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

Pain, Postoperative Clinical Trial

— CATHEPAT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03238430
• Other study ID #: 2013_48
• Secondary ID: 2014-003317-28
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: May 20, 2015
• Est. completion date: May 25, 2019

Study information

• Verified date: August 2020
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: May 25, 2019
• Est. primary completion date: May 25, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• intrathecal morphine
A single intrathecal injection of 300 micrograms of Morphine preoperatively, just before induction.
• Morphine PCA
a postoperative Morphine PCA
• Ropivacaine infiltration
Ropivacaine 2mg / ml at the rate of 8ml per hour via a multiperforated catheter with connector after bolus of 20 ml

Locations

Country	Name	City	State
France	CHRU , Hôpital Claude Huriez	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphine Consumption	Morphine consumption is measured all 3 hours during the first 24 hours post operative	During the first 24 hours post operative
Secondary	Morphine Consumption	Morphine consumption is measured all 3 hours during the 48 hours post operative	During the 48 hours post operative
Secondary	Evaluation of postoperative pain intensity at rest	The postoperative pain intensity is measured by Visual Analog Scale at rest	All 3 hours during the 48 postoperative hours
Secondary	Evaluation of postoperative pain intensity after activity	The postoperative pain intensity is measured by Visual Analog Scale after activity	All 3 hours during the 48 postoperative hours
Secondary	Electric nociception threshold measured by PainMatcher	The Electric nociception threshold is measured by PainMatcher (CefarCompex®)	At the exit of Post Anesthesia Care Unit
Secondary	Electric nociception threshold measured by PainMatcher	The Electric nociception threshold is measured by PainMatcher (CefarCompex®)	At 24 hours post operative
Secondary	Electric nociception threshold measured by PainMatcher	The Electric nociception threshold is measured by PainMatcher (CefarCompex®)	At 48 hours post operative
Secondary	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")	At 3 months after surgery
Secondary	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")	At 6 months after surgery
Secondary	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)	At 3 months after surgery
Secondary	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)	At 6 months after surgery
Secondary	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)	At 3 months after surgery
Secondary	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)	At 6 months after surgery
Secondary	Area peri-incisional hyperalgesia	The Surface of the cutaneous Area peri-incisional hyperalgesia is measured by Von frey's Filament.	At 48 hours post operative
Secondary	Number of nausea and/or vomiting episodes	Measured by collection of episodes of nausea and/or vomiting and consumption of anti-emetics	At 24 hours after surgery
Secondary	Number of nausea and/or vomiting episodes	Measured by collection of episodes of nausea and/or vomiting and consumption of anti-emetics	At 48 hours after surgery
Secondary	Number of nausea and/or vomiting episodes	Measured by collection of episodes of nausea and/or vomiting and consumption of anti-emetics	At 72 hours after surgery
Secondary	Number of patient with side effect of morphine consumption	Respiratory Depression, Urinary retention, Prurit	Up to 72 hours after surgery
Secondary	Time physiological function recovery	Nasogastric tube withdrawal time, Transit recovery, Ability to drink, to eat, to urinate, to walk	Up to the end of hospital stay, an average 10 days
Secondary	Length of hospital stay in intensive care unit		Up to the end of hospital stay,an average 10 days
Secondary	Length of hospital stay		Up to the end of hospital stay , an average 10 days