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

Central Hospital, Nancy, France

Status and phase: Unknown; Phase 4

Conditions: Postoperative Pain

Treatments: Drug: Ropivacaine; Drug: Morphine

Study type: Interventional

Funder types: Other

Identifiers

NCT02279628

2012-004498-14

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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150 participants in 3 patient groups

Continuous wound infiltration alone

Experimental group

Description:

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.

Treatment:

Drug: Ropivacaine

Intrathecal moprhine alone

Active Comparator group

Description:

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.

Treatment:

Drug: Morphine

Intrathecal morphine&wound infiltration

Experimental group

Description:

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.

Treatment:

Drug: Ropivacaine

Drug: Morphine