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

Phase 2

Completed

• Conditions: Pain, Postoperative
• Interventions: Drug: intrathecal morphine; Drug: Morphine PCA; Drug: Ropivacaine infiltration

• Registration Number: NCT03238430
• Lead Sponsor: University Hospital, Lille

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-20
• Study First Submitted: 2017-07-31
• Study First Submitted QC: 2017-07-31
• Study First Posted: 2017-08-03
• Primary Completion: 2019-05-25
• Study Completion: 2019-05-25
• Status Verified: 2020-08
• Last Update Submitted: 2022-10-13
• Last Update Posted: 2022-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 186

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ropivacaine infiltration	intrathecal morphine	Continuous infiltration of local anesthetics + PCA morphine.
Ropivacaine infiltration	Morphine PCA	Continuous infiltration of local anesthetics + PCA morphine.
intrathecal morphine	Morphine PCA	Rachianalgesia + PCA morphine
intrathecal morphine	Ropivacaine infiltration	Rachianalgesia + PCA morphine
morphine PCA	Morphine PCA	PCA morphine alone

Primary Outcome Measures

Name	Time	Method
Morphine Consumption	During the first 24 hours post operative	Morphine consumption is measured all 3 hours during the first 24 hours post operative

Secondary Outcome Measures

Name	Time	Method
Morphine Consumption	During the 48 hours post operative	Morphine consumption is measured all 3 hours during the 48 hours post operative
Evaluation of postoperative pain intensity after activity	All 3 hours during the 48 postoperative hours	The postoperative pain intensity is measured by Visual Analog Scale after activity
Electric nociception threshold measured by PainMatcher	At 48 hours post operative	The Electric nociception threshold is measured by PainMatcher (CefarCompex®)
Evaluation of postoperative pain intensity at rest	All 3 hours during the 48 postoperative hours	The postoperative pain intensity is measured by Visual Analog Scale at rest
Number of patient with a chronic pain after liver surgery, measured by Questionnaire Douleur de Saint-Antoine (QDSA)	At 6 months after surgery	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)	At 3 months after surgery	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),	At 6 months after surgery	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),	At 6 months after surgery	Evaluation with validated score for chronic and neuropathic pains (DN2)
Area peri-incisional hyperalgesia	At 48 hours post operative	The Surface of the cutaneous Area peri-incisional hyperalgesia is measured by Von frey's Filament.
Number of nausea and/or vomiting episodes	At 72 hours after surgery	Measured by collection of episodes of nausea and/or vomiting and consumption of anti-emetics
Number of patient with side effect of morphine consumption	Up to 72 hours after surgery	Respiratory Depression, Urinary retention, Prurit
Time physiological function recovery	Up to the end of hospital stay, an average 10 days	Nasogastric tube withdrawal time, Transit recovery, Ability to drink, to eat, to urinate, to walk
Length of hospital stay in intensive care unit	Up to the end of hospital stay,an average 10 days
Length of hospital stay	Up to the end of hospital stay , an average 10 days

Trial Locations

Locations (1)

CHRU , Hôpital Claude Huriez; 🇫🇷 Lille, France