Postoperative PainPhase 4MOTAPNCT01931215
Transversus Abdominis Plane (TAP) Block Versus Intrathecal Morphine for Caesarean Section - Randomised Controlled Trial
A Phase 4 study testing spinal anesthesia with intrathecal morphine and TAP-block with ropivacaine and clonidine in people with Postoperative Pain, run by Benno Rehberg-Klug at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- spinal anesthesia with intrathecal morphine and TAP-block with ropivacaine and clonidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2013to 28 Aug 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Postoperative Pain
- Being tested
- spinal anesthesia with intrathecal morphine, TAP-block with ropivacaine and clonidine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spinal anesthesia with intrathecal morphineOther
in addition to the standard spinal anesthesia drugs (bupivacaine and fentanyl), morphine is added
TAP-block with ropivacaine and clonidineOther
| Study group | Role | What they receive |
|---|---|---|
| morphine group | Active comparator | spinal anesthesia with intrathecal morphine Receives: Other: spinal anesthesia with intrathecal morphine |
| TAP group | Experimental | TAP-block with ropivacaine and clonidine Receives: Other: TAP-block with ropivacaine and clonidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hours
Secondary outcomes (12)
Cumulative incidence of pruritus at 24h
inquired directly from the patient at 6 and 24h
Measured: 24 h
Cumulative incidence of treated nausea and vomiting at 24h
(inquired directly from the patient at 6 and 24h).
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 24h
Cumulative morphine consumption at 24 hours
(recorded in the memory of the patient controlled analgesia (PCA) pump).
Measured: 24h
Time until first PCA request
(recorded in the memory of the PCA pump
Measured: 24h
Pain score at rest at 6, 24 and 48 hours postoperatively
using the NRS scale (0-10)
Measured: 48h
Pain score on movement
at 24 and 48 hours postoperatively (using the numerical rating scale (NRS 0-10)).
Measured: 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
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2013 (estimated)
- Study startSep 2013
- Primary completionMar 2017
- Study completion28 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- treatment versus placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benno Rehberg-Klug
- Sponsor type
- University, hospital or other
- Collaborators
- Domitille Dereu
- Responsible party
- Sponsor-investigator, Benno Rehberg-Klug, University Hospital, Geneva
- Investigators
- Domitille Dereu, MD, Principal investigator, HUGDomitille Dereu, MD, Study director, HUG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01931215
- Sponsor's protocol ID
- MOTAP
- Other IDs
- CER 12-112
- Acronym
- MOTAP
- Status last verified
- Nov 2017
- First submitted
- 22 Aug 2013
- Last updated
- 21 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 31274545
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transversus Abdominis Plane (TAP) Block Versus Intrathecal Morphine for Caesarean Section - Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01931215
- Acronym / sponsor ID
- MOTAP / MOTAP
- Conditions
- Postoperative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Benno Rehberg-KlugUniversity, hospital or other
- Collaborators
- Domitille Dereu
- Study start
- Sep 2013 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- 28 Aug 2017 (actual)
- First posted
- 29 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- treatment versus placebo
| Arm | Type | Receives |
|---|---|---|
| morphine group | Active comparator | Other: spinal anesthesia with intrathecal morphinespinal anesthesia with intrathecal morphine |
| TAP group | Experimental | Other: TAP-block with ropivacaine and clonidineTAP-block with ropivacaine and clonidine |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spinal anesthesia with intrathecal morphinein addition to the standard spinal anesthesia drugs (bupivacaine and fentanyl), morphine is added | Other | morphine group |
| TAP-block with ropivacaine and clonidine | Other | TAP group |
Primary outcome
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
12 secondary outcomes
Cumulative incidence of pruritus at 24h
Time frame: 24 h
Cumulative incidence of treated nausea and vomiting at 24h
Time frame: 24h
Cumulative incidence of sedation at 6 and 24h.
Time frame: 24h
Cumulative incidence of arterial hypotension
Time frame: 24h
Cumulative incidence of bradycardia
Time frame: 24h
Cumulative incidence of respiratory depression
Time frame: 24h
Cumulative morphine consumption at 24 hours
Time frame: 24h
Time until first PCA request
Time frame: 24h
Pain score at rest at 6, 24 and 48 hours postoperatively
Time frame: 48h
Pain score on movement
Time frame: 48h
Maternal satisfaction at 24 and 48 hours postoperatively
Time frame: 48h
persistent pain at 3 and 6 months postoperatively
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2017.
- Derived from this study: PubMed 31274545Dereu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Domitille Dereu, MD principal investigator
HUG
Domitille Dereu, MD study director
HUG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing spinal anesthesia with intrathecal morphine and TAP-block with ropivacaine and clonidine in people with Postoperative Pain, run by Benno Rehberg-Klug at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cumulative incidence of nausea and/or vomiting at 24 hours (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01931215, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2017.