Pain, PostoperativePhase 2/3CATHEPATNCT03238430
Management of Pain Post Hepatectomy : Infiltration of Local Anesthetics Versus Continuous Spinal Analgesia .
A Phase 2/3 study testing intrathecal morphine, Morphine PCA and Ropivacaine infiltration in people with Pain, Postoperative, run by University Hospital, Lille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- intrathecal morphine, Morphine PCA and Ropivacaine infiltration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteFrance
- Study dates
- 20 May 2015to 25 May 2019
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Surgery of hepatic resection by first under costal.
- Patient classified ASA 1 to 3.
- Information, signed and informed consent
Who cannot join
- 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.
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Pain, Postoperative
- Being tested
- intrathecal morphine, Morphine PCA, Ropivacaine infiltration
- Keywords
- Intrathecal morphine, continuous wound infiltration
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intrathecal morphineDrug
A single intrathecal injection of 300 micrograms of Morphine preoperatively, just before induction.
Morphine PCADrug
a postoperative Morphine PCA
Ropivacaine infiltrationDrug
Ropivacaine 2mg / ml at the rate of 8ml per hour via a multiperforated catheter with connector after bolus of 20 ml
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine infiltration | Experimental | Continuous infiltration of local anesthetics + PCA morphine. Receives: Drug: intrathecal morphine; Drug: Morphine PCA |
| intrathecal morphine | Experimental | Rachianalgesia + PCA morphine Receives: Drug: Morphine PCA; Drug: Ropivacaine infiltration |
| morphine PCA | Active comparator | PCA morphine alone Receives: Drug: Morphine PCA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine Consumption
Morphine consumption is measured all 3 hours during the first 24 hours post operative
Measured: During the first 24 hours post operative
Secondary outcomes (20)
Morphine Consumption
Morphine consumption is measured all 3 hours during the 48 hours post operative
Measured: 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
Measured: All 3 hours during the 48 postoperative hours
Evaluation of postoperative pain intensity after activity
The postoperative pain intensity is measured by Visual Analog Scale after activity
Measured: All 3 hours during the 48 postoperative hours
Electric nociception threshold measured by PainMatcher
The Electric nociception threshold is measured by PainMatcher (CefarCompex®)
Measured: At the exit of Post Anesthesia Care Unit
Electric nociception threshold measured by PainMatcher
The Electric nociception threshold is measured by PainMatcher (CefarCompex®)
Measured: At 24 hours post operative
Electric nociception threshold measured by PainMatcher
The Electric nociception threshold is measured by PainMatcher (CefarCompex®)
Measured: At 48 hours post operative
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")
Measured: At 3 months after surgery
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")
Measured: At 6 months after surgery
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)
Measured: At 3 months after surgery
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)
Measured: At 6 months after surgery
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)
Measured: At 3 months after surgery
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)
Measured: At 6 months after surgery
Area peri-incisional hyperalgesia
The Surface of the cutaneous Area peri-incisional hyperalgesia is measured by Von frey's Filament.
Measured: At 48 hours post operative
Number of nausea and/or vomiting episodes
Measured by collection of episodes of nausea and/or vomiting and consumption of anti-emetics
Measured: At 24 hours after surgery
Number of nausea and/or vomiting episodes
Measured by collection of episodes of nausea and/or vomiting and consumption of anti-emetics
Measured: At 48 hours after surgery
Number of nausea and/or vomiting episodes
Measured by collection of episodes of nausea and/or vomiting and consumption of anti-emetics
Measured: At 72 hours after surgery
Number of patient with side effect of morphine consumption
Respiratory Depression, Urinary retention, Prurit
Measured: Up to 72 hours after surgery
Time physiological function recovery
Nasogastric tube withdrawal time, Transit recovery, Ability to drink, to eat, to urinate, to walk
Measured: Up to the end of hospital stay, an average 10 days
Length of hospital stay in intensive care unit
Measured: Up to the end of hospital stay,an average 10 days
Length of hospital stay
Measured: Up to the end of hospital stay , an average 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2017
- Study start20 May 2015
- Primary completion25 May 2019
- Study completion25 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gilles Lebuffe, MD, PhD, Principal investigator, CHRU de Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03238430
- Sponsor's protocol ID
- 2013_48
- Other IDs
- 2014-003317-28, 2014
- Acronym
- CATHEPAT
- Status last verified
- Aug 2020
- First submitted
- 31 Jul 2017
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40662757
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Pain Post Hepatectomy : Infiltration of Local Anesthetics Versus Continuous Spinal Analgesia .
- ClinicalTrials.gov ID
- NCT03238430
- Acronym / sponsor ID
- CATHEPAT / 2013_48
- Conditions
- Pain, Postoperative
- Keywords
- Intrathecal morphine, continuous wound infiltration
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 20 May 2015 (actual)
- Primary completion
- 25 May 2019 (actual)
- Study completion
- 25 May 2019 (actual)
- First posted
- 3 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine infiltration | Experimental | Drug: intrathecal morphine, Drug: Morphine PCAContinuous infiltration of local anesthetics + PCA morphine. |
| intrathecal morphine | Experimental | Drug: Morphine PCA, Drug: Ropivacaine infiltrationRachianalgesia + PCA morphine |
| morphine PCA | Active comparator | Drug: Morphine PCAPCA morphine alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Surgery of hepatic resection by first under costal.
- Patient classified ASA 1 to 3.
- Information, signed and informed consent
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intrathecal morphineA single intrathecal injection of 300 micrograms of Morphine preoperatively, just before induction. | Drug | Ropivacaine infiltration |
| Morphine PCAa postoperative Morphine PCA | Drug | Ropivacaine infiltration, intrathecal morphine, morphine PCA |
| Ropivacaine infiltrationRopivacaine 2mg / ml at the rate of 8ml per hour via a multiperforated catheter with connector after bolus of 20 ml | Drug | intrathecal morphine |
Primary outcome
Morphine Consumption
Time frame: During the first 24 hours post operative
Morphine consumption is measured all 3 hours during the first 24 hours post operative
20 secondary outcomes
Morphine Consumption
Time frame: During the 48 hours post operative
Evaluation of postoperative pain intensity at rest
Time frame: All 3 hours during the 48 postoperative hours
Evaluation of postoperative pain intensity after activity
Time frame: All 3 hours during the 48 postoperative hours
Electric nociception threshold measured by PainMatcher
Time frame: At the exit of Post Anesthesia Care Unit
Electric nociception threshold measured by PainMatcher
Time frame: At 24 hours post operative
Electric nociception threshold measured by PainMatcher
Time frame: At 48 hours post operative
Number of patient with a chronic pain after liver surgery, measured by Questionnaire Douleur de Saint-Antoine (QDSA)
Time frame: At 3 months after surgery
Number of patient with a chronic pain after liver surgery, measured by Questionnaire Douleur de Saint-Antoine (QDSA)
Time frame: At 6 months after surgery
Number of patient with a chronic pain after liver surgery, measured by Neuropathic Pain Symptom Inventory (NPSI)
Time frame: At 3 months after surgery
Number of patient with a chronic pain after liver surgery, measured by Neuropathic Pain Symptom Inventory (NPSI),
Time frame: At 6 months after surgery
Number of patient with a chronic pain after liver surgery, measured by Neuropathic pain diagnostic questionnaire (DN2),
Time frame: At 3 months after surgery
Number of patient with a chronic pain after liver surgery, measured by Neuropathic pain diagnostic questionnaire (DN2),
Time frame: At 6 months after surgery
Area peri-incisional hyperalgesia
Time frame: At 48 hours post operative
Number of nausea and/or vomiting episodes
Time frame: At 24 hours after surgery
Number of nausea and/or vomiting episodes
Time frame: At 48 hours after surgery
Number of nausea and/or vomiting episodes
Time frame: At 72 hours after surgery
Number of patient with side effect of morphine consumption
Time frame: Up to 72 hours after surgery
Time physiological function recovery
Time frame: Up to the end of hospital stay, an average 10 days
Length of hospital stay in intensive care unit
Time frame: Up to the end of hospital stay,an average 10 days
Length of hospital stay
Time frame: Up to the end of hospital stay , an average 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Results publication: PubMed 40662757Rousseleau 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilles Lebuffe, MD, PhD principal investigator
CHRU de Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing intrathecal morphine, Morphine PCA and Ropivacaine infiltration in people with Pain, Postoperative, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphine Consumption (time frame: During the first 24 hours post operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03238430, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.