NCT03238430

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
186

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2015

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 20, 2015

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

July 31, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 3, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2019

Completed
Last Updated

December 22, 2025

Status Verified

August 1, 2020

Enrollment Period

4 years

First QC Date

July 31, 2017

Last Update Submit

December 15, 2025

Conditions

Pain, Postoperative

Keywords

Intrathecal morphine, continuous wound infiltration

Outcome Measures

Primary Outcomes (1)

  • Morphine Consumption

    Morphine consumption is measured all 3 hours during the first 24 hours post operative

    During the first 24 hours post operative

Secondary Outcomes (20)

  • Morphine Consumption

    During the 48 hours post operative

  • Evaluation of postoperative pain intensity at rest

    All 3 hours during the 48 postoperative hours

  • Evaluation of postoperative pain intensity after activity

    All 3 hours during the 48 postoperative hours

  • Electric nociception threshold measured by PainMatcher

    At the exit of Post Anesthesia Care Unit

  • Electric nociception threshold measured by PainMatcher

    At 24 hours post operative

  • +15 more secondary outcomes

Study Arms (3)

Ropivacaine infiltration

EXPERIMENTAL

Continuous infiltration of local anesthetics + PCA morphine.

Drug: intrathecal morphineDrug: Morphine PCA

intrathecal morphine

EXPERIMENTAL

Rachianalgesia + PCA morphine

Drug: Morphine PCADrug: Ropivacaine infiltration

morphine PCA

ACTIVE COMPARATOR

PCA morphine alone

Drug: Morphine PCA

Interventions

intrathecal morphineDRUG

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

Ropivacaine infiltration
Morphine PCADRUG

a postoperative Morphine PCA

Ropivacaine infiltrationintrathecal morphinemorphine PCA
Ropivacaine infiltrationDRUG

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

intrathecal morphine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU , Hôpital Claude Huriez

Lille, France

Location

Related Publications (1)

  • 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.

    PMID: 40662757RESULT

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Gilles Lebuffe, MD, PhD

    CHRU de Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2017

First Posted

August 3, 2017

Study Start

May 20, 2015

Primary Completion

May 25, 2019

Study Completion

May 25, 2019

Last Updated

December 22, 2025

Record last verified: 2020-08

Locations

FR(1)