Postoperative PainPhase 4NCT01261637
Abdominal Wall Local Anesthesia to Maximize Postoperative Pain Control After Cesarean Delivery
A Phase 4 study testing Ropivicaine in people with Postoperative Pain, run by IWK Health Centre at 1 site in Canada.
Trial summary
This study has been designed to determine if women undergoing cesarean delivery with spinal anesthesia and routine pain management who also have an additional ultrasound guided transversus abdominis plane (TAP)block using ropivacaine have better pain relief and a better quality of recovery than women who don't have… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Ropivicaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2009to Jan 2011
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Non-emergent CD with planned spinal anesthesia
- American Society of Anesthesia physical status class I \& II
- Age ≥ 18 years
- Term gestational age (≥ 37 weeks)
- English-speaking
Who cannot join
- Morbid Obesity (BMI³ 45 kg/m2)
- Laboring women
- Emergency CD
- Severe maternal cardiac disease
- Subjects with significant obstetric co-morbidities
- Failed spinal anesthesia
Show all 10Show fewer
- Patient enrollment in another study involving medication within 30 days of CD
- Any other condition which may impair ability to cooperate with data collection
- Height less than 152 cm (5'0")
- Fetal anomalies or intrauterine fetal death
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Guided 0.25% Ropivacaine Transversus Abdominis Plane Block in Addition to Intrathecal Morphine and Multimodal Analgesia for the Management of Postoperative Pain Among Women Undergoing Cesarean Delivery.
This study has been designed to determine if women undergoing cesarean delivery with spinal anesthesia and routine pain management who also have an additional ultrasound guided transversus abdominis plane (TAP)block using ropivacaine have better pain relief and a better quality of recovery than women who don't have the additional TAP block. Maximizing pain relief using ultrasound guided TAP blocks in addition to neuraxial opioids, NSAIDs, and acetaminophen may improve acute pain outcomes, reduce adverse side effects, and potentially reduce chronic pain.
- Conditions
- Postoperative Pain
- Being tested
- Saline placebo, Ropivicaine
- Keywords
- cesarean, pain, transversus abdominus plane block
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saline placeboDrug
20ml saline
RopivicaineDrug
Also called Naropin
0.25% ropivicaine (maximum 1.5mg/kg)
| Study group | Role | What they receive |
|---|---|---|
| 0.25% Ropivicaine | Experimental | 0.25% ropivicaine (maximum 1.5mg/kg) Receives: Drug: Ropivicaine |
| Placebo | Placebo comparator | 20ml saline Receives: Drug: Saline placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome will be postoperative pain, measured by an NRS, the quality of recovery score (QoR) and a Self Assessment Diary in the first 24h postoperative period.
Measured: 24 hours
Secondary outcomes (3)
NRS / QoR - 48 hour Opioid Consumption Side effects - nausea, sedation
Measured: 48 hours
TAP block success rates and duration of block effect will be assessed using a patient diary completed every 2 hours while the patient is awake.
Measured: 24 hours
Persistant pain outcomes will be assessed at 30 days and 6 months using 5-minute SF-36 health survey.
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 posted16 Dec 2010 (estimated)
- Study startJul 2009
- Primary completionJul 2010
- Study completionJan 2011
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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- IWK Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ronald George, IWK Health Centre
- Investigators
- Dolores McKeen, MD MSc FRCPC, Principal investigator, IWK Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01261637
- Sponsor's protocol ID
- IWK-4518-2009
- Other IDs
- IWK REB 4518
- Status last verified
- May 2013
- First submitted
- 15 Dec 2010
- Last updated
- 23 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
McKeen DM, George RB, Boyd JC, Allen VM, Pink A. Transversus abdominis plane block does not improve early or late pain outcomes after Cesarean delivery: a randomized controlled trial. Can J Anaesth. 2014 Jul;61(7):631-40. doi: 10.1007/s12630-014-0162-5. Epub 2014 Apr 24.
PubMed 24764186
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided 0.25% Ropivacaine Transversus Abdominis Plane Block in Addition to Intrathecal Morphine and Multimodal Analgesia for the Management of Postoperative Pain Among Women Undergoing Cesarean Delivery.
- ClinicalTrials.gov ID
- NCT01261637
- Acronym / sponsor ID
- IWK-4518-2009
- Conditions
- Postoperative Pain
- Keywords
- cesarean, pain, transversus abdominus plane block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- IWK Health CentreUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 16 Dec 2010 (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.
This study has been designed to determine if women undergoing cesarean delivery with spinal anesthesia and routine pain management who also have an additional ultrasound guided transversus abdominis plane (TAP)block using ropivacaine have better pain relief and a better quality of recovery than women who don't have the additional TAP block. Maximizing pain relief using ultrasound guided TAP blocks in addition to neuraxial opioids, NSAIDs, and acetaminophen may improve acute pain outcomes, reduce adverse side effects, and potentially reduce chronic pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.25% Ropivicaine | Experimental | Drug: Ropivicaine0.25% ropivicaine (maximum 1.5mg/kg) |
| Placebo | Placebo comparator | Drug: Saline placebo20ml saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Non-emergent CD with planned spinal anesthesia
- American Society of Anesthesia physical status class I \& II
- Age ≥ 18 years
- Term gestational age (≥ 37 weeks)
- English-speaking
Key exclusion criteria (10 listed)
- Morbid Obesity (BMI³ 45 kg/m2)
- Laboring women
- Emergency CD
- Severe maternal cardiac disease
- Subjects with significant obstetric co-morbidities
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 |
|---|---|---|
| Saline placebo20ml saline | Drug | Placebo |
| RopivicaineAlso: Naropin0.25% ropivicaine (maximum 1.5mg/kg) | Drug | 0.25% Ropivicaine |
Primary outcome
The primary outcome will be postoperative pain, measured by an NRS, the quality of recovery score (QoR) and a Self Assessment Diary in the first 24h postoperative period.
Time frame: 24 hours
3 secondary outcomes
NRS / QoR - 48 hour Opioid Consumption Side effects - nausea, sedation
Time frame: 48 hours
TAP block success rates and duration of block effect will be assessed using a patient diary completed every 2 hours while the patient is awake.
Time frame: 24 hours
Persistant pain outcomes will be assessed at 30 days and 6 months using 5-minute SF-36 health survey.
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 23 May 2013.
- Derived from this study: PubMed 24764186McKeen DM, George RB, Boyd JC, Allen VM, Pink A. Transversus abdominis plane block does not improve early or late pain outcomes after Cesarean delivery: a randomized controlled trial. Can J Anaesth. 2014 Jul;61(7):631-40. doi: 10.1007/s12630-014-0162-5. Epub 2014 Apr 24.
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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.
Dolores McKeen, MD MSc FRCPC principal investigator
IWK Health Centre
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 Ropivicaine in people with Postoperative Pain, run by IWK Health Centre at 1 site in Canada.
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 5 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 23 May 2013. 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 Canada. 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. Some participants in this study may receive a placebo. 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?
The primary outcome will be postoperative pain, measured by an NRS, the quality of recovery score (QoR) and a Self Assessment Diary in the first 24h postoperative period. (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 NCT01261637, 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 23 May 2013; AzTrials last refreshed its copy on 6 Nov 2026.