aminotransferase (ASAT) \> twice the upper limit (extremely rare in live kidney donors) \*\* renal dysfunction is defined as serum creatinine twice the normal level and/or glomerular filtration rate \< 60 ml/min (extremely rare in live kidney donors)

Primary outcomes:
measure: Quality-of-Recovery 40 scale
timeFrame: day 1
Secondary outcomes:
measure: Cumulative use of opioids
timeFrame: Day -1;0;1;2;3 and Mon3
measure: Cumulative use of other analgetics
timeFrame: Day -1;0;1;2;3
measure: Post-operative complications
timeFrame: Day 0;1;2;3 and Month 3
measure: Time to reach discharge criteria
timeFrame: Day 0;1;2;3
Other outcomes:
measure: Operation time
timeFrame: Peri-operative
measure: Length of pneumoperitoneum
timeFrame: Peri-operative
measure: Estimated blood loss
timeFrame: Peri-operative
measure: Intra-operative complications
timeFrame: Peri-operative
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
state: Gelderland
Study officials:
affiliation: Radboud University Medical Center
name: Michiel Warlé, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reijnders-Boerboom GTJA, van Helden EV, Minnee RC, Albers KI, Bruintjes MHD, Dahan A, Martini CH, d'Ancona FCH, Scheffer GJ, Keijzer C, Warle MC. Deep neuromuscular block reduces the incidence of intra-operative complications during laparoscopic donor nephrectomy: a pooled analysis of randomized controlled trials. Perioper Med (Lond). 2021 Dec 9;10(1):56. doi: 10.1186/s13741-021-00224-1.
citation: Albers KI, van Helden EV, Dahan A, Martini CH, Bruintjes MHD, Scheffer GJ, Steegers MAH, Keijzer C, Warle MC. Early postoperative pain after laparoscopic donor nephrectomy predicts 30-day postoperative infectious complications: a pooled analysis of randomized controlled trials. Pain. 2020 Jul;161(7):1565-1570. doi: 10.1097/j.pain.0000000000001842.
citation: Ozdemir-van Brunschot DMD, Scheffer GJ, van der Jagt M, Langenhuijsen H, Dahan A, Mulder JEEA, Willems S, Hilbrands LB, Donders R, van Laarhoven CJHM, d'Ancona FA, Warle MC. Quality of Recovery After Low-Pressure Laparoscopic Donor Nephrectomy Facilitated by Deep Neuromuscular Blockade: A Randomized Controlled Study. World J Surg. 2017 Nov;41(11):2950-2958. doi: 10.1007/s00268-017-4080-x.
citation: Ozdemir-van Brunschot DM, Scheffer GJ, Dahan A, Mulder JE, Willems SA, Hilbrands LB, d'Ancona FC, Donders RA, van Laarhoven KJ, Warle MC. 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. Trials. 2015 Aug 12;16:345. doi: 10.1186/s13063-015-0887-7.