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

Not Applicable

Completed

• Conditions: Renal Disease
• Interventions: Procedure: Normal pressure pneumoperitoneum (12 mmHg); Procedure: Low pressure pneumoperitoneum; Procedure: Deep neuromuscular block

• Registration Number: NCT02146417
• Lead Sponsor: Radboud University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-05-21
• Study First Submitted QC: 2014-05-21
• Study First Posted: 2014-05-23
• Study Start: 2014-08
• Primary Completion: 2015-09
• Study Completion: 2015-10
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-09
• Last Update Posted: 2015-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• obtained informed consent
• age over 18 years

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal pressure pneumoperitoneum & deep neuromuscular block	Deep neuromuscular block	Normal pressure pneumoperitoneum
Low pressure pneumoperitoneum & deep neuromuscular block	Deep neuromuscular block	Low pressure pneumoperitoneum
Normal pressure pneumoperitoneum & deep neuromuscular block	Normal pressure pneumoperitoneum (12 mmHg)	Normal pressure pneumoperitoneum
Low pressure pneumoperitoneum & deep neuromuscular block	Low pressure pneumoperitoneum	Low pressure pneumoperitoneum

Primary Outcome Measures

Name	Time	Method
Quality-of-Recovery 40 scale	day 1

Secondary Outcome Measures

Name	Time	Method
Cumulative use of opioids	Day -1;0;1;2;3 and Mon3
Cumulative use of other analgetics	Day -1;0;1;2;3
Post-operative complications	Day 0;1;2;3 and Month 3
Time to reach discharge criteria	Day 0;1;2;3

Trial Locations

Locations (1)

Radboudumc; 🇳🇱 Nijmegen, Gelderland, Netherlands