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

Phase 4CompletedNCT01931215

Benno Rehberg-Klug180 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

180

Conditions

Postoperative Pain

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

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

Time frame: 24 hours

Secondary Outcomes

Cumulative incidence of pruritus at 24h

inquired directly from the patient at 6 and 24h

Time frame: 24 h

Cumulative incidence of treated nausea and vomiting at 24h

(inquired directly from the patient at 6 and 24h).

Time frame: 24h

Cumulative incidence of sedation at 6 and 24h.

Sedation defined as an observer's assessment of alertness and sedation (OAAS) score lower than 4

Time frame: 24h

Cumulative incidence of arterial hypotension

defined as a systolic blood pressure of less than 100 mmHg for longer than 5 minutes (from nurse records at 6 and 24h)

Time frame: 24h

Cumulative incidence of bradycardia

defined as a heart rate of less than 50/min for longer than 5 minutes (from nurse records at 6 and 24h)

Time frame: 24h

Cumulative incidence of respiratory depression

defined as a respiratory frequency of less than 8/min for longer than 5 minutes (from nurse records at 6 and 24h

Time frame: 24h

Cumulative morphine consumption at 24 hours

(recorded in the memory of the patient controlled analgesia (PCA) pump).

Time frame: 24h

Time until first PCA request

(recorded in the memory of the PCA pump

Time frame: 24h

Pain score at rest at 6, 24 and 48 hours postoperatively

using the NRS scale (0-10)

Time frame: 48h

Pain score on movement

at 24 and 48 hours postoperatively (using the numerical rating scale (NRS 0-10)).

Time frame: 48h

Maternal satisfaction at 24 and 48 hours postoperatively

measured on a numeric rating scale (at 6h) and with the questionnaire "quality of recovery" (QoR40) at 24 and 48h

Time frame: 48h

persistent pain at 3 and 6 months postoperatively

Pain at rest, 0-10 pain scale; Pain on movement, 0-10 pain scale; Yes/no for scar pain;Yes/no for analgesic use

Time frame: 6 months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes