Transversus Abdominis Plane (TAP) Block Versus Intrathecal Morphine for Caesarean Section - Randomised Controlled Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- cumulative incidence of nausea and/or vomiting at 24 hours
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
pharmacy providing identical sets of study drugs and placebo, computerized random sequence generation, sequence held by the pharmacy until study completion
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
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).
Arms & Interventions
morphine group
spinal anesthesia with intrathecal morphine
Intervention: spinal anesthesia with intrathecal morphine (Other)
TAP group
TAP-block with ropivacaine and clonidine
Intervention: TAP-block with ropivacaine and clonidine (Other)
Outcomes
Primary Outcomes
cumulative incidence of nausea and/or vomiting at 24 hours
Time Frame: 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
Secondary Outcomes
- Cumulative incidence of treated nausea and vomiting at 24h(24h)
- Cumulative morphine consumption at 24 hours(24h)
- Pain score at rest at 6, 24 and 48 hours postoperatively(48h)
- Pain score on movement(48h)
- Maternal satisfaction at 24 and 48 hours postoperatively(48h)
- Cumulative incidence of sedation at 6 and 24h.(24h)
- Cumulative incidence of bradycardia(24h)
- Time until first PCA request(24h)
- Cumulative incidence of pruritus at 24h(24 h)
- Cumulative incidence of arterial hypotension(24h)
- Cumulative incidence of respiratory depression(24h)
- persistent pain at 3 and 6 months postoperatively(6 months)
Investigators
Benno Rehberg-Klug
Médecin adjoint agrégé
University Hospital, Geneva