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

Phase 4

Completed

• Conditions: Postoperative Pain
• Interventions: Other: TAP-block with ropivacaine and clonidine; Other: spinal anesthesia with intrathecal morphine

• Registration Number: NCT01931215
• Lead Sponsor: Benno Rehberg-Klug

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-08-22
• Study First Submitted QC: 2013-08-22
• Study First Posted: 2013-08-29
• Study Start: 2013-09
• Primary Completion: 2017-03
• Study Completion: 2017-08-28
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-20
• Last Update Posted: 2017-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 180

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAP group	TAP-block with ropivacaine and clonidine	TAP-block with ropivacaine and clonidine
morphine group	spinal anesthesia with intrathecal morphine	spinal anesthesia with intrathecal morphine

Primary Outcome Measures

Name	Time	Method
cumulative incidence of nausea and/or vomiting at 24 hours	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 Outcome Measures

Name	Time	Method
Pain score at rest at 6, 24 and 48 hours postoperatively	48h	using the NRS scale (0-10)
Cumulative incidence of treated nausea and vomiting at 24h	24h	(inquired directly from the patient at 6 and 24h).
Cumulative morphine consumption at 24 hours	24h	(recorded in the memory of the patient controlled analgesia (PCA) pump).
Pain score on movement	48h	at 24 and 48 hours postoperatively (using the numerical rating scale (NRS 0-10)).
Maternal satisfaction at 24 and 48 hours postoperatively	48h	measured on a numeric rating scale (at 6h) and with the questionnaire "quality of recovery" (QoR40) at 24 and 48h
Cumulative incidence of sedation at 6 and 24h.	24h	Sedation defined as an observer's assessment of alertness and sedation (OAAS) score lower than 4
Cumulative incidence of bradycardia	24h	defined as a heart rate of less than 50/min for longer than 5 minutes (from nurse records at 6 and 24h)
Time until first PCA request	24h	(recorded in the memory of the PCA pump
Cumulative incidence of pruritus at 24h	24 h	inquired directly from the patient at 6 and 24h
Cumulative incidence of arterial hypotension	24h	defined as a systolic blood pressure of less than 100 mmHg for longer than 5 minutes (from nurse records at 6 and 24h)
Cumulative incidence of respiratory depression	24h	defined as a respiratory frequency of less than 8/min for longer than 5 minutes (from nurse records at 6 and 24h
persistent pain at 3 and 6 months postoperatively	6 months	Pain at rest, 0-10 pain scale; Pain on movement, 0-10 pain scale; Yes/no for scar pain;Yes/no for analgesic use

Trial Locations

Locations (1)

Hôpitaux Universitaires de Genève; 🇨🇭 Geneva, Switzerland