Comparison of Two Types of Pain Relief After Cesarean Delivery

NCT ID: NCT01151943

Last Updated: 2016-11-03

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

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2012-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cesarean Section

Keywords

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cesarean section continuous wound infiltration transversus abdominis plane block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Transversus Abdominis Plane (TAP) Block

Patients will receive a bilateral transversus abdominis plane block

Group Type EXPERIMENTAL

Transversus Abdominis Plane (TAP) Block

Intervention Type OTHER

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

Incisional Infiltration of Local Anesthetic

Patients will receive an incisional infiltration with local anesthetic (continuous administration of levobupivacaïne during 48 hours)

Group Type ACTIVE_COMPARATOR

Incisional Infiltration of Local Anesthetic

Intervention Type OTHER

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

Interventions

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Transversus Abdominis Plane (TAP) Block

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

Intervention Type OTHER

Incisional Infiltration of Local Anesthetic

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

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hopital Foch

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marc Fischler, MD

Role: STUDY_CHAIR

Hôpital Foch

Locations

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Hôpital Foch

Suresnes, , France

Site Status

Countries

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France

References

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Chandon M, Bonnet A, Burg Y, Barnichon C, DesMesnards-Smaja V, Sitbon B, Foiret C, Dreyfus JF, Rahmani J, Laloe PA, Fischler M, Le Guen M. Ultrasound-guided Transversus Abdominis plane block versus continuous wound infusion for post-caesarean analgesia: a randomized trial. PLoS One. 2014 Aug 5;9(8):e103971. doi: 10.1371/journal.pone.0103971. eCollection 2014.

Reference Type DERIVED
PMID: 25093663 (View on PubMed)

Other Identifiers

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2010-019662-88

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2010/15

Identifier Type: -

Identifier Source: org_study_id