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

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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02146417
Acronym
LEOPARD2
Enrollment
64
Registered
2014-05-23
Start date
2014-08-31
Completion date
2015-10-31
Last updated
2015-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Disease

Keywords

Low pressure pneumoperitoneum, Deep neuromuscular block

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.

Interventions

PROCEDURENormal pressure pneumoperitoneum (12 mmHg)

Sponsors

Merck Sharp & Dohme LLC
CollaboratorINDUSTRY
Radboud University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
Quality-of-Recovery 40 scaleday 1

Secondary

MeasureTime frame
Cumulative use of opioidsDay -1;0;1;2;3 and Mon3
Cumulative use of other analgeticsDay -1;0;1;2;3
Post-operative complicationsDay 0;1;2;3 and Month 3
Time to reach discharge criteriaDay 0;1;2;3

Other

MeasureTime frame
Length of pneumoperitoneumPeri-operative
Estimated blood lossPeri-operative
Intra-operative complicationsPeri-operative
Operation timePeri-operative

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026