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Completed

NCT Number: NCT02146417

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Radboudumc

Nijmegen, Gelderland, 6500HB, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Low Pressure Pneumoperitoneum

Procedure

Normal pressure pneumoperitoneum (12 mmHg)

Procedure

Deep neuromuscular block

Procedure

Primary outcomes

  1. Quality-of-Recovery 40 scale

    Time frame: day 1

Secondary outcomes

  1. Cumulative use of opioids

    Time frame: Day -1;0;1;2;3 and Mon3

  2. Cumulative use of other analgetics

    Time frame: Day -1;0;1;2;3

  3. Post-operative complications

    Time frame: Day 0;1;2;3 and Month 3

  4. Time to reach discharge criteria

    Time frame: Day 0;1;2;3

Other outcomes

  1. Operation time

    Time frame: Peri-operative

  2. Length of pneumoperitoneum

    Time frame: Peri-operative

  3. Estimated blood loss

    Time frame: Peri-operative

  4. Intra-operative complications

    Time frame: Peri-operative

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study 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

Acronym: LEOPARD2

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 23, 2014
Registry last updated
Nov 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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