Postoperative PainPhase 4TAP-CATNCT03102515
Transversus Abdominis Plane Block vs Continuous Infiltration Wound Catheter for Analgesia After Caesarean Section
A Phase 4 study testing USG-TAP block and CIC in people with Postoperative Pain, run by University Hospital, Caen.
Trial summary
Analgesia following surgery associates different intra-venous or oral analgesic drugs and sometimes opioids. To reduce opioid consumption, loco-regional anaesthesia might be administered as a complement. 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?
- USG-TAP block and CIC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- No sites listed yet
- Study dates
- 29 May 2016to 26 Oct 2016
- 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
- Informed consent,
- Age>/=18 years,
- Caesarean section under spinal or epidural anaesthesia
- Technique surgical "Cohen Stark méthod".
Who cannot join
- Patient refusal,
- Patient under guardianship,
- Contraindication to one of the two techniques,
- Cesarean section under general anesthesia
- Allergies to local anesthetics
- Maternal instability
About this study
Official title: Transversus Abdominis Plane Block vs Continuous Infiltration Wound Catheter for Analgesia After Caesarean Section: a Randomized Trial. (TAP-CAT Study)
Analgesia following surgery associates different intra-venous or oral analgesic drugs and sometimes opioids. To reduce opioid consumption, loco-regional anaesthesia might be administered as a complement. In the specific context of caesarean sections, pain control is mandatory to enable the mother to take care of her offspring and shorten their hospital stay. This intervention is mainly performed under neuraxial anaesthesia (spinal or epidural), enabling the injection of morphine in the subdural or epidural space, as part of a multimodal analgesia regimen.
Studies have evaluated continuous wound infiltration catheters (CIC) and ultrasound-guided (UGD) transabdominis plane (TAP) block, and both techniques and both techniques reduce postoperative morphine consumption. Recent studies have compared the two techniques and found conflicting results. Furthermore, they did not consider caesarean section performed under epidural analgesia, with a different neuraxial injection site, neither did they compared pain after postoperative day 2.
Consequently, the aim of this study was to compare resting and standing pain up to postoperative day 3 after caesarean section performed under spinal or epidural anaesthesia and receiving either USG-TAP block or CIC. Baseline hypothesis was that the continuous infiltration provided a better analgesia at day 2.
- Conditions
- Postoperative Pain
- Being tested
- USG-TAP block, CIC
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
USG-TAP blockDrug
CICDrug
| Study group | Role | What they receive |
|---|---|---|
| Spinal-anesthesia | Other | Caesarean section performed under spinal anaesthesia and receiving either USG-TAP block or CIC Receives: Drug: USG-TAP block; Drug: CIC |
| Epidural-anesthesia | Other | Caesarean section performed under epidural anaesthesia and receiving either USG-TAP block or CIC Receives: Drug: USG-TAP block; Drug: CIC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative standing pain at day 2
Assessment of Pain on Mobilization by a Numeric Scale of Pain
Measured: Evaluate standing pain at 48 hours postoperatively
Secondary outcomes (5)
standing and resting pain measured during the first 3 days
Assessment of Pain by a Numeric Scale of Pain
Measured: Evaluate pain at during 3 days postoperatively
Cumulative dose of Tramadol during the first 3 days
Measured: during the first 3 days
Cumulative dose of nefopam during the first 3 days
Measured: during the first 3 days
Cumulative dose of oxycodone during the first 3 days
Measured: during the first 3 days
patient comfort assessed daily by visual analogic scale
by visual analogic scale
Measured: during the first 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2017
- Study start29 May 2016
- Primary completion26 Oct 2016
- Study completion26 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Sequential
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03102515
- Sponsor's protocol ID
- 2016-A00131-50
- Acronym
- TAP-CAT
- Status last verified
- Mar 2017
- First submitted
- 31 Mar 2017
- Last updated
- 1 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transversus Abdominis Plane Block vs Continuous Infiltration Wound Catheter for Analgesia After Caesarean Section: a Randomized Trial. (TAP-CAT Study)
- ClinicalTrials.gov ID
- NCT03102515
- Acronym / sponsor ID
- TAP-CAT / 2016-A00131-50
- Conditions
- Postoperative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 29 May 2016 (actual)
- Primary completion
- 26 Oct 2016 (actual)
- Study completion
- 26 Oct 2016 (actual)
- First posted
- 5 Apr 2017 (actual)
- 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 following surgery associates different intra-venous or oral analgesic drugs and sometimes opioids. To reduce opioid consumption, loco-regional anaesthesia might be administered as a complement. In the specific context of caesarean sections, pain control is mandatory to enable the mother to take care of her offspring and shorten their hospital stay. This intervention is mainly performed under neuraxial anaesthesia (spinal or epidural), enabling the injection of morphine in the subdural or epidural space, as part of a multimodal analgesia regimen.
Studies have evaluated continuous wound infiltration catheters (CIC) and ultrasound-guided (UGD) transabdominis plane (TAP) block, and both techniques and both techniques reduce postoperative morphine consumption. Recent studies have compared the two techniques and found conflicting results. Furthermore, they did not consider caesarean section performed under epidural analgesia, with a different neuraxial injection site, neither did they compared pain after postoperative day 2.
Consequently, the aim of this study was to compare resting and standing pain up to postoperative day 3 after caesarean section performed under spinal or epidural anaesthesia and receiving either USG-TAP block or CIC. Baseline hypothesis was that the continuous infiltration provided a better analgesia at day 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal-anesthesia | Other | Drug: USG-TAP block, Drug: CICCaesarean section performed under spinal anaesthesia and receiving either USG-TAP block or CIC |
| Epidural-anesthesia | Other | Drug: USG-TAP block, Drug: CICCaesarean section performed under epidural anaesthesia and receiving either USG-TAP block or CIC |
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)
- Informed consent,
- Age>/=18 years,
- Caesarean section under spinal or epidural anaesthesia
- Technique surgical "Cohen Stark méthod".
Key exclusion criteria (6 listed)
- Patient refusal,
- Patient under guardianship,
- Contraindication to one of the two techniques,
- Cesarean section under general anesthesia
- Allergies to local anesthetics
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 |
|---|---|---|
| USG-TAP block | Drug | Epidural-anesthesia, Spinal-anesthesia |
| CIC | Drug | Epidural-anesthesia, Spinal-anesthesia |
Primary outcome
Postoperative standing pain at day 2
Time frame: Evaluate standing pain at 48 hours postoperatively
Assessment of Pain on Mobilization by a Numeric Scale of Pain
5 secondary outcomes
standing and resting pain measured during the first 3 days
Time frame: Evaluate pain at during 3 days postoperatively
Cumulative dose of Tramadol during the first 3 days
Time frame: during the first 3 days
Cumulative dose of nefopam during the first 3 days
Time frame: during the first 3 days
Cumulative dose of oxycodone during the first 3 days
Time frame: during the first 3 days
patient comfort assessed daily by visual analogic scale
Time frame: during the first 3 days
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 1 Sep 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing USG-TAP block and CIC in people with Postoperative Pain, run by University Hospital, Caen.
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 6 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 1 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Postoperative standing pain at day 2 (time frame: Evaluate standing pain at 48 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Sep 2020.