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

NCT02279628 | Unknown Phase 4

• 1 other identifier: 2012-004498-14
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Keywords

cesarean section; spinal anesthesia; continuous wound infiltration; intrathecal morphine; oral morphine

Outcome Measures

Primary Outcomes (1)

• Morphine consumption during the first 48 postoperative hours

  at the 48th hour

Secondary Outcomes (8)

• Pain at rest and at mobilization

  Every 4 hours during the first 48 postoperative hours

• Time to restoration of bowel function

  within the first 48 postoperative hours

• Verbal and Visual analog pain scores in the first standing position

  at day 1

• Number of patients that required oral morphine

  At the 24th and 48th hour

• Number of patients that required local anesthetic rescue dose through the catheter

  At the 24th and 48th hour

Study Arms (3)

Continuous wound infiltration alone

EXPERIMENTAL

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

Intrathecal moprhine alone

ACTIVE COMPARATOR

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

Intrathecal morphine&wound infiltration

EXPERIMENTAL

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; Drug: Morphine

Interventions

Ropivacaine DRUG

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

Continuous wound infiltration alone; Intrathecal morphine&wound infiltration

Morphine DRUG

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

Intrathecal moprhine alone; Intrathecal morphine&wound infiltration

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead
• Maternite Regionale Universitaire: collaborator

Study Sites (1)

Maternité Régionale Universitaire (MRU)

Nancy, Lorraine, 54000, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 35274209 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine; Morphine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Hervé BOUAZIZ, MD., PhD.

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

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Florence VIAL, MD

CONTACT

+ 33 3 83 34 43 67; f.vial@maternite.chu-nancy.fr

Philippe GUERCI, MD

CONTACT

+33 3 83 15 73 99; p.guerci@chu-nancy.fr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2014
• First Posted: October 31, 2014
• Study Start: July 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: June 1, 2017
• Last Updated: October 31, 2014

Record last verified: 2014-10

Locations

FR (1)