Comparison of Two Types of Pain Relief After Cesarean Delivery

Phase 4TerminatedNCT01151943

Hopital Foch77 enrolled

Overview

Women undergoing elective cesarean delivery, performed under a standard spinal anesthesia, will be randomized to undergo either TAP block or incisional infiltration with local anesthetic, in addition to standard postoperative analgesia comprising regular acetaminophen, nefopam and ketoprofen. Short acting oral morphine will be given as a rescue treatment in case of severe pain.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cesarean Section

Interventions

Transversus Abdominis Plane (TAP) BlockOTHER

Bilateral injection of levobupivacaine (20 mL, 3.75 mg/mL)

Incisional Infiltration of Local AnestheticOTHER

continuous administration of levobupivacaine (1,25 mg/mL,5 mL/h) during 48 hours.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * scheduled cesarean section performed under spinal anesthesia * ASA I or II * height above 1,55 m * singleton pregnancy Exclusion Criteria: * contre indication to a drug used in the study (levobupivacaine, ketoprofen, nefopam)

Locations (1)

Hôpital Foch

Suresnes, France

Outcomes

Primary Outcomes

severity of postoperative pain

Time frame: 48 postoperative hours

Secondary Outcomes

delay before the first rescue dose of morphine

Time frame: 48 postoperative hours

morphine requirement

Time frame: 48 postoperative hours

complication of each loco-regional technique

Time frame: end of hospitalisation

patient's satisfaction

Time frame: end of hospitalisation

length of hospital stay

Time frame: end of hospitalisation

occurrence of a neuropathic postoperative pain

Time frame: 1 month postoperatively

Data from ClinicalTrials.gov

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