Clinical trial NCT01931215: Transversus Abdominis Plane (TAP) Block Versus Intrathecal Morphine for Caesarean Section - Randomised Controlled Trial
Official title: Transversus Abdominis Plane (TAP) Block Versus Intrathecal Morphine for Caesarean Section - Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
Collaborators: name: Domitille Dereu
First posted: 2013-08-29
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: treatment versus placebo
Primary purpose: TREATMENT

Brief summary: Analgesia after cesarean section is still not satisfactory for many women. Even if pain reduction is sufficient with the technique of intrathecal morphine injection, side effects such as nausea and pruritus are common.

Since several years, an alternative technique has been studied, the "transversus abdominis plane (TAP)"-block. Here a local anesthetic is injected in the abdominal wall muscles, and this has been shown to give a similar analgesic effect compared to intrathecal morphine, with potentially less side effects.

With this study, we want to evaluate if the TAP-block yields indeed less side effects when compared with intrathecal morphine.

The study will be a prospective study with the patients randomized to either a group with intrathecal morphine or a group with TAP-block.


Eligibility criteria: Inclusion Criteria:

Subjects must satisfy all of the following criteria to be enrolled into the study:

* American Society of Anesthesiology (ASA) physical status less than 3 Able to read and understand the information sheet and to sign and date the consent form
* Scheduled for elective C-section planned with spinal anaesthesia
* Age\>18

Exclusion Criteria:

Potential subjects who meet any of the following criteria will be excluded from participating in the study:

* Complicated pregnancy defined as having preeclampsia or placenta accreta, increta and percreta.
* Drug addiction.
* Contraindication to spinal anaesthesia (history of clotting disorders, septicemia, local infection at the injection site, spinal malformation, elevated intracranial pressure)
* Contraindication to TAP block (skin infection, abdominal wall muscle defect such as hernia and previous abdominal wall mesh).
* BMI\>40 kg/m2
* Weight less than 50 kg the day of the C-section.
* Height less than 150 cm or more than 175 cm.
* Allergy/contraindication to any medication used in the study.
* Previous median abdominal incision. Necessity to perform the C-section urgently before the scheduled date (with less than 24h preparation time).

Primary outcomes:
measure: cumulative incidence of nausea and/or vomiting at 24 hours
timeFrame: 24 hours
Secondary outcomes:
measure: Cumulative incidence of pruritus at 24h
timeFrame: 24 h
measure: Cumulative incidence of treated nausea and vomiting at 24h
timeFrame: 24h
measure: Cumulative incidence of sedation at 6 and 24h.
timeFrame: 24h
measure: Cumulative incidence of arterial hypotension
timeFrame: 24h
measure: Cumulative incidence of bradycardia
timeFrame: 24h
measure: Cumulative incidence of respiratory depression
timeFrame: 24h
measure: Cumulative morphine consumption at 24 hours
timeFrame: 24h
measure: Time until first PCA request
timeFrame: 24h
measure: Pain score at rest at 6, 24 and 48 hours postoperatively
timeFrame: 48h
measure: Pain score on movement
timeFrame: 48h
measure: Maternal satisfaction at 24 and 48 hours postoperatively
timeFrame: 48h
measure: persistent pain at 3 and 6 months postoperatively
timeFrame: 6 months
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Hôpitaux Universitaires de Genève
Study officials:
affiliation: HUG
name: Domitille Dereu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: HUG
name: Domitille Dereu, MD
role: STUDY_DIRECTOR
References:
citation: Dereu D, Savoldelli GL, Mercier Y, Combescure C, Mathivon S, Rehberg B. The impact of a transversus abdominis plane block including clonidine vs. intrathecal morphine on nausea and vomiting after caesarean section: A randomised controlled trial. Eur J Anaesthesiol. 2019 Aug;36(8):575-582. doi: 10.1097/EJA.0000000000001013.