Transversus Abdominis Plane (TAP) Block Versus Intrathecal Morphine for Caesarean Section - Randomised Controlled Trial (MOTAP)
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
spinal anesthesia with intrathecal morphine
TAP-block with ropivacaine and clonidine
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain
Eligibility Criteria
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).
Sites / Locations
- Hôpitaux Universitaires de Genève
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
morphine group
TAP group
Arm Description
spinal anesthesia with intrathecal morphine
TAP-block with ropivacaine and clonidine
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Cumulative incidence of pruritus at 24h
inquired directly from the patient at 6 and 24h
Cumulative incidence of treated nausea and vomiting at 24h
(inquired directly from the patient at 6 and 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
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)
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)
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
Cumulative morphine consumption at 24 hours
(recorded in the memory of the patient controlled analgesia (PCA) pump).
Time until first PCA request
(recorded in the memory of the PCA pump
Pain score at rest at 6, 24 and 48 hours postoperatively
using the NRS scale (0-10)
Pain score on movement
at 24 and 48 hours postoperatively (using the numerical rating scale (NRS 0-10)).
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
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
Full Information
NCT ID
NCT01931215
First Posted
August 22, 2013
Last Updated
November 20, 2017
Sponsor
Benno Rehberg-Klug
Collaborators
Domitille Dereu
1. Study Identification
Unique Protocol Identification Number
NCT01931215
Brief Title
Transversus Abdominis Plane (TAP) Block Versus Intrathecal Morphine for Caesarean Section - Randomised Controlled Trial
Acronym
MOTAP
Official Title
Transversus Abdominis Plane (TAP) Block Versus Intrathecal Morphine for Caesarean Section - Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
September 2013 (Actual)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
August 28, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Benno Rehberg-Klug
Collaborators
Domitille Dereu
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
treatment versus placebo
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
pharmacy providing identical sets of study drugs and placebo, computerized random sequence generation, sequence held by the pharmacy until study completion
Allocation
Randomized
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
morphine group
Arm Type
Active Comparator
Arm Description
spinal anesthesia with intrathecal morphine
Arm Title
TAP group
Arm Type
Experimental
Arm Description
TAP-block with ropivacaine and clonidine
Intervention Type
Other
Intervention Name(s)
spinal anesthesia with intrathecal morphine
Intervention Description
in addition to the standard spinal anesthesia drugs (bupivacaine and fentanyl), morphine is added
Intervention Type
Other
Intervention Name(s)
TAP-block with ropivacaine and clonidine
Primary Outcome Measure Information:
Title
cumulative incidence of nausea and/or vomiting at 24 hours
Description
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 Outcome Measure Information:
Title
Cumulative incidence of pruritus at 24h
Description
inquired directly from the patient at 6 and 24h
Time Frame
24 h
Title
Cumulative incidence of treated nausea and vomiting at 24h
Description
(inquired directly from the patient at 6 and 24h).
Time Frame
24h
Title
Cumulative incidence of sedation at 6 and 24h.
Description
Sedation defined as an observer's assessment of alertness and sedation (OAAS) score lower than 4
Time Frame
24h
Title
Cumulative incidence of arterial hypotension
Description
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
Title
Cumulative incidence of bradycardia
Description
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
Title
Cumulative incidence of respiratory depression
Description
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
Title
Cumulative morphine consumption at 24 hours
Description
(recorded in the memory of the patient controlled analgesia (PCA) pump).
Time Frame
24h
Title
Time until first PCA request
Description
(recorded in the memory of the PCA pump
Time Frame
24h
Title
Pain score at rest at 6, 24 and 48 hours postoperatively
Description
using the NRS scale (0-10)
Time Frame
48h
Title
Pain score on movement
Description
at 24 and 48 hours postoperatively (using the numerical rating scale (NRS 0-10)).
Time Frame
48h
Title
Maternal satisfaction at 24 and 48 hours postoperatively
Description
measured on a numeric rating scale (at 6h) and with the questionnaire "quality of recovery" (QoR40) at 24 and 48h
Time Frame
48h
Title
persistent pain at 3 and 6 months postoperatively
Description
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Domitille Dereu, MD
Organizational Affiliation
HUG
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Domitille Dereu, MD
Organizational Affiliation
HUG
Official's Role
Study Director
Facility Information:
Facility Name
Hôpitaux Universitaires de Genève
City
Geneva
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
31274545
Citation
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.
Results Reference
derived
Learn more about this trial
Transversus Abdominis Plane (TAP) Block Versus Intrathecal Morphine for Caesarean Section - Randomised Controlled Trial
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