Clinical Trial: Comparison of Low Versus Normal Pressure Pneumoperitoneum - With Profound Low Versus Normal Pressure Pneumoperitoneum -With Profound Muscle Relaxation- During Laparoscopic Donor Nephrectomy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 sur

Detailed Summary:
Sponsor: Radboud University

Current Primary Outcome: Quality-of-Recovery 40 scale [ Time Frame: day 1 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Cumulative use of opioids [ Time Frame: Day -1;0;1;2;3 and Mon3 ]
  • Cumulative use of other analgetics [ Time Frame: Day -1;0;1;2;3 ]
  • Post-operative complications [ Time Frame: Day 0;1;2;3 and Month 3 ]
  • Time to reach discharge criteria [ Time Frame: Day 0;1;2;3 ]


Original Secondary Outcome: Same as current

Information By: Radboud University

Dates:
Date Received: May 21, 2014
Date Started: August 2014
Date Completion:
Last Updated: November 9, 2015
Last Verified: November 2015