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Management of Pain Post Hepatectomy : Infiltration of Local Anesthetics Versus Continuous Spinal Analgesia .

NCT ID: NCT03238430

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

186 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-20

Study Completion Date

2019-05-25

Brief Summary

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Analgesia in liver surgery is a challenge, postoperative coagulopathy risk raises fears an epidural haematoma formation following the epidural analgesia, "gold standard" in major abdominal surgery. The spinal analgesia and/or continuous wound infiltration of local anesthetics constitute so an alternative.

The study will compare the continuous infiltration of local anesthetics and rachianalgesia in terms of decreased postoperative morphine consumption and incidences of chronic postoperative pain at 3 and 6 months after hepatic surgery compared to the control group.

Detailed Description

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Conditions

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Pain, Postoperative

Keywords

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Intrathecal morphine, continuous wound infiltration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ropivacaine infiltration

Continuous infiltration of local anesthetics + PCA morphine.

Group Type EXPERIMENTAL

intrathecal morphine

Intervention Type DRUG

A single intrathecal injection of 300 micrograms of Morphine preoperatively, just before induction.

Morphine PCA

Intervention Type DRUG

a postoperative Morphine PCA

intrathecal morphine

Rachianalgesia + PCA morphine

Group Type EXPERIMENTAL

Morphine PCA

Intervention Type DRUG

a postoperative Morphine PCA

Ropivacaine infiltration

Intervention Type DRUG

Ropivacaine 2mg / ml at the rate of 8ml per hour via a multiperforated catheter with connector after bolus of 20 ml

morphine PCA

PCA morphine alone

Group Type ACTIVE_COMPARATOR

Morphine PCA

Intervention Type DRUG

a postoperative Morphine PCA

Interventions

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intrathecal morphine

A single intrathecal injection of 300 micrograms of Morphine preoperatively, just before induction.

Intervention Type DRUG

Morphine PCA

a postoperative Morphine PCA

Intervention Type DRUG

Ropivacaine infiltration

Ropivacaine 2mg / ml at the rate of 8ml per hour via a multiperforated catheter with connector after bolus of 20 ml

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Surgery of hepatic resection by first under costal.
* Patient classified ASA 1 to 3.
* Information, signed and informed consent

Exclusion Criteria

* Patients classified ASA 4 or 5.
* Allergy or intolerance to any of the products used in the protocol.
* Emergency surgery, palliative surgery, surgical recovery.
* History of chronic pain requiring the regular use of analgesics, especially opioids.
* History of drug misuse.
* Inability to understand and / or use the patient's self-controlled morphine pump.
* Known history of psychiatric disorders or current psychotropic treatment (excluding benzodiazepine monotherapy)
* Additive behavior with respect to alcohol or non-weaned psychodysleptic substances
* Pregnant Woman or Breastfeeding
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gilles Lebuffe, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHRU de Lille

Locations

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CHRU , Hôpital Claude Huriez

Lille, , France

Site Status

Countries

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France

References

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Rousseleau D, Plane B, Labreuche J, Pierache A, El Amine Y, Ethgen S, Wattier JM, Cirenei C, Boleslawski E, Lebuffe G. Comparison of catheter wound infusion, intrathecal morphine, and intravenous analgesia for postoperative pain management in open liver resection: randomized clinical trial. BJS Open. 2025 Jul 1;9(4):zraf074. doi: 10.1093/bjsopen/zraf074.

Reference Type RESULT
PMID: 40662757 (View on PubMed)

Other Identifiers

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2014-003317-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2013_48

Identifier Type: -

Identifier Source: org_study_id