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

NCT01931215 | Completed Phase 4

• 2 other identifiers: MOTAPCER 12-112
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• cumulative incidence of nausea and/or vomiting at 24 hours

  Data for this endpoint will be gathered at 6h and 24h postoperatively from nurses' records in the recovery room (at 6h) and on the ward (at 24h), and counterchecked by asking the patient

  24 hours

Secondary Outcomes (12)

• Cumulative incidence of pruritus at 24h

  24 h

• Cumulative incidence of treated nausea and vomiting at 24h

  24h

• Cumulative incidence of sedation at 6 and 24h.

  24h

• Cumulative incidence of arterial hypotension

  24h

• Cumulative incidence of bradycardia

  24h

Study Arms (2)

morphine group

ACTIVE COMPARATOR

spinal anesthesia with intrathecal morphine

Other: spinal anesthesia with intrathecal morphine

TAP group

EXPERIMENTAL

TAP-block with ropivacaine and clonidine

Other: TAP-block with ropivacaine and clonidine

Interventions

spinal anesthesia with intrathecal morphine OTHER

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

morphine group

TAP-block with ropivacaine and clonidine OTHER

TAP group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Benno Rehberg-Klug: lead
• Domitille Dereu: collaborator

Study Sites (1)

Hôpitaux Universitaires de Genève

Geneva, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 31274545 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Anesthesia, Spinal; Ropivacaine; Clonidine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Domitille Dereu, MD

  HUG

  PRINCIPAL INVESTIGATOR

• Domitille Dereu, MD

  HUG

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: pharmacy providing identical sets of study drugs and placebo, computerized random sequence generation, sequence held by the pharmacy until study completion
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Médecin adjoint agrégé

Model Details: treatment versus placebo

Study Record Dates

• First Submitted: August 22, 2013
• First Posted: August 29, 2013
• Study Start: September 1, 2013
• Primary Completion: March 1, 2017
• Study Completion: August 28, 2017
• Last Updated: November 21, 2017

Record last verified: 2017-11

Locations

CH (1)