Pain ControlNCT00945620
Trans-Abdominis Plane Block Efficacy for Post-Cesarean Section Pain
A study testing ropivicaine in people with Pain Control, run by Vanderbilt University at 1 site in United States.
Trial summary
The primary aim of this study is to measure the magnitude and duration of trans-abdominis plane (TAP) block analgesia in parturients undergoing elective cesarean section with concurrent standard of care operative analgesic regimens including intrathecal morphine sulfate (ITMS). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Pain Control
- What is being tested?
- ropivicaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Sep 2013
- Phase
- Interventional
- 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 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Singleton pregnancy
- Pre-pregnancy body mass index less than or equal to 35
- Elective repeat cesarean section under SAB or CSE (patients in whom the epidural catheter is activated intra-operatively will be excluded)
- English-Speaking patient
- Age at least 18 and no more than 40 years old.
Who cannot join
- Chronic pain or daily consumption of pain medications
- Neurologic disorders producing altered sensory perception or impaired motor strength in lower extremities or abdomen
- Pre-existing epidural analgesia infusion for labor analgesia.
- Spinal anesthetic failure requiring epidural catheter use or general anesthesia
- Intra-operative conversion to general anesthesia for fetal indications.
- Cesarean section performed with a vertical (not Phannenstiel) incision
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Trans-Abdominis Plane Block Efficacy for Post-Cesarean Section Pain: A Randomized Double-Blinded Case Control Trial
The primary aim of this study is to measure the magnitude and duration of trans-abdominis plane (TAP) block analgesia in parturients undergoing elective cesarean section with concurrent standard of care operative analgesic regimens including intrathecal morphine sulfate (ITMS). A one sided block model takes advantage of the bilateral nature of the pain created by a bilateral surgical wound and allows each patient to serve as her own control. Reduced variability allows a more definitive establishment of analgesic benefit for this block.
The current reports of conflicting data regarding efficacy make uncertain the role of TAP block in post cesarean section pain relief. This model would have a better potential for measuring the block's effectiveness. Quantitative sensory evaluation tools such as the von Frey hair tool provides a quantitative reproducible measure of skin sensation and also allows for assessment of block regression over time. Pressure algometry has been established as a clinical and research tool for quantitative assessment of pain levels in multiple pain conditions. A useful inexpensive reliable pressure algometer has recently been described.
Read more
The assessment of serum ropivicaine levels with this block will provide useful data regarding the systemic absorption of local anesthetic compared to other peripheral nerve blocks and establish the safety of the technique.
In addition this study will help establish a model for the study of TAP block modifications in the future. If block effectiveness is demonstrated, this model can be used to examine numerous block parameters including choice of local anesthetic and dose response analysis for optimal volume and concentration. Potential future study may be done also in the area of adjuncts found to have increased duration and effectiveness as used in other peripheral nerve blocks.
Expected duration of this study is 18 months.
Read the detailed description
This will be a randomized, double-blinded prospective trial. Group A patients will be randomized to receive a TAP block with local anesthetic on the right, sham block on the left. Group B be will randomized to receive the reverse. The study population will be limited to healthy parturients undergoing elective caesarian section with spinal anesthesia (SAB) or combined spinal-epidural anesthesia (CSE) placed in the operating room at time of surgery.
Patient recruitment:
Prior to enrollment into the study informed consent will be obtained. Consent will be obtained by a study investigator blinded to the group into which the patient will be randomized. After preanesthetic counseling and patient agreement for a SAB or CSE for cesarean delivery will counsel the patient regarding study participation. Pre-operative instruction of the VAS scale shall be given by the investigator. Routine pre-operative preparations per current protocols will occur.
Intra-operative Anesthetic Regimen:
Anesthetic techniques will be per current protocols. A single intravenous infusion will be used for both intraoperative infusion of intravenous fluids during anesthetic maintenance infusion and for blood sampling for ropivicaine levels following TAP block placement.
SAB and CSE utilizing 12 mg hyperbaric bupivacaine, and 0.15mg intrathecal morphine shall be used as spinal anesthetic for all study patients. Intra-operative conduct of anesthesia will be left to the discretion of anesthesiologist caring for the parturient.
TAP Block Protocol:
At the end of the surgical procedure, if there are no new exclusion criteria, the subject will be randomized to receive bilateral TAP blocks using 30 mL containing 300 mg ropivicaine (1%) with addition of 1:300,000 epinephrine on one side (Group A on the right), and sham needle placement on the other (Group B on the right). During the procedure the study subject shall be blinded to the group assignment by surgical drapes.. The investigator who records the patient assessments will not be present at block placement. The un-blinded anesthesia provider will remove and open 1 of 22 opaque envelopes containing a card identifying the group to which the patient has been assigned by computer generated randomization. The provider will then prepare the injection syringes, labeling the ropivicaine syringe with RIGHT or LEFT according to randomization. The envelope will then be sealed and placed in the patient's study packet. An unblinded investigator trained in the block technique using ultrasound guidance will perform the block.
The TAP block shall be performed in the fashion described by Carney et. al (5). in the region of the triangle of Petit located at the superior aspect of the iliac crest, using a 22g regional block needle, utilizing the 2 pop technique(2) and needle tip position verified by ultrasound imaging. The investigator will confirm placement of the injectate in the fascial plane by initial injection of a small amount of the local anesthetic drug followed by injection of the rest of the dose with ultrasound verification of anesthetic deposition between the internal oblique and transversus abdominis. The ultrasound image will be printed and included with the study data.. The other side will receive a sham needle placement without medication injection. Because this block is performed before regression of spinal anesthesia, it causes no pain to the subject.
Post-Block Care:
Following the placement of the block, all parturients will receive a standard post-operative analgesic regimen that represents our routine practice:
- Toradol 15mg IV upon completion of surgery.
- Percocet 5/325mg q 4 hrs PRN (pain)
- Motrin 600mg q 6 hours PRN (pain)
The time to first analgesic request and administration will be recorded. The total amounts of supplemental analgesics administered will be recorded for the first 48 hours.
Following block placement, venous blood shall be drawn at set intervals described below from the indwelling venous catheter to assess ropivicaine levels.
- Conditions
- Pain Control
- Being tested
- ropivicaine, placebo
- Keywords
- Trans-abdominis block, post-cesarean
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ropivicaineDrug
Also called Trans-Abdominis Plane Block, ropivicaine, naropin
30mL containing 300mg ropivicaine 1% with addition of 1:300,000 epinepherine
placeboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| right side | Placebo comparator | The trans-abdominis block will be placed in every pat with one side being injected with ropivicaine, the other side placebo injection. Hence is subject can serve as their own control. Subjects will receive additional pain medications as needed Receives: Drug: placebo |
| Left side | Placebo comparator | The trans-abdominis block will be placed in every pat with one side being injected with ropivicaine, the other side placebo injection. Hence is subject can serve as their own control. Subjects will receive additional pain medications as needed Receives: Drug: ropivicaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in pain perception based upon VAS scores at rest between blocked and unblocked side in each subject
Measured: 4, 6, 8, 12, 16, 20 and 24 hours post TAP placement
Secondary outcomes (4)
Difference in pain perception
Measured: 4, 6, 8, 12, 16, 20, and 24 hours post TAP
Duration of time at pain perception between sides is equal
Measured: 4, 6, 8, 12, 16, 20, and 24 hours post TAP
Duration of time skin sensation of touch
Measured: 4, 6, 8, 12, 16, 20, and 24 hours post TAP
Assessment of ropivacaine levels
Measured: 4, 6, 8, 12, 16, 20, and 24 hours post TAP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2009 (estimated)
- Study startSep 2009
- Primary completionSep 2013
- Study completionSep 2013
Why it stopped: PI was unable to locate appropriate population
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ControlStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00945620
- Sponsor's protocol ID
- VUMC01TAP
- Other IDs
- TAP
- Status last verified
- Jun 2015
- First submitted
- 22 Jul 2009
- Last updated
- 8 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trans-Abdominis Plane Block Efficacy for Post-Cesarean Section Pain: A Randomized Double-Blinded Case Control Trial
- ClinicalTrials.gov ID
- NCT00945620
- Acronym / sponsor ID
- VUMC01TAP
- Conditions
- Pain Control
- Keywords
- Trans-abdominis block, post-cesarean
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI was unable to locate appropriate population
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 24 Jul 2009 (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.
The primary aim of this study is to measure the magnitude and duration of trans-abdominis plane (TAP) block analgesia in parturients undergoing elective cesarean section with concurrent standard of care operative analgesic regimens including intrathecal morphine sulfate (ITMS). A one sided block model takes advantage of the bilateral nature of the pain created by a bilateral surgical wound and allows each patient to serve as her own control. Reduced variability allows a more definitive establishment of analgesic benefit for this block.
The current reports of conflicting data regarding efficacy make uncertain the role of TAP block in post cesarean section pain relief. This model would have a better potential for measuring the block's effectiveness. Quantitative sensory evaluation tools such as the von Frey hair tool provides a quantitative reproducible measure of skin sensation and also allows for assessment of block regression over time. Pressure algometry has been established as a clinical and research tool for quantitative assessment of pain levels in multiple pain conditions. A useful inexpensive reliable pressure algometer has recently been described.
The assessment of serum ropivicaine levels with this block will provide useful data regarding the systemic absorption of local anesthetic compared to other peripheral nerve blocks and establish the safety of the technique.
In addition this study will help establish a model for the study of TAP block modifications in the future. If block effectiveness is demonstrated, this model can be used to examine numerous block parameters including choice of local anesthetic and dose response analysis for optimal volume and concentration. Potential future study may be done also in the area of adjuncts found to have increased duration and effectiveness as used in other peripheral nerve blocks.
Expected duration of this study is 18 months.
Detailed description
This will be a randomized, double-blinded prospective trial. Group A patients will be randomized to receive a TAP block with local anesthetic on the right, sham block on the left. Group B be will randomized to receive the reverse. The study population will be limited to healthy parturients undergoing elective caesarian section with spinal anesthesia (SAB) or combined spinal-epidural anesthesia (CSE) placed in the operating room at time of surgery.
Patient recruitment:
Prior to enrollment into the study informed consent will be obtained. Consent will be obtained by a study investigator blinded to the group into which the patient will be randomized. After preanesthetic counseling and patient agreement for a SAB or CSE for cesarean delivery will counsel the patient regarding study participation. Pre-operative instruction of the VAS scale shall be given by the investigator. Routine pre-operative preparations per current protocols will occur.
Intra-operative Anesthetic Regimen:
Anesthetic techniques will be per current protocols. A single intravenous infusion will be used for both intraoperative infusion of intravenous fluids during anesthetic maintenance infusion and for blood sampling for ropivicaine levels following TAP block placement.
SAB and CSE utilizing 12 mg hyperbaric bupivacaine, and 0.15mg intrathecal morphine shall be used as spinal anesthetic for all study patients. Intra-operative conduct of anesthesia will be left to the discretion of anesthesiologist caring for the parturient.
TAP Block Protocol:
At the end of the surgical procedure, if there are no new exclusion criteria, the subject will be randomized to receive bilateral TAP blocks using 30 mL containing 300 mg ropivicaine (1%) with addition of 1:300,000 epinephrine on one side (Group A on the right), and sham needle placement on the other (Group B on the right). During the procedure the study subject shall be blinded to the group assignment by surgical drapes.. The investigator who records the patient assessments will not be present at block placement. The un-blinded anesthesia provider will remove and open 1 of 22 opaque envelopes containing a card identifying the group to which the patient has been assigned by computer generated randomization. The provider will then prepare the injection syringes, labeling the ropivicaine syringe with RIGHT or LEFT according to randomization. The envelope will then be sealed and placed in the patient's study packet. An unblinded investigator trained in the block technique using ultrasound guidance will perform the block.
The TAP block shall be performed in the fashion described by Carney et. al (5). in the region of the triangle of Petit located at the superior aspect of the iliac crest, using a 22g regional block needle, utilizing the 2 pop technique(2) and needle tip position verified by ultrasound imaging. The investigator will confirm placement of the injectate in the fascial plane by initial injection of a small amount of the local anesthetic drug followed by injection of the rest of the dose with ultrasound verification of anesthetic deposition between the internal oblique and transversus abdominis. The ultrasound image will be printed and included with the study data.. The other side will receive a sham needle placement without medication injection. Because this block is performed before regression of spinal anesthesia, it causes no pain to the subject.
Post-Block Care:
Following the placement of the block, all parturients will receive a standard post-operative analgesic regimen that represents our routine practice:
- Toradol 15mg IV upon completion of surgery.
- Percocet 5/325mg q 4 hrs PRN (pain)
- Motrin 600mg q 6 hours PRN (pain)
The time to first analgesic request and administration will be recorded. The total amounts of supplemental analgesics administered will be recorded for the first 48 hours.
Following block placement, venous blood shall be drawn at set intervals described below from the indwelling venous catheter to assess ropivicaine levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| right side | Placebo comparator | Drug: placeboThe trans-abdominis block will be placed in every pat with one side being injected with ropivicaine, the other side placebo injection. Hence is subject can serve as their own control. Subjects will receive additional pain medications as needed |
| Left side | Placebo comparator | Drug: ropivicaineThe trans-abdominis block will be placed in every pat with one side being injected with ropivicaine, the other side placebo injection. Hence is subject can serve as their own control. Subjects will receive additional pain medications as needed |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Singleton pregnancy
- Pre-pregnancy body mass index less than or equal to 35
- Elective repeat cesarean section under SAB or CSE (patients in whom the epidural catheter is activated intra-operatively will be excluded)
- English-Speaking patient
- Age at least 18 and no more than 40 years old.
Key exclusion criteria (6 listed)
- Chronic pain or daily consumption of pain medications
- Neurologic disorders producing altered sensory perception or impaired motor strength in lower extremities or abdomen
- Pre-existing epidural analgesia infusion for labor analgesia.
- Spinal anesthetic failure requiring epidural catheter use or general anesthesia
- Intra-operative conversion to general anesthesia for fetal indications.
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 |
|---|---|---|
| ropivicaineAlso: Trans-Abdominis Plane Block, ropivicaine, naropin30mL containing 300mg ropivicaine 1% with addition of 1:300,000 epinepherine | Drug | Left side |
| placeboPlacebo | Drug | right side |
Primary outcome
Difference in pain perception based upon VAS scores at rest between blocked and unblocked side in each subject
Time frame: 4, 6, 8, 12, 16, 20 and 24 hours post TAP placement
4 secondary outcomes
Difference in pain perception
Time frame: 4, 6, 8, 12, 16, 20, and 24 hours post TAP
Duration of time at pain perception between sides is equal
Time frame: 4, 6, 8, 12, 16, 20, and 24 hours post TAP
Duration of time skin sensation of touch
Time frame: 4, 6, 8, 12, 16, 20, and 24 hours post TAP
Assessment of ropivacaine levels
Time frame: 4, 6, 8, 12, 16, 20, and 24 hours post TAP
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2015.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ropivicaine in people with Pain Control, run by Vanderbilt University at 1 site in United States.
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 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: withdrawn, as of the sponsor's last update on 8 Jun 2015. 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 United States. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Difference in pain perception based upon VAS scores at rest between blocked and unblocked side in each subject (time frame: 4, 6, 8, 12, 16, 20 and 24 hours post TAP placement). 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 8 Jun 2015.