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Continuous Pre-uterine Wound Infiltration Versus Intrathecal Morphine for Postoperative Analgesia After Cesarean Section

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ClinicalTrials.gov Identifier: NCT02279628
Recruitment Status : Unknown
Verified October 2014 by Central Hospital, Nancy, France.
Recruitment status was:  Recruiting
First Posted : October 31, 2014
Last Update Posted : October 31, 2014
Sponsor:
Collaborator:
Maternite Regionale Universitaire
Information provided by (Responsible Party):
Central Hospital, Nancy, France

Brief Summary:
The cesarean section is considered as a painful surgery during the post operative period. Mothers may need to move immediately after the surgery to take care of their babies. This may increase the risk of major pain and chronic pain. Thus, excellent postoperative analgesia is required so that mothers do not experience pain in caring for their baby. Currently, several techniques have been developed to manage postoperative pain related to c-section scar such as intrathecal morphine during spinal anesthesia or continuous pre-peritoneal wound infiltration. The comparison between anesthetic techniques has never been performed and it is still not know if the combination of intrathecal morphine plus continuous pre-peritoneal wound infiltration provide a synergistic or additional effect on pain relief.

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Ropivacaine Drug: Morphine Phase 4

Detailed Description:
The aim of this study is to compare the efficacy of continuous wound infiltration versus intrathecal morphine for postoperative analgesia after scheduled cesarean section. The primary endpoint is morphine consumption during the first 48 postoperative hours.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Continuous Pre-uterine Wound Infiltration Versus Intrathecal Morphine for Postoperative Analgesia After Cesarean Section. Controlled Comparative Study.
Study Start Date : July 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Continuous wound infiltration alone
Spinal anesthesia will be performed with 10 mg bupivacain 0.5% hyperbaric, 3 μg sufentanil and 1 ml sodium chloride 0.9% (without morphine). Patient will then receive a continuous wound infiltration of ropivacaine 0.2% 8 ml/H via a preperitoneal catheter.
Drug: Ropivacaine
Ropivicaine (0.2%) bolus of 10ml will be injected through the catheter after surgery and continuously infused during the postoperative period (8ml/H)

Active Comparator: Intrathecal moprhine alone
Spinal anesthesia will be performed with 10 mg bupivacain 0.5% hyperbaric, 3 μg sufentanil and 0.1mg morphine. Patient will then receive a continuous wound infiltration of sodium chloride 0.9% 8 ml/H via a preperitoneal catheter.
Drug: Morphine
Morphine will be injected intrathecally (100µg) and oral morphine will be given during the postoperative period

Experimental: Intrathecal morphine&wound infiltration
Spinal anesthesia will be performed with 10 mg bupivacain 0.5% hyperbaric, 3 μg sufentanil and 0.1mg morphine. Patient will then receive a continuous wound infiltration of ropivacaine 0.2% 8 ml/H via a preperitoneal catheter.
Drug: Ropivacaine
Ropivicaine (0.2%) bolus of 10ml will be injected through the catheter after surgery and continuously infused during the postoperative period (8ml/H)

Drug: Morphine
Morphine will be injected intrathecally (100µg) and oral morphine will be given during the postoperative period




Primary Outcome Measures :
  1. Morphine consumption during the first 48 postoperative hours [ Time Frame: at the 48th hour ]

Secondary Outcome Measures :
  1. Pain at rest and at mobilization [ Time Frame: Every 4 hours during the first 48 postoperative hours ]
    The pain at rest and at mobilization will be evaluated with both Visual Analog scale and Verbal pain scale. The patient should describe the worst pain felt during the previous 4 hours in a lying position and at mobilization

  2. Time to restoration of bowel function [ Time Frame: within the first 48 postoperative hours ]
  3. Verbal and Visual analog pain scores in the first standing position [ Time Frame: at day 1 ]
  4. Number of patients that required oral morphine [ Time Frame: At the 24th and 48th hour ]
  5. Number of patients that required local anesthetic rescue dose through the catheter [ Time Frame: At the 24th and 48th hour ]
  6. Postoperative rehabilitation survey [ Time Frame: At the 48th hour ]
  7. Occurrence of side effect [ Time Frame: During the first 48 hours ]
    Itching, nausea and vomiting, drowsiness, urinary retention, hypoventilation, other will be assessed with a questionnaire

  8. Postoperative residual pain (DN4 survey) [ Time Frame: At 3 months postoperatively ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Elective Cesarean section
  • Spinal anesthesia
  • Singleton
  • ASA ( Physical status score) 1 to 3

Exclusion Criteria:

  • Age <18yrs
  • BMI ≥ 45 kg/m2 or weight < 45 kg
  • Refusal to consent
  • Urgent cesarean section
  • Allergy to a medication used in the protocol
  • Impaired hemostasis ou current infection
  • Contra indication or failure of spinal anesthesia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02279628


Contacts
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Contact: Florence VIAL, MD + 33 3 83 34 43 67 f.vial@maternite.chu-nancy.fr
Contact: Philippe GUERCI, MD +33 3 83 15 73 99 p.guerci@chu-nancy.fr

Locations
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France
Maternité Régionale Universitaire (MRU) Recruiting
Nancy, Lorraine, France, 54000
Contact: Florence VIAL, MD    +33 3 83 34 44 67    f.vial@maternite.chu-nancy.fr   
Contact: Hervé BOUAZIZ, MD., PhD.    +33 3 83 34 44 67    h.bouaziz@chu-nancy.fr   
Sponsors and Collaborators
Central Hospital, Nancy, France
Maternite Regionale Universitaire
Investigators
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Study Chair: Hervé BOUAZIZ, MD., PhD. Department of Anesthesiology, Maternité Régionale Universitaire, CHU NANCY, France
Principal Investigator: Florence VIAL, MD. Department of Anesthesiology, Maternité Régionale Universitaire, CHU NANCY, France
Principal Investigator: Philippe GUERCI, MD Department of Anesthesiology and Critical Care Medicine, CHU NANCY Brabois, FRANCE

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Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT02279628    
Other Study ID Numbers: 2012-004498-14
First Posted: October 31, 2014    Key Record Dates
Last Update Posted: October 31, 2014
Last Verified: October 2014
Keywords provided by Central Hospital, Nancy, France:
cesarean section
spinal anesthesia
continuous wound infiltration
intrathecal morphine
oral morphine
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Morphine
Ropivacaine
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Local