Trial · NCT02996227
Bilateral Transversus Abdominis Plane Block With Exparel Verus Continuous Epidural Analgesia With Bupivacaine
NCT02996227, Not applicable, Completed, The Cleveland Clinic; results first posted 2024-01-31
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Bilateral Transversus Abdominis Plane Block With Exparel Verus Continuous Epidural Analgesia With Bupivacaine. Trials, record NCT02996227. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02996227
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bilateral Transversus Abdominis Plane Block With Exparel Verus Continuous Epidural Analgesia With Bupivacaine
- NCT number
- NCT02996227
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 514 participants, actual
- Lead sponsor
- The Cleveland Clinic
- Conditions
- Pain, Postoperative, Major Abdominal Surgery
- Interventions
- TAP block, Epidural analgesia, EXPAREL, Bupivacaine
- First posted
- 2016-12-19
- Last updated
- 2024-01-31
- Results first posted
- 2024-01-31
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | VRS Pain Score | The Verbal Response Scale was recorded every 4 hours for 72 hours after discharge from the PACU. | Pain scores will be measured using a Verbal Response Scale (VRS). VRS is a scale from 0 to 10 where 0 signifies no pain and 10 signifies the worst pain ever experienced. The VRS will be recorded every 4 hours for 72 hours after discharge from the PACU. Summary statistics of pain scores are reported as means ± standard deviations of average pain during the first 72 postoperative hours |
| Primary | Total Opioid Consumption | During the 72 hours after discharge from the PACU. | Opioid consumption will be measured as the total amount of opioids (converted to morphine sulfate equivalents) used during the 72 hours after the end of surgery. |
| Secondary | Cumulative Duration of Activity | During the initial 72 postoperative hours. | defined as the total duration of time patients spent sitting or standing, as determined by the mobile monitoring system during the initial 72 postoperative hours. |
| Secondary | Opioid-related Side Effect | The first, second and third postoperative mornings | We will use 4-point Opioid-Related Symptom Distress Scale (ORSDS) to evaluate the frequency, severity, and bothersomeness of: nausea, vomiting, constipation, difficulty passing urine, difficulty concentrating,drowsiness or difficulty staying awake, feeling lightheaded or dizzy,feeling confused, feelings of general fatigue or weakness, itchiness, dry mouth, and headache. Severity: 1=Slightly severe 2=Moderately severe 3=Severe 4=Very severe; Frequency: 1=Rarely 2=Occasionally 3=Frequently 4=Almost constantly; Bothersomeness (rescaled to a 4-point scale): 0.8=not at all 1.6=a little bit 2.4= somewhat 3.2=quite a bit 4.0=very much. If a patient did not experience the symptom in the past 24 hours, a score of 0 was assigned to each domain. Opioid-related side effect is the sum of the patient's frequency, severity, and bothersomeness, scored from 0 to 12. Higher scores indicate greater severity. |
| Secondary | Hemodynamic Instability, Defined as Mean Arterial Pressure (MAP) <55 mmHg or Systolic Blood Pressure <80 mmHg. | Data was recorded at 15-s intervals during the initial 72 postoperative hours. | Visi mobile patient monitoring system will be used to obtain the blood pressure of the patient for 72 hours. Data was recorded at 15-s intervals and downloaded daily to a laptop. We re-defined postoperative hypotension as any MAP \<65 mmHg, because few patients experienced such profound hypotension as originally planned and because papers published since the trial were designed to identify 65 mmHg as the harm threshold for both myocardial and renal injury. Summary statistics of hemodynamic instability are reported as means ± standard deviations of average MAP during the first 72 postoperative hours. |
| Secondary | Quality of Recovery After Anesthesia | The first and third postoperative mornings | Quality of recovery (QoR) will be measured using QoR-15 questionnaire which includes 15 11-point numerical rating scale. For positive items, 0 = "none of the time \[poor\]" to 10 = "all of the time \[excellent\]"; Conversely, for negative items, 10 = "none of the time \[excellent\]" to 0 = "all of the time \[poor\]". Quality of recovery is the sum of all the 15 questions, with a score ranging from 0 (extremely poor QoR) to 150 (excellent QoR). |
| Secondary | Length of Hospital Stay | From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 100 weeks | The length of hospital stay will be measured as days. |
| Other | Duration of Hypoxemia | Data was recorded at 15-s intervals during the initial 72 postoperative hours. | ViSi mobile (Sotera Wireless) patient monitoring system will be used to obtain vital signs including SpO2 of the patient for 72 hours. Data was recorded at 15-s intervals and downloaded daily to a laptop. The outcome is area-under-the-curve for saturation over time with the threshold set at 90%. |
| Other | Persistent Postoperative Incisional Pain- MBPI Pain Intensity | At the 90-day follow up | Defined by the presence of pain at three months and its characteristics as determined by Modified Brief Pain Inventory (MBPI) questionnaires. The modified BPI contains 4 intensity items and 5 interference items with 0-to-10 numerical rating scales. For intensity items: 0 = "no pain" and 10 = "pain as bad as you can imagine."; and for interference items, 0 = "does not interfere" and 10 = "interferes completely." The pain intensity is the sum of the patient's worst, average, least, and current pain intensity, with a score ranging from 0 (no pain) to 40 (pain as bad as you can imagine); and pain Interference is the sum of walking ability, mood, sleep, relations with others, and ability to concentrate, with a score ranging from 0 (does not interfere) to 50 (interferes completely). |
| Other | Persistent Postoperative Incisional Pain- MBPI Pain Interference | At the 90-day follow up | Defined by the presence of pain at three months and its characteristics as determined by Modified Brief Pain Inventory (MBPI) questionnaires. The modified BPI contains 4 intensity items and 5 interference items with 0-to-10 numerical rating scales. For intensity items: 0 = "no pain" and 10 = "pain as bad as you can imagine."; and for interference items, 0 = "does not interfere" and 10 = "interferes completely." The pain intensity is the sum of the patient's worst, average, least, and current pain intensity, with a score ranging from 0 (no pain) to 40 (pain as bad as you can imagine); and pain Interference is the sum of walking ability, mood, sleep, relations with others, and ability to concentrate, with a score ranging from 0 (does not interfere) to 50 (interferes completely). |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | VRS Pain Score | The Verbal Response Scale was recorded every 4 hours for 72 hours after discharge from the PACU. | Two patients had missing outcomes due to the cancellation of surgery in Epidural analgesia with Bupivacaine group. | score on a scale | MEAN |
| PRIMARY | Total Opioid Consumption | During the 72 hours after discharge from the PACU. | Two patients had missing outcomes due to the cancellation of surgery in Epidural analgesia with Bupivacaine group. | mg | MEDIAN |
| SECONDARY | Cumulative Duration of Activity | During the initial 72 postoperative hours. | hours | MEDIAN | |
| SECONDARY | Opioid-related Side Effect | The first, second and third postoperative mornings | score on a scale | MEDIAN | |
| SECONDARY | Hemodynamic Instability, Defined as Mean Arterial Pressure (MAP) <55 mmHg or Systolic Blood Pressure <80 mmHg. | Data was recorded at 15-s intervals during the initial 72 postoperative hours. | mmHg | MEAN | |
| SECONDARY | Quality of Recovery After Anesthesia | The first and third postoperative mornings | score on a scale | MEAN | |
| SECONDARY | Length of Hospital Stay | From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 100 weeks | days | MEDIAN | |
| OTHER_PRE_SPECIFIED | Duration of Hypoxemia | Data was recorded at 15-s intervals during the initial 72 postoperative hours. | min/h | MEDIAN | |
| OTHER_PRE_SPECIFIED | Persistent Postoperative Incisional Pain- MBPI Pain Intensity | At the 90-day follow up | score on a scale | MEDIAN | |
| OTHER_PRE_SPECIFIED | Persistent Postoperative Incisional Pain- MBPI Pain Interference | At the 90-day follow up | score on a scale | MEDIAN |
Source ClinicalTrials.gov
Results by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| VRS Pain Score | TAP Block With Exparel | 4.3 | Standard Deviation 1.8 | score on a scale | |
| VRS Pain Score | Epidural Analgesia With Bupivacaine | 4.2 | Standard Deviation 1.8 | score on a scale | |
| Total Opioid Consumption | TAP Block With Exparel | 56 | Inter-Quartile Range 20 to 122 | mg | |
| Total Opioid Consumption | Epidural Analgesia With Bupivacaine | 35 | Inter-Quartile Range 13 to 94 | mg | |
| Cumulative Duration of Activity | TAP Block With Exparel | 1.1 | Inter-Quartile Range 0.2 to 3.4 | hours | |
| Cumulative Duration of Activity | Epidural Analgesia With Bupivacaine | 1.0 | Inter-Quartile Range 0.1 to 3.8 | hours | |
| Opioid-related Side Effect | TAP Block With Exparel | POD 1 | 5.8 | Inter-Quartile Range 2.3 to 9.7 | score on a scale |
| Opioid-related Side Effect | Epidural Analgesia With Bupivacaine | POD 1 | 5.5 | Inter-Quartile Range 2.8 to 9.6 | score on a scale |
| Opioid-related Side Effect | TAP Block With Exparel | POD 2 | 4.9 | Inter-Quartile Range 1.9 to 9.1 | score on a scale |
| Opioid-related Side Effect | Epidural Analgesia With Bupivacaine | POD 2 | 4.5 | Inter-Quartile Range 1.3 to 8.4 | score on a scale |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | TAP Block With Exparel | 260 | |
| Overall Study | STARTED | Epidural Analgesia With Bupivacaine | 254 | |
| Overall Study | COMPLETED | TAP Block With Exparel | 255 | |
| Overall Study | COMPLETED | Epidural Analgesia With Bupivacaine | 243 | |
| Overall Study | NOT COMPLETED | TAP Block With Exparel | 5 | |
| Overall Study | NOT COMPLETED | Epidural Analgesia With Bupivacaine | 11 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TAP Block With Exparel | 0 | 255 |
| Total, all-cause mortality | Epidural Analgesia With Bupivacaine | 0 | 243 |
| Total, other adverse events | TAP Block With Exparel | 0 | 255 |
| Total, other adverse events | Epidural Analgesia With Bupivacaine | 0 | 243 |
| Total, serious adverse events | TAP Block With Exparel | 0 | 255 |
| Total, serious adverse events | Epidural Analgesia With Bupivacaine | 0 | 243 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34969004 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| TAP Block With Exparel vs Epidural Analgesia With Bupivacaine: deaths from any cause | Trial comparisons |
| TAP Block With Exparel vs Epidural Analgesia With Bupivacaine: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02996227
GET https://conductscience.org/api/trials/v1/NCT02996227/results?page=2