HemorrhoidPhase 4NCT02104414
Efficacy of Rectal Infiltration of Exparel for Analgesic Benefit Following Hemorrhoidectomy
A Phase 4 study testing Exparel, Bupivacaine HCl with Epinephrine and Normal Saline in people with Hemorrhoid, run by St. Luke's-Roosevelt Hospital Center at 1 site in United States.
Trial summary
The purpose of this study is to compare the quality and duration of pain relief after a hemorrhoidectomy, provided by locally administered liposomal bupivacaine versus bupivacaine hcl or control with saline. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemorrhoid
- What is being tested?
- Exparel, Bupivacaine HCl with Epinephrine and Normal Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Jan 2016
- Phase
- Phase 4
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients undergoing hemorrhoidectomy for grade 3 or 4 hemorrhoids who are English-speaking patients, 21-65 yr of age, ASA physical status I-III, BMI<30
Who cannot join
- contraindications to administration of local anesthesia (e.g., local anesthetic allergy), difficult airway (Mallampati>2), psychiatric or cognitive disorders, pregnancy , and history of substance abuse or chronic opioid use
Trial locations and contacts
1 site in 1 country.
United States1 site
St.Luke's-Roosevelt Hospital Center
New York, New York, 10027
About this study
Official title: Comparison of Rectal Infiltration of Exparel vs. 0.25% Bupivacaine With Epinephrine vs. Placebo for Analgesic Benefit Following Hemorrhoidectomy
The purpose of this study is to compare the quality and duration of pain relief after a hemorrhoidectomy, provided by locally administered liposomal bupivacaine versus bupivacaine hcl or control with saline. It is hypothesized that liposomal bupivacaine will provide more effective postoperative pain relief than both bupivacaine hcl and the control.
- Conditions
- Hemorrhoid
- Being tested
- Exparel, Bupivacaine HCl with Epinephrine, Normal Saline
- Keywords
- Liposomal Bupivacaine, Exparel
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExparelDrug
Also called Liposomal Bupivacaine
266 mg/20mL Exparel (to be diluted with 10 mL sterile saline to make 30 mL)
Bupivacaine HCl with EpinephrineDrug
75mg/30mL 0.25% Bupivacaine HCl with epinephrine
Normal SalineDrug
30mL Normal Saline
| Study group | Role | What they receive |
|---|---|---|
| Exparel | Active comparator | 266mg/20mL Exparel (to be diluted with 10 mL sterile saline to make 30 mL) Receives: Drug: Exparel |
| Bupivacaine HCl with epinephrine | Active comparator | 75mg/30mL 0.25% Bupivacaine HCl with epinephrine Receives: Drug: Bupivacaine HCl with Epinephrine |
| Normal Saline | Placebo comparator | 30mL Normal Saline Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post Operative Pain Control
The primary objective is to evaluate analgesia following local infiltration of 30 mL Exparel or the same volume of 0.25% bupivacaine HCl with epinephrine or normal saline. The intensity of pain will be measured using a numerical rating scale (NRS-11) in which 0 represents no pain, and 10 represents extreme pain.
Measured: up to 4 days
Secondary outcomes (5)
Number of Oxycodone Tablets Taken
Number of postoperative opioid consumption - oxycodone tablets (5mg each)
Measured: up to 4 days
Postoperative Opioid Consumption - Hydromorphone I.V
Measured: 1 hour and 2 hours post op
Number of Participants With Postoperative Nausea and Vomiting
Number of participants with postoperative nausea and vomiting episodes
Measured: up to 4 days
Number of Participants With Pain During Bowel Movements
Number of participants with pain during postoperative bowel movements
Measured: Hourly from PACU arrival to discharge and Q4H from 10:00-22:00 postoperatively for 4 days
Number of Participants With Urinary Retention
Measured: up to 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionJan 2016
- Study completionJan 2016
Why it stopped: low enrollment
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 HemorrhoidStudies 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Luke's-Roosevelt Hospital Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ali Shariat, MD, Principal investigator, St. Luke's-Roosevelt Hospital Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02104414
- Sponsor's protocol ID
- 13-0062
- Status last verified
- Dec 2018
- First submitted
- 28 Mar 2014
- Last updated
- 4 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Rectal Infiltration of Exparel vs. 0.25% Bupivacaine With Epinephrine vs. Placebo for Analgesic Benefit Following Hemorrhoidectomy
- ClinicalTrials.gov ID
- NCT02104414
- Acronym / sponsor ID
- 13-0062
- Conditions
- Hemorrhoid
- Keywords
- Liposomal Bupivacaine, Exparel
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low enrollment
- Enrolment
- 11 participants (actual)
- Lead sponsor
- St. Luke's-Roosevelt Hospital CenterUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 4 Apr 2014 (estimated)
- Results
- Posted 4 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the quality and duration of pain relief after a hemorrhoidectomy, provided by locally administered liposomal bupivacaine versus bupivacaine hcl or control with saline. It is hypothesized that liposomal bupivacaine will provide more effective postoperative pain relief than both bupivacaine hcl and the control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exparel | Active comparator | Drug: Exparel266mg/20mL Exparel (to be diluted with 10 mL sterile saline to make 30 mL) |
| Bupivacaine HCl with epinephrine | Active comparator | Drug: Bupivacaine HCl with Epinephrine75mg/30mL 0.25% Bupivacaine HCl with epinephrine |
| Normal Saline | Placebo comparator | Drug: Normal Saline30mL Normal Saline |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing hemorrhoidectomy for grade 3 or 4 hemorrhoids who are English-speaking patients, 21-65 yr of age, ASA physical status I-III, BMI<30
Key exclusion criteria (1 listed)
- contraindications to administration of local anesthesia (e.g., local anesthetic allergy), difficult airway (Mallampati>2), psychiatric or cognitive disorders, pregnancy , and history of substance abuse or chronic opioid use
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 |
|---|---|---|
| ExparelAlso: Liposomal Bupivacaine266 mg/20mL Exparel (to be diluted with 10 mL sterile saline to make 30 mL) | Drug | Exparel |
| Bupivacaine HCl with Epinephrine75mg/30mL 0.25% Bupivacaine HCl with epinephrine | Drug | Bupivacaine HCl with epinephrine |
| Normal Saline30mL Normal Saline | Drug | Normal Saline |
Primary outcome
Post Operative Pain Control
Time frame: up to 4 days
The primary objective is to evaluate analgesia following local infiltration of 30 mL Exparel or the same volume of 0.25% bupivacaine HCl with epinephrine or normal saline. The intensity of pain will be measured using a numerical rating scale (NRS-11) in which 0 represents no pain, and 10 represents extreme pain.
5 secondary outcomes
Number of Oxycodone Tablets Taken
Time frame: up to 4 days
Postoperative Opioid Consumption - Hydromorphone I.V
Time frame: 1 hour and 2 hours post op
Number of Participants With Postoperative Nausea and Vomiting
Time frame: up to 4 days
Number of Participants With Pain During Bowel Movements
Time frame: Hourly from PACU arrival to discharge and Q4H from 10:00-22:00 postoperatively for 4 days
Number of Participants With Urinary Retention
Time frame: up to 4 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ali Shariat, MD principal investigator
St. Luke's-Roosevelt Hospital Center
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 Exparel, Bupivacaine HCl with Epinephrine and Normal Saline in people with Hemorrhoid, run by St. Luke's-Roosevelt Hospital Center 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 1 inclusion and 1 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 4 Dec 2018. 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 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?
Yes. Results are posted in the registry (first posted 4 Dec 2018). 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?
Post Operative Pain Control (time frame: up to 4 days). 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 4 Dec 2018.