Trial · NCT02111746
PAIN - Postoperative Analgesia INvestigation
NCT02111746, Phase 4, Completed, The University of Texas Health Science Center, Houston; results first posted 2018-10-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. PAIN - Postoperative Analgesia INvestigation. Trials, record NCT02111746. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02111746
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PAIN - Postoperative Analgesia INvestigation
- NCT number
- NCT02111746
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 350 participants, actual
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Conditions
- Postoperative Pain
- Interventions
- Exparel, Bupivacaine hydrochloride, Patient Controlled Analgesia (PCA)
- First posted
- 2014-04-11
- Last updated
- 2018-10-16
- Results first posted
- 2018-10-16
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Postoperative Pain as Assessed by a Numeric Pain Scale (NPS) | postoperative day 1 | The Numeric Pain Scale (NPS) ranges from 0 ("no pain") to 10 ("worst possible pain"). |
| Primary | Postoperative Pain as Assessed by a Numeric Pain Scale (NPS) | postoperative day 2 | The Numeric Pain Scale (NPS) ranges from 0 ("no pain") to 10 ("worst possible pain"). |
| Primary | Postoperative Pain as Assessed by a Numeric Pain Scale (NPS) | postoperative day 3 | The Numeric Pain Scale (NPS) ranges from 0 ("no pain") to 10 ("worst possible pain"). |
| Primary | Postoperative Pain as Assessed by a Five-point Satisfaction Scale | postoperative day 1 | The 5-point satisfaction scale ranges from 1 (extremely dissatisfied) to 5 (extremely satisfied). |
| Primary | Postoperative Pain as Assessed by a Five-point Satisfaction Scale | postoperative day 2 | The 5-point satisfaction scale ranges from 1 (extremely dissatisfied) to 5 (extremely satisfied). |
| Primary | Postoperative Pain as Assessed by a Five-point Satisfaction Scale | postoperative day 3 | The 5-point satisfaction scale ranges from 1 (extremely dissatisfied) to 5 (extremely satisfied). |
| Primary | Postoperative Pain as Assessed by the Brief Pain Inventory (BPI) | postoperative day 1 | The Brief Pain Inventory (BPI) ranges from 0 ("no pain") to 10 ("worst pain you can imagine"). |
| Primary | Postoperative Pain as Assessed by the Brief Pain Inventory (BPI) | postoperative day 2 | The Brief Pain Inventory (BPI) ranges from 0 ("no pain") to 10 ("worst pain you can imagine"). |
| Primary | Postoperative Pain as Assessed by the Brief Pain Inventory (BPI) | postoperative day 3 | The Brief Pain Inventory (BPI) ranges from 0 ("no pain") to 10 ("worst pain you can imagine"). |
| Secondary | Overall Opioid Use | Over the first 72 hours after surgery | The total amount in mg of opioid medication consumed through 12, 24, 36, 48, 60, and 72 hours after surgery will be assessed. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Postoperative Pain as Assessed by a Numeric Pain Scale (NPS) | postoperative day 1 | Intention-to-treat analysis. Data for this measure was collected for only 153 in the Exparel arm and 152 in the Regular Bupivacaine group. | units on a scale | MEAN |
| PRIMARY | Postoperative Pain as Assessed by a Numeric Pain Scale (NPS) | postoperative day 2 | Intention-to-treat analysis. Data for this measure was collected for only 160 in the Exparel arm and 159 in the Regular Bupivacaine group. | units on a scale | MEAN |
| PRIMARY | Postoperative Pain as Assessed by a Numeric Pain Scale (NPS) | postoperative day 3 | Intention-to-treat analysis. Data for this measure was collected for only 159 in the Exparel arm and 151 in the Regular Bupivacaine group. | units on a scale | MEAN |
| PRIMARY | Postoperative Pain as Assessed by a Five-point Satisfaction Scale | postoperative day 1 | Intention-to-treat analysis. Data for this measure was collected for only 144 in the Exparel arm and 146 in the Regular Bupivacaine group. | units on a scale | MEAN |
| PRIMARY | Postoperative Pain as Assessed by a Five-point Satisfaction Scale | postoperative day 2 | Intention-to-treat analysis. Data for this measure was collected for only 155 in the Exparel arm and 155 in the Regular Bupivacaine group. | units on a scale | MEAN |
| PRIMARY | Postoperative Pain as Assessed by a Five-point Satisfaction Scale | postoperative day 3 | Intention-to-treat analysis. Data for this measure was collected for only 148 in the Exparel arm and 148 in the Regular Bupivacaine group. | units on a scale | MEAN |
| PRIMARY | Postoperative Pain as Assessed by the Brief Pain Inventory (BPI) | postoperative day 1 | Intention-to-treat analysis. Data for this measure was collected for only 142 in the Exparel arm and 140 in the Regular Bupivacaine group. | units on a scale | MEAN |
| PRIMARY | Postoperative Pain as Assessed by the Brief Pain Inventory (BPI) | postoperative day 2 | Intention-to-treat analysis. Data for this measure was collected for only 151 in the Exparel arm and 149 in the Regular Bupivacaine group. | units on a scale | MEAN |
| PRIMARY | Postoperative Pain as Assessed by the Brief Pain Inventory (BPI) | postoperative day 3 | Intention-to-treat analysis. Data for this measure was collected for only 150 in the Exparel arm and 135 in the Regular Bupivacaine group. | units on a scale | MEAN |
| SECONDARY | Overall Opioid Use | Over the first 72 hours after surgery |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Postoperative Pain as Assessed by a Numeric Pain Scale (NPS) | Exparel® | 5.05 | Standard Deviation 2.8 | units on a scale | |
| Postoperative Pain as Assessed by a Numeric Pain Scale (NPS) | Regular Bupivacaine | 5.02 | Standard Deviation 2.68 | units on a scale | |
| Postoperative Pain as Assessed by a Numeric Pain Scale (NPS) | Exparel® | 4.69 | Standard Deviation 2.49 | units on a scale | |
| Postoperative Pain as Assessed by a Numeric Pain Scale (NPS) | Regular Bupivacaine | 4.08 | Standard Deviation 2.64 | units on a scale | |
| Postoperative Pain as Assessed by a Numeric Pain Scale (NPS) | Exparel® | 3.71 | Standard Deviation 2.42 | units on a scale | |
| Postoperative Pain as Assessed by a Numeric Pain Scale (NPS) | Regular Bupivacaine | 3.03 | Standard Deviation 2.47 | units on a scale | |
| Postoperative Pain as Assessed by a Five-point Satisfaction Scale | Exparel® | 4.08 | Standard Deviation 1.16 | units on a scale | |
| Postoperative Pain as Assessed by a Five-point Satisfaction Scale | Regular Bupivacaine | 3.99 | Standard Deviation 1.35 | units on a scale | |
| Postoperative Pain as Assessed by a Five-point Satisfaction Scale | Exparel® | 4.23 | Standard Deviation 1.05 | units on a scale | |
| Postoperative Pain as Assessed by a Five-point Satisfaction Scale | Regular Bupivacaine | 4.12 | Standard Deviation 1.33 | units on a scale |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Exparel® | 172 | |
| Overall Study | STARTED | Regular Bupivacaine | 171 | |
| Overall Study | COMPLETED | Exparel® | 169 | |
| Overall Study | COMPLETED | Regular Bupivacaine | 169 | |
| Overall Study | NOT COMPLETED | Exparel® | 3 | |
| Overall Study | NOT COMPLETED | Regular Bupivacaine | 2 |
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 | Exparel® | 4 | 171 |
| Total, all-cause mortality | Regular Bupivacaine | 2 | 175 |
| Total, other adverse events | Exparel® | 0 | 171 |
| Total, other adverse events | Regular Bupivacaine | 0 | 175 |
| Total, serious adverse events | Exparel® | 0 | 171 |
| Total, serious adverse events | Regular Bupivacaine | 0 | 175 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33724391 | 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 |
|---|---|
| Exparel® vs Regular Bupivacaine: deaths from any cause | Trial comparisons |
| Exparel® vs Regular 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/NCT02111746
GET https://conductscience.org/api/trials/v1/NCT02111746/registered