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

NCT ID: NCT02279628

Last Updated: 2014-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2017-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Postoperative Pain

Keywords

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cesarean section spinal anesthesia continuous wound infiltration intrathecal morphine oral morphine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Ropivacaine

Intervention Type DRUG

Ropivicaine (0.2%) bolus of 10ml will be injected through the catheter after surgery and continuously infused during the postoperative period (8ml/H)

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.

Group Type ACTIVE_COMPARATOR

Morphine

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

Ropivacaine

Intervention Type DRUG

Ropivicaine (0.2%) bolus of 10ml will be injected through the catheter after surgery and continuously infused during the postoperative period (8ml/H)

Morphine

Intervention Type DRUG

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

Interventions

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Ropivacaine

Ropivicaine (0.2%) bolus of 10ml will be injected through the catheter after surgery and continuously infused during the postoperative period (8ml/H)

Intervention Type DRUG

Morphine

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Maternite Regionale Universitaire

OTHER

Sponsor Role collaborator

Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hervé BOUAZIZ, MD., PhD.

Role: STUDY_CHAIR

Department of Anesthesiology, Maternité Régionale Universitaire, CHU NANCY, France

Florence VIAL, MD.

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology, Maternité Régionale Universitaire, CHU NANCY, France

Philippe GUERCI, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology and Critical Care Medicine, CHU NANCY Brabois, FRANCE

Locations

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Maternité Régionale Universitaire (MRU)

Nancy, Lorraine, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Florence VIAL, MD

Role: CONTACT

Phone: + 33 3 83 34 43 67

Email: [email protected]

Philippe GUERCI, MD

Role: CONTACT

Phone: +33 3 83 15 73 99

Email: [email protected]

Facility Contacts

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Florence VIAL, MD

Role: primary

Hervé BOUAZIZ, MD., PhD.

Role: backup

References

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Viviand C, Pietretti E, Luc A, Herbain D, Baka N, Morel O, Feugeas J, Aron C, Bouaziz H, Guerci P, Vial F. Continuous wound infusion combined with intrathecal morphine for analgesia after Cesarean delivery compared with intrathecal morphine or continuous wound infusion alone. Can J Anaesth. 2022 Jun;69(6):788-789. doi: 10.1007/s12630-022-02223-2. Epub 2022 Mar 10.

Reference Type DERIVED
PMID: 35274209 (View on PubMed)

Other Identifiers

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2012-004498-14

Identifier Type: -

Identifier Source: org_study_id