Transversus Abdominis Plane (TAP) Block Versus Intrathecal Morphine for Caesarean Section - Randomised Controlled Trial

NCT ID: NCT01931215

Last Updated: 2017-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2017-08-28

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.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

morphine group

spinal anesthesia with intrathecal morphine

Group Type: ACTIVE_COMPARATOR

spinal anesthesia with intrathecal morphine

Intervention Type: OTHER

in addition to the standard spinal anesthesia drugs (bupivacaine and fentanyl), morphine is added

TAP group

TAP-block with ropivacaine and clonidine

Group Type: EXPERIMENTAL

TAP-block with ropivacaine and clonidine

Intervention Type: OTHER

Interventions

spinal anesthesia with intrathecal morphine

in addition to the standard spinal anesthesia drugs (bupivacaine and fentanyl), morphine is added

Intervention Type: OTHER

TAP-block with ropivacaine and clonidine

Intervention Type: OTHER

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Domitille Dereu

UNKNOWN

Sponsor Role: collaborator

Benno Rehberg-Klug

OTHER

Sponsor Role: lead

Responsible Party

Benno Rehberg-Klug

Médecin adjoint agrégé

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Domitille Dereu, MD

Role: PRINCIPAL_INVESTIGATOR

HUG

Domitille Dereu, MD

Role: STUDY_DIRECTOR

HUG

Locations

Hôpitaux Universitaires de Genève

Geneva, , Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 31274545 (View on PubMed)

Other Identifiers

CER 12-112

Identifier Type: OTHER

Identifier Source: secondary_id

MOTAP

Identifier Type: -

Identifier Source: org_study_id