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

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 Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Other: spinal anesthesia with intrathecal morphine; Other: TAP-block with ropivacaine and clonidine

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Phase 4

Contacts and Locations

Study Locations

• Switzerland
  • Geneva, Switzerland
    • Hôpitaux universitaires de Genève

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: morphine group; spinal anesthesia with intrathecal morphine	Other: spinal anesthesia with intrathecal morphine; in addition to the standard spinal anesthesia drugs (bupivacaine and fentanyl), morphine is added
Experimental: TAP group; TAP-block with ropivacaine and clonidine	Other: TAP-block with ropivacaine and clonidine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative incidence of pruritus at 24h	inquired directly from the patient at 6 and 24h	24 h
Cumulative incidence of treated nausea and vomiting at 24h	(inquired directly from the patient at 6 and 24h).	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	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)	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)	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	24h
Cumulative morphine consumption at 24 hours	(recorded in the memory of the patient controlled analgesia (PCA) pump).	24h
Time until first PCA request	(recorded in the memory of the PCA pump	24h
Pain score at rest at 6, 24 and 48 hours postoperatively	using the NRS scale (0-10)	48h
Pain score on movement	at 24 and 48 hours postoperatively (using the numerical rating scale (NRS 0-10)).	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	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	6 months

Collaborators and Investigators

• Sponsor: Benno Rehberg-Klug
• Collaborators: Domitille Dereu
• Investigators: Principal Investigator: Domitille Dereu, MD, HUG; Study Director: Domitille Dereu, MD, HUG

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2013
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): August 28, 2017

Study Registration Dates

• First Submitted: August 22, 2013
• First Submitted That Met QC Criteria: August 22, 2013
• First Posted (Estimate): August 29, 2013

Study Record Updates

• Last Update Posted (Actual): November 21, 2017
• Last Update Submitted That Met QC Criteria: November 20, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Anesthetics, Local; Sympatholytics; Ropivacaine; Morphine; Clonidine
• Other Study ID Numbers: MOTAP; CER 12-112 (Other Identifier: Comité d'éthique de la recherche des HUG)