Post Surgical PainPhase 2/3NCT03098420
Dose Escalation of Dexamethasone to Increase Duration of Transversus Abdominal Plane Block Following Cesarean Section
A Phase 2/3 study testing 2mg Dexamethasone, 4mg Dexamethasone and Ropivacaine (TAP blocks) in people with Post Surgical Pain, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The study aims to improve the care of the obstetric population after cesarean section and improve total patient satisfaction by improving post-surgical pain control with the use of dexamethasone in combination with bilateral TAP blocks. 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
- Post Surgical Pain
- What is being tested?
- 2mg Dexamethasone, 4mg Dexamethasone and Ropivacaine (TAP blocks)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to 20 May 2021
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Women undergoing cesarean section delivery.
- Patients classified as American Society of Anesthesiology (ASA) class II or III.
- ASA II: mild systemic disease, pregnancy
- ASA III: severe systemic disease
- Women ≥ 18 years old
- Neuraxial anesthesia (spinal) to be used as anesthetic technique intraoperatively for cesarean section (this is the UAB Anesthesiology standard of care).
Who cannot join
- Any patient not classified as an ASA I or II.
- General Anesthesia or neuraxial anesthesia with epidural used as anesthetic techniques for cesarean section.
- Allergy/intolerance to local anesthetic or steroids.
- Pre-existing neurological and/or anatomical deficit that would preclude regional block.
- Coexisting coagulopathy such as hemophilia or von Willebrand Disease
- BMI > 40.
- Emergency Cesarean Sections
Trial locations and contacts
1 site in 1 country.
United States1 site
UAB Department of Anesthesiology and Perioperative Medicine
Birmingham, Alabama, 35249
About this study
Official title: Dose Escalation of Dexamethasone to Increase Duration of Transversus Abdominal Plane Block Following Cesarean Section: A Prospective Randomized Double-Blinded Clinical Study
The study aims to improve the care of the obstetric population after cesarean section and improve total patient satisfaction by improving post-surgical pain control with the use of dexamethasone in combination with bilateral TAP blocks. The investigators will utilize a dose-escalation of dexamethasone in the TAP block to observe its effects at specific small doses. It is the hope of the investigator that the studied technique would become utilized routinely for the obstetric population following cesarean section.
The investigators hope to show that the addition of dexamethasone in bilateral TAP blocks will prolong the duration of the block in a dose-dependent fashion. The investigators hope to improve post-operative pain following cesarean section, increase duration of TAP block with use of dexamethasone, decrease overall pain scores in the first 24-48 hours, and decrease opioid requirements after cesarean section.
The primary endpoint will be estimation of duration of TAP block, being assessed within 48 hours after surgery. Secondary endpoints will include pain scores both in PACU and on the floor, average pain scores, time until first opioid administration, total opioid consumption in first 48 hours, use of PONV medications, and overall patient satisfaction.
Read the detailed description
Preoperatively: informed consent will be obtained by a member of this study. The patients will be screened for inclusion/exclusion criteria on day of procedure, and then the participants will be randomized to one of three groups.
Intraoperatively: The anesthesia team involved with care of patient in the operating room will provide routine anesthesia care during the cesarean section including neuraxial anesthesia with intrathecal bupivacaine and morphine.
After completion of the procedure, the patients will receive bilateral TAP block procedure while still in OR. All blocks will include 20mL of 0.5% ropivacaine, and the patients will be randomly assigned a specific dose of dexamethasone at 0mg (given normal saline as control), 2mg, or 4mg. The resident or attending physician supervising the block will be investigators of the study, and they along with the residents performing the blocks will be blinded to the amount of dexamethasone in the injectate.
Postoperatively: The patients will then be monitored in the PACU for approximately 30-60 minutes and then subsequently monitored on an inpatient floor. Pain scores, time until first opioid dose, total opioid requirement will be assessed and recorded. In PACU, these will be recorded every 15-30 minutes. On the inpatient floor, these will be recorded every 6 hours.
Pain scores, average pain scores in first 48 hours, total opioid consumption, time until first opioid use, and PONV medication requirement will also be recorded. These will be recorded by review of the electronic medical record.
Satisfaction scores and estimation of TAP block duration will be assessed and recorded by anesthesia personnel approximately 48 hours post-operatively; these will be subjective evaluations recorded between 24-38 hours postoperatively. The patients will be asked to estimate how long they felt the block lasted. For satisfaction scores, patients will rate their satisfaction subjectively on a scale of 1-10.
Statistical Analysis: all demographic and clinical variables with continuous measures will be expressed as means and standard deviations; categorical factors will be expressed as proportions. For non-normal data, the medians and inter quartile ranges will be displayed. The distribution of the continuous factors will be examined using the Kolmogorov-Smirnov test. For data that are normally distributed, one-way ANOVA will be used to compare groups of data. For data that are not normally distributed, the Kruskal-Wallis test will be used for comparisons. Chi-square and Fisher's exact tests will be used to analyze categorical data. For all comparisons, a value of p < 0.05 will be considered statistically significant.
Statistical analyses will be performed using SAS for Windows, version 9.2. One-way ANOVA (or the Kruskal-Wallis test, as appropriate) will be used to compare duration of TAP block for the three groups. Linear regression will also be used to test the relationship between duration of block and dexamethasone dose, while controlling for relevant clinical and demographic variables.
One-way ANOVA (or the Kruskal-Wallis test) will be used to compare the groups on post-operative pain scores, opioid requirements, and patient satisfaction scores.
Statistical Power and Sample Size Estimates: Approximately 69 subjects (23 per group) are expected to be enrolled in this study. Given this sample size and assuming that the average duration of TAP block is 18 hours for the control group, 22 hours for the 2 mg of dexamethasone group, and 24 hours for the 4 mg of dexamethasone group, this study will have approximately 80.9% power to detect a difference in block duration, assuming a common standard deviation of 6 hours. If the variability in block time is smaller than 6 hours, this study will have greater power.
- Conditions
- Post Surgical Pain
- Being tested
- 2mg Dexamethasone, 4mg Dexamethasone, Ropivacaine (TAP blocks), Morphine, Bupivacaine Hydrochloride
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2mg DexamethasoneDrug
Also called Baycadron, Maxidex, Decadron
0.5 mL (2mg) of dexamethasone and 0.5 ml of normal saline
4mg DexamethasoneDrug
Also called Baycadron, Maxidex, Decadron
1 mL (4mg) of dexamethasone
Ropivacaine (TAP blocks)Drug
20mL of 0% ropivacaine with 20mL of 0.5% ropivacaine
MorphineDrug
Bupivacaine HydrochlorideDrug
Normal saline 1mlDrug
1.0 ml of normal saline split between 2 sites with standard intrathecal bupivacaine and morphine
Normal saline 0.5mlDrug
0.5 ml of normal saline split between 2 sites with standard intrathecal bupivacaine and morphine
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | 20 patients. Each patient will receive postoperative bilateral TAP blocks (20mL of ropivacaine) and 1mL of normal saline bilaterally (control) with standard intrathecal bupivacaine and morphine. Receives: Drug: Ropivacaine (TAP blocks); Drug: Morphine; Drug: Bupivacaine Hydrochloride; Drug: Normal saline 1ml |
| 2mg Dexamethasone | Active comparator | 20 patients. Each patient will receive postoperative bilateral TAP blocks (20mL of 0.5% ropivacaine) with 0.5 mL (2mg) of dexamethasone and 0.5 ml of normal saline split between 2 sides with standard intrathecal bupivacaine and morphine. Receives: Drug: 2mg Dexamethasone; Drug: Ropivacaine (TAP blocks); Drug: Morphine; Drug: Bupivacaine Hydrochloride; Drug: Normal saline 0.5ml |
| 4mg Dexamethasone | Active comparator | 20 patients. Each patient will receive postoperative bilateral TAP blocks (20mL of 0.5% ropivacaine) with 20mL of 0.5% ropivacaine) and 1 mL (4mg) of dexamethasone between 2 sides with standard intrathecal bupivacaine and morphine. Receives: Drug: 4mg Dexamethasone; Drug: Ropivacaine (TAP blocks); Drug: Morphine; Drug: Bupivacaine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Pain Score
Average pain score (VAS) 48 hrs postoperatively between the study group and the control. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. 0 represents no pain, whereas 10 represents unbearable pain.
Measured: 48 hours postoperatively
Secondary outcomes (2)
First Post-Operative Opioid Administration
Time until first dose post-operative opioid administration between the study group and the control
Measured: baseline to 48 hrs postoperatively
Average Opioid Consumption
Average opioid consumption 48 hrs postoperatively between the study group and the control
Measured: from the time of delivery to 48hrs postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2017
- Study startJul 2016
- Primary completion20 May 2021
- Study completion20 May 2021
Why it stopped: Low enrollment; recruitment challenges due to competing studies in women and infant center
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post Surgical PainStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomly assigned to 1 of 3 groups. They will be assigned to a group prior to being brought back to the operating room. The anesthesia team in the OR will take an envelope that has which group the patient will be randomly assigned to and they will perform the TAP block with the respective dose of dexamethasone. The anesthesia team that performs the block, along with the supervising PI or sub-investigator, will be blinded to the medication in the injectate
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joel Feinstein, MD, University of Alabama at Birmingham
- Investigators
- Joel Feinstein, MD, Principal investigator, Anesthesiology ad Perioperative Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03098420
- Sponsor's protocol ID
- F160421006
- Status last verified
- May 2021
- First submitted
- 13 Mar 2017
- Last updated
- 18 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Escalation of Dexamethasone to Increase Duration of Transversus Abdominal Plane Block Following Cesarean Section: A Prospective Randomized Double-Blinded Clinical Study
- ClinicalTrials.gov ID
- NCT03098420
- Acronym / sponsor ID
- F160421006
- Conditions
- Post Surgical Pain
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment; recruitment challenges due to competing studies in women and infant center
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- 20 May 2021 (actual)
- Study completion
- 20 May 2021 (actual)
- First posted
- 31 Mar 2017 (actual)
- Results
- Posted 18 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to improve the care of the obstetric population after cesarean section and improve total patient satisfaction by improving post-surgical pain control with the use of dexamethasone in combination with bilateral TAP blocks. The investigators will utilize a dose-escalation of dexamethasone in the TAP block to observe its effects at specific small doses. It is the hope of the investigator that the studied technique would become utilized routinely for the obstetric population following cesarean section.
The investigators hope to show that the addition of dexamethasone in bilateral TAP blocks will prolong the duration of the block in a dose-dependent fashion. The investigators hope to improve post-operative pain following cesarean section, increase duration of TAP block with use of dexamethasone, decrease overall pain scores in the first 24-48 hours, and decrease opioid requirements after cesarean section.
The primary endpoint will be estimation of duration of TAP block, being assessed within 48 hours after surgery. Secondary endpoints will include pain scores both in PACU and on the floor, average pain scores, time until first opioid administration, total opioid consumption in first 48 hours, use of PONV medications, and overall patient satisfaction.
Detailed description
Preoperatively: informed consent will be obtained by a member of this study. The patients will be screened for inclusion/exclusion criteria on day of procedure, and then the participants will be randomized to one of three groups.
Intraoperatively: The anesthesia team involved with care of patient in the operating room will provide routine anesthesia care during the cesarean section including neuraxial anesthesia with intrathecal bupivacaine and morphine.
After completion of the procedure, the patients will receive bilateral TAP block procedure while still in OR. All blocks will include 20mL of 0.5% ropivacaine, and the patients will be randomly assigned a specific dose of dexamethasone at 0mg (given normal saline as control), 2mg, or 4mg. The resident or attending physician supervising the block will be investigators of the study, and they along with the residents performing the blocks will be blinded to the amount of dexamethasone in the injectate.
Postoperatively: The patients will then be monitored in the PACU for approximately 30-60 minutes and then subsequently monitored on an inpatient floor. Pain scores, time until first opioid dose, total opioid requirement will be assessed and recorded. In PACU, these will be recorded every 15-30 minutes. On the inpatient floor, these will be recorded every 6 hours.
Pain scores, average pain scores in first 48 hours, total opioid consumption, time until first opioid use, and PONV medication requirement will also be recorded. These will be recorded by review of the electronic medical record.
Satisfaction scores and estimation of TAP block duration will be assessed and recorded by anesthesia personnel approximately 48 hours post-operatively; these will be subjective evaluations recorded between 24-38 hours postoperatively. The patients will be asked to estimate how long they felt the block lasted. For satisfaction scores, patients will rate their satisfaction subjectively on a scale of 1-10.
Statistical Analysis: all demographic and clinical variables with continuous measures will be expressed as means and standard deviations; categorical factors will be expressed as proportions. For non-normal data, the medians and inter quartile ranges will be displayed. The distribution of the continuous factors will be examined using the Kolmogorov-Smirnov test. For data that are normally distributed, one-way ANOVA will be used to compare groups of data. For data that are not normally distributed, the Kruskal-Wallis test will be used for comparisons. Chi-square and Fisher's exact tests will be used to analyze categorical data. For all comparisons, a value of p < 0.05 will be considered statistically significant.
Statistical analyses will be performed using SAS for Windows, version 9.2. One-way ANOVA (or the Kruskal-Wallis test, as appropriate) will be used to compare duration of TAP block for the three groups. Linear regression will also be used to test the relationship between duration of block and dexamethasone dose, while controlling for relevant clinical and demographic variables.
One-way ANOVA (or the Kruskal-Wallis test) will be used to compare the groups on post-operative pain scores, opioid requirements, and patient satisfaction scores.
Statistical Power and Sample Size Estimates: Approximately 69 subjects (23 per group) are expected to be enrolled in this study. Given this sample size and assuming that the average duration of TAP block is 18 hours for the control group, 22 hours for the 2 mg of dexamethasone group, and 24 hours for the 4 mg of dexamethasone group, this study will have approximately 80.9% power to detect a difference in block duration, assuming a common standard deviation of 6 hours. If the variability in block time is smaller than 6 hours, this study will have greater power.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Patients will be randomly assigned to 1 of 3 groups. They will be assigned to a group prior to being brought back to the operating room. The anesthesia team in the OR will take an envelope that has which group the patient will be randomly assigned to and they will perform the TAP block with the respective dose of dexamethasone. The anesthesia team that performs the block, along with the supervising PI or sub-investigator, will be blinded to the medication in the injectate
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Drug: Ropivacaine (TAP blocks), Drug: Morphine, Drug: Bupivacaine Hydrochloride, Drug: Normal saline 1ml20 patients. Each patient will receive postoperative bilateral TAP blocks (20mL of ropivacaine) and 1mL of normal saline bilaterally (control) with standard intrathecal bupivacaine and morphine. |
| 2mg Dexamethasone | Active comparator | Drug: 2mg Dexamethasone, Drug: Ropivacaine (TAP blocks), Drug: Morphine, Drug: Bupivacaine Hydrochloride, Drug: Normal saline 0.5ml20 patients. Each patient will receive postoperative bilateral TAP blocks (20mL of 0.5% ropivacaine) with 0.5 mL (2mg) of dexamethasone and 0.5 ml of normal saline split between 2 sides with standard intrathecal bupivacaine and morphine. |
| 4mg Dexamethasone | Active comparator | Drug: 4mg Dexamethasone, Drug: Ropivacaine (TAP blocks), Drug: Morphine, Drug: Bupivacaine Hydrochloride20 patients. Each patient will receive postoperative bilateral TAP blocks (20mL of 0.5% ropivacaine) with 20mL of 0.5% ropivacaine) and 1 mL (4mg) of dexamethasone between 2 sides with standard intrathecal bupivacaine and morphine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women undergoing cesarean section delivery.
- Patients classified as American Society of Anesthesiology (ASA) class II or III.
- Women ≥ 18 years old
- Neuraxial anesthesia (spinal) to be used as anesthetic technique intraoperatively for cesarean section (this is the UAB Anesthesiology standard of care).
Key exclusion criteria (7 listed)
- Any patient not classified as an ASA I or II.
- General Anesthesia or neuraxial anesthesia with epidural used as anesthetic techniques for cesarean section.
- Allergy/intolerance to local anesthetic or steroids.
- Pre-existing neurological and/or anatomical deficit that would preclude regional block.
- Coexisting coagulopathy such as hemophilia or von Willebrand Disease
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 |
|---|---|---|
| 2mg DexamethasoneAlso: Baycadron, Maxidex, Decadron0.5 mL (2mg) of dexamethasone and 0.5 ml of normal saline | Drug | 2mg Dexamethasone |
| 4mg DexamethasoneAlso: Baycadron, Maxidex, Decadron1 mL (4mg) of dexamethasone | Drug | 4mg Dexamethasone |
| Ropivacaine (TAP blocks)20mL of 0% ropivacaine with 20mL of 0.5% ropivacaine | Drug | 2mg Dexamethasone, 4mg Dexamethasone, Control Group |
| Morphine | Drug | 2mg Dexamethasone, 4mg Dexamethasone, Control Group |
| Bupivacaine Hydrochloride | Drug | 2mg Dexamethasone, 4mg Dexamethasone, Control Group |
| Normal saline 1ml1.0 ml of normal saline split between 2 sites with standard intrathecal bupivacaine and morphine | Drug | Control Group |
| Normal saline 0.5ml0.5 ml of normal saline split between 2 sites with standard intrathecal bupivacaine and morphine | Drug | 2mg Dexamethasone |
Primary outcome
Average Pain Score
Time frame: 48 hours postoperatively
Average pain score (VAS) 48 hrs postoperatively between the study group and the control. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. 0 represents no pain, whereas 10 represents unbearable pain.
2 secondary outcomes
First Post-Operative Opioid Administration
Time frame: baseline to 48 hrs postoperatively
Average Opioid Consumption
Time frame: from the time of delivery to 48hrs postoperatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Post Surgical Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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.
Joel Feinstein, MD principal investigator
Anesthesiology ad Perioperative Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing 2mg Dexamethasone, 4mg Dexamethasone and Ropivacaine (TAP blocks) in people with Post Surgical Pain, run by University of Alabama at Birmingham 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 6 inclusion and 7 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: stopped early, as of the sponsor's last update on 18 Jun 2021. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Average Pain Score (time frame: 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 18 Jun 2021.