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

Renal Disease Clinical Trial

— LEOPARD2  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02146417
• Other study ID #: MISP#51414
• Status: Completed
• Phase: N/A
• First received: May 21, 2014
• Last updated: November 9, 2015
• Start date: August 2014
• Est. completion date: October 2015

Study information

• Verified date: November 2015
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: October 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

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

Intervention

Procedure:
• Low pressure pneumoperitoneum

• Normal pressure pneumoperitoneum (12 mmHg)

• Deep neuromuscular block

Locations

Country	Name	City	State
Netherlands	Radboudumc	Nijmegen	Gelderland

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Operation time		Peri-operative	No
Other	Length of pneumoperitoneum		Peri-operative	No
Other	Estimated blood loss		Peri-operative	Yes
Other	Intra-operative complications		Peri-operative	Yes
Primary	Quality-of-Recovery 40 scale		day 1	No
Secondary	Cumulative use of opioids		Day -1;0;1;2;3 and Mon3	No
Secondary	Cumulative use of other analgetics		Day -1;0;1;2;3	No
Secondary	Post-operative complications		Day 0;1;2;3 and Month 3	Yes
Secondary	Time to reach discharge criteria		Day 0;1;2;3	No