Comparison of Low Versus Normal Pressure Pneumoperitoneum - With Profound Low Versus Normal Pressure Pneumoperitoneum -With Profound Muscle Relaxation- During Laparoscopic Donor Nephrectomy — LEOPARD2  

Renal Disease Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pneumoperitoneum
• Renal Disease

• NCT number: NCT02146417
• Study type: Interventional
• Source: Radboud University
• Status: Completed
• Phase: N/A
• Start date: August 2014
• Completion date: October 2015