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

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
intrathecal morphine
Morphine PCA
Ropivacaine infiltration
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring Intrathecal morphine, continuous wound infiltration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CHRU , Hôpital Claude Huriez

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Ropivacaine infiltration

intrathecal morphine

morphine PCA

Arm Description

Continuous infiltration of local anesthetics + PCA morphine.

Rachianalgesia + PCA morphine

PCA morphine alone

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Morphine Consumption
Morphine consumption is measured all 3 hours during the 48 hours post operative
Evaluation of postoperative pain intensity at rest
The postoperative pain intensity is measured by Visual Analog Scale at rest
Evaluation of postoperative pain intensity after activity
The postoperative pain intensity is measured by Visual Analog Scale after activity
Electric nociception threshold measured by PainMatcher
The Electric nociception threshold is measured by PainMatcher (CefarCompex®)
Electric nociception threshold measured by PainMatcher
The Electric nociception threshold is measured by PainMatcher (CefarCompex®)
Electric nociception threshold measured by PainMatcher
The Electric nociception threshold is measured by PainMatcher (CefarCompex®)
Number of patient with a chronic pain after liver surgery, measured by Questionnaire Douleur de Saint-Antoine (QDSA)
Evaluation with validated score for chronic and neuropathic pains (QDSA is the French translation of the MPQ "Mac Gill bread questionary")
Number of patient with a chronic pain after liver surgery, measured by Questionnaire Douleur de Saint-Antoine (QDSA)
Evaluation with validated score for chronic and neuropathic pains (QDSA is the French translation of the MPQ "Mac Gill bread questionary")
Number of patient with a chronic pain after liver surgery, measured by Neuropathic Pain Symptom Inventory (NPSI)
Evaluation with validated score for chronic and neuropathic pains (NPSI)
Number of patient with a chronic pain after liver surgery, measured by Neuropathic Pain Symptom Inventory (NPSI),
Evaluation with validated score for chronic and neuropathic pains (NPSI)
Number of patient with a chronic pain after liver surgery, measured by Neuropathic pain diagnostic questionnaire (DN2),
Evaluation with validated score for chronic and neuropathic pains (DN2)
Number of patient with a chronic pain after liver surgery, measured by Neuropathic pain diagnostic questionnaire (DN2),
Evaluation with validated score for chronic and neuropathic pains (DN2)
Area peri-incisional hyperalgesia
The Surface of the cutaneous Area peri-incisional hyperalgesia is measured by Von frey's Filament.
Number of nausea and/or vomiting episodes
Measured by collection of episodes of nausea and/or vomiting and consumption of anti-emetics
Number of nausea and/or vomiting episodes
Measured by collection of episodes of nausea and/or vomiting and consumption of anti-emetics
Number of nausea and/or vomiting episodes
Measured by collection of episodes of nausea and/or vomiting and consumption of anti-emetics
Number of patient with side effect of morphine consumption
Respiratory Depression, Urinary retention, Prurit
Time physiological function recovery
Nasogastric tube withdrawal time, Transit recovery, Ability to drink, to eat, to urinate, to walk
Length of hospital stay in intensive care unit
Length of hospital stay

Full Information

First Posted
July 31, 2017
Last Updated
October 13, 2022
Sponsor
University Hospital, Lille
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1. Study Identification

Unique Protocol Identification Number
NCT03238430
Brief Title
Management of Pain Post Hepatectomy : Infiltration of Local Anesthetics Versus Continuous Spinal Analgesia .
Acronym
CATHEPAT
Official Title
Management of Pain Post Hepatectomy : Infiltration of Local Anesthetics Versus Continuous Spinal Analgesia .
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
May 20, 2015 (Actual)
Primary Completion Date
May 25, 2019 (Actual)
Study Completion Date
May 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
Intrathecal morphine, continuous wound infiltration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
186 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ropivacaine infiltration
Arm Type
Experimental
Arm Description
Continuous infiltration of local anesthetics + PCA morphine.
Arm Title
intrathecal morphine
Arm Type
Experimental
Arm Description
Rachianalgesia + PCA morphine
Arm Title
morphine PCA
Arm Type
Active Comparator
Arm Description
PCA morphine alone
Intervention Type
Drug
Intervention Name(s)
intrathecal morphine
Intervention Description
A single intrathecal injection of 300 micrograms of Morphine preoperatively, just before induction.
Intervention Type
Drug
Intervention Name(s)
Morphine PCA
Intervention Description
a postoperative Morphine PCA
Intervention Type
Drug
Intervention Name(s)
Ropivacaine infiltration
Intervention Description
Ropivacaine 2mg / ml at the rate of 8ml per hour via a multiperforated catheter with connector after bolus of 20 ml
Primary Outcome Measure Information:
Title
Morphine Consumption
Description
Morphine consumption is measured all 3 hours during the first 24 hours post operative
Time Frame
During the first 24 hours post operative
Secondary Outcome Measure Information:
Title
Morphine Consumption
Description
Morphine consumption is measured all 3 hours during the 48 hours post operative
Time Frame
During the 48 hours post operative
Title
Evaluation of postoperative pain intensity at rest
Description
The postoperative pain intensity is measured by Visual Analog Scale at rest
Time Frame
All 3 hours during the 48 postoperative hours
Title
Evaluation of postoperative pain intensity after activity
Description
The postoperative pain intensity is measured by Visual Analog Scale after activity
Time Frame
All 3 hours during the 48 postoperative hours
Title
Electric nociception threshold measured by PainMatcher
Description
The Electric nociception threshold is measured by PainMatcher (CefarCompex®)
Time Frame
At the exit of Post Anesthesia Care Unit
Title
Electric nociception threshold measured by PainMatcher
Description
The Electric nociception threshold is measured by PainMatcher (CefarCompex®)
Time Frame
At 24 hours post operative
Title
Electric nociception threshold measured by PainMatcher
Description
The Electric nociception threshold is measured by PainMatcher (CefarCompex®)
Time Frame
At 48 hours post operative
Title
Number of patient with a chronic pain after liver surgery, measured by Questionnaire Douleur de Saint-Antoine (QDSA)
Description
Evaluation with validated score for chronic and neuropathic pains (QDSA is the French translation of the MPQ "Mac Gill bread questionary")
Time Frame
At 3 months after surgery
Title
Number of patient with a chronic pain after liver surgery, measured by Questionnaire Douleur de Saint-Antoine (QDSA)
Description
Evaluation with validated score for chronic and neuropathic pains (QDSA is the French translation of the MPQ "Mac Gill bread questionary")
Time Frame
At 6 months after surgery
Title
Number of patient with a chronic pain after liver surgery, measured by Neuropathic Pain Symptom Inventory (NPSI)
Description
Evaluation with validated score for chronic and neuropathic pains (NPSI)
Time Frame
At 3 months after surgery
Title
Number of patient with a chronic pain after liver surgery, measured by Neuropathic Pain Symptom Inventory (NPSI),
Description
Evaluation with validated score for chronic and neuropathic pains (NPSI)
Time Frame
At 6 months after surgery
Title
Number of patient with a chronic pain after liver surgery, measured by Neuropathic pain diagnostic questionnaire (DN2),
Description
Evaluation with validated score for chronic and neuropathic pains (DN2)
Time Frame
At 3 months after surgery
Title
Number of patient with a chronic pain after liver surgery, measured by Neuropathic pain diagnostic questionnaire (DN2),
Description
Evaluation with validated score for chronic and neuropathic pains (DN2)
Time Frame
At 6 months after surgery
Title
Area peri-incisional hyperalgesia
Description
The Surface of the cutaneous Area peri-incisional hyperalgesia is measured by Von frey's Filament.
Time Frame
At 48 hours post operative
Title
Number of nausea and/or vomiting episodes
Description
Measured by collection of episodes of nausea and/or vomiting and consumption of anti-emetics
Time Frame
At 24 hours after surgery
Title
Number of nausea and/or vomiting episodes
Description
Measured by collection of episodes of nausea and/or vomiting and consumption of anti-emetics
Time Frame
At 48 hours after surgery
Title
Number of nausea and/or vomiting episodes
Description
Measured by collection of episodes of nausea and/or vomiting and consumption of anti-emetics
Time Frame
At 72 hours after surgery
Title
Number of patient with side effect of morphine consumption
Description
Respiratory Depression, Urinary retention, Prurit
Time Frame
Up to 72 hours after surgery
Title
Time physiological function recovery
Description
Nasogastric tube withdrawal time, Transit recovery, Ability to drink, to eat, to urinate, to walk
Time Frame
Up to the end of hospital stay, an average 10 days
Title
Length of hospital stay in intensive care unit
Time Frame
Up to the end of hospital stay,an average 10 days
Title
Length of hospital stay
Time Frame
Up to the end of hospital stay , an average 10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilles Lebuffe, MD, PhD
Organizational Affiliation
CHRU de Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU , Hôpital Claude Huriez
City
Lille
Country
France

12. IPD Sharing Statement

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