UnknownNot Applicable

Spinal Versus Epidural Analgesia in Laparotomic Liver Surgery

Italy40 participantsStarted 2016-01

Plain-language summary

The purpose of this study is to evaluate the efficacy of spinal analgesia for minor laparotomic hepatectomy compared with epidural analgesia, monitoring visual analog scale (VAS). The investigators expect at least the same post-operative pain control in the two groups (non inferiority of pain control with spinal analgesia compared to epidural analgesia). Second endpoint is to verify whether after spinal analgesia there is a decrease in patient's length of hospitalization according to enhanced recovery after surgery (ERAS) principles.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age \> 18 years old * Hospitalized patients * Surgical indication for minor laparotomic anterior liver resection (II, III, IV and V hepatic segment resection) * Surgical indication for laparotomic liver metastasectomy * Ability to provide an informed consent Exclusion Criteria: * Patient refusal to provide informed consent * Chronical therapy with opioids * Pregnancy or breastfeeding * Alcohol or drug abuse * Planned or unplanned post-operative intensive care unit admission * Contraindication to spinal/epidural analgesia * Severe liver or renal failure * Cognitive disorders, mental retard or psychiatric disorders * Allergy to any drug used

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Assessment of postoperative pain control by mean of the visual analog scale early after surgery

Timeframe: Within 1 hour after surgery

Assessment of postoperative pain control by mean of the visual analog scale six hours after surgery

Timeframe: 6 hours after surgery

Assessment of postoperative pain control by mean of the visual analog scale one day after surgery

Timeframe: 24 hours after surgery

Assessment of postoperative pain control by mean of the visual analog scale two days after surgery

Timeframe: 48 hours after surgery

Assessment of postoperative pain control by mean of the visual analog scale three days after surgery

Timeframe: 72 hours after surgery

Assessment of postoperative pain control by mean of the visual analog scale at hospital discharge

Timeframe: Up to 30 days after surgery

Trial details

NCT IDNCT02647047

SponsorOspedale San Raffaele

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-11

Contact for this trial

Elena Bignami, M.D.

+39.02.2643.4524 bignami.elena@hsr.it

View on ClinicalTrials.gov More Secondary Malignant Neoplasm of Liver trials