Narcotic UsePhase 4PainNCT02110719
Decreasing Narcotics in Advanced Pelvic Surgery
A Phase 4 study testing Celebrex, Gabapentin and IV acetaminophen in people with Narcotic Use and Pain, run by Hartford Hospital at 1 site in United States.
Trial summary
In recent years, there has been an emphasis on the creation of "enhanced-recovery", "fast-track" or "multi-modal" pathways to improve perioperative care (1-4). The goal of these programs is to reduce the length of hospital stay, decrease narcotic usage while improving pain control, accelerate post-operative recovery… Read more about this study
- Who is it for?
- Ages 18 to 100 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Narcotic Use, Pain, Constipation
- What is being tested?
- Celebrex, Gabapentin and IV acetaminophen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Jun 2016
- Phase
- Phase 4
- 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 100 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- women >/= 18 years old
- undergoing pelvic organ prolapse or incontinence surgery with the Urogynecology department
Who cannot join
- males
- <18 years old
- women unwilling or unable to consent
- same-day-discharge surgery
- history of chronic pain for which they use medications
- current or active history of narcotic abuse
Show all 9Show fewer
- sleep apnea
- liver or kidney dysfunction
- sulfa allergy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Decreasing Narcotics in Advanced Pelvic Surgery: A Randomized Study
In recent years, there has been an emphasis on the creation of "enhanced-recovery", "fast-track" or "multi-modal" pathways to improve perioperative care (1-4). The goal of these programs is to reduce the length of hospital stay, decrease narcotic usage while improving pain control, accelerate post-operative recovery, and expedite return to baseline functional status. Pathways often are developed by a team of surgeons, nurses, pain specialists, anesthesiologists and other support staff. Postoperative components often involve multi-modal analgesia, early return to activity and early return to a regular diet. The goal of this study is to evaluate the efficacy of a multi-modal pain regimen in advanced pelvic surgery with a primary goal of decreasing narcotic usage.
- Conditions
- Narcotic Use, Pain, Constipation, Nausea
- Being tested
- Celebrex, Gabapentin, IV acetaminophen, oral acetaminophen, oral ibuprofen
- Keywords
- narcotic use, pain, constipation, nausea
- Medical subject headings
- Pain, Constipation, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelebrexDrug
GabapentinDrug
IV acetaminophenDrug
oral acetaminophenDrug
oral ibuprofenDrug
percocetDrug
vicodinDrug
OxycodoneDrug
dilaudidDrug
DexamethasoneDrug
zofranDrug
| Study group | Role | What they receive |
|---|---|---|
| Standard | Active comparator | Patients will be given the following:
* no preoperative medications
* intraoperative medications per anesthesia
* postoperatively, patients will receive ibuprofen, tylenol and narcotics as needed Receives: Drug: oral acetaminophen; Drug: oral ibuprofen; Drug: percocet; Drug: vicodin; Drug: dilaudid |
| Multimodal | Active comparator | Patients in the multimodal arm will receive the following:
* preoperative celebrex and gabapentin
* intraoperative IV acetaminophen, dexamethasone, zofran
* postoperative scheduled IV acetaminophen, PO celebrex and gabapentin, and as needed PO narcotics
* patient will be discharged on scheduled ibuprofen and acetaminophen for 3 days followed by "as needed" use as well as "as needed" narcotics Receives: Drug: Celebrex; Drug: Gabapentin; Drug: IV acetaminophen; Drug: oral acetaminophen; Drug: oral ibuprofen; Drug: Oxycodone; Drug: dilaudid; Drug: Dexamethasone; Drug: zofran |
What is being measured
The primary outcome is the main question the study is designed to answer.
Narcotic use
Narcotic use will be evaluated at all stages of the preoperative care: operating room, hospital floor and at the 1 week postoperative time point
Measured: intraoperative, immediate postoperative and 1 week postoperative
Secondary outcomes (3)
Pain
pain will be evaluated at the above listed time points using the validated brief pain inventory
Measured: postoperative day #1 and postoperative week #1
Nausea
Nausea will be evaluated based on the use of narcotics in the hospital
Measured: intraoperatively, postoperatively
Constipation
constipation at the time of the first bowel movement will be evaluated using the validated Bristol Stool Scale
Measured: one week postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionJul 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Narcotic UseStudies 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
- None (open label)
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hartford Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Krista Reagan, MD, Principal investigator, Hartford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02110719
- Sponsor's protocol ID
- REAG00414HU
- Acronym
- Pain
- Status last verified
- Aug 2016
- First submitted
- 7 Apr 2014
- Last updated
- 17 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decreasing Narcotics in Advanced Pelvic Surgery: A Randomized Study
- ClinicalTrials.gov ID
- NCT02110719
- Acronym / sponsor ID
- Pain / REAG00414HU
- Conditions
- Narcotic Use, Pain, Constipation, Nausea
- Keywords
- narcotic use, pain, constipation, nausea
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Hartford HospitalUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 10 Apr 2014 (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.
In recent years, there has been an emphasis on the creation of "enhanced-recovery", "fast-track" or "multi-modal" pathways to improve perioperative care (1-4). The goal of these programs is to reduce the length of hospital stay, decrease narcotic usage while improving pain control, accelerate post-operative recovery, and expedite return to baseline functional status. Pathways often are developed by a team of surgeons, nurses, pain specialists, anesthesiologists and other support staff. Postoperative components often involve multi-modal analgesia, early return to activity and early return to a regular diet. The goal of this study is to evaluate the efficacy of a multi-modal pain regimen in advanced pelvic surgery with a primary goal of decreasing narcotic usage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard | Active comparator | Drug: oral acetaminophen, Drug: oral ibuprofen, Drug: percocet, Drug: vicodin, Drug: dilaudidPatients will be given the following: * no preoperative medications * intraoperative medications per anesthesia * postoperatively, patients will receive ibuprofen, tylenol and narcotics as needed |
| Multimodal | Active comparator | Drug: Celebrex, Drug: Gabapentin, Drug: IV acetaminophen, Drug: oral acetaminophen, Drug: oral ibuprofen, Drug: Oxycodone, Drug: dilaudid, Drug: Dexamethasone, Drug: zofranPatients in the multimodal arm will receive the following: * preoperative celebrex and gabapentin * intraoperative IV acetaminophen, dexamethasone, zofran * postoperative scheduled IV acetaminophen, PO celebrex and gabapentin, and as needed PO narcotics * patient will be discharged on scheduled ibuprofen and acetaminophen for 3 days followed by "as needed" use as well as "as needed" narcotics |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- women >/= 18 years old
- undergoing pelvic organ prolapse or incontinence surgery with the Urogynecology department
Key exclusion criteria (9 listed)
- males
- <18 years old
- women unwilling or unable to consent
- same-day-discharge surgery
- history of chronic pain for which they use medications
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 |
|---|---|---|
| Celebrex | Drug | Multimodal |
| Gabapentin | Drug | Multimodal |
| IV acetaminophen | Drug | Multimodal |
| oral acetaminophen | Drug | Multimodal, Standard |
| oral ibuprofen | Drug | Multimodal, Standard |
| percocet | Drug | Standard |
| vicodin | Drug | Standard |
| Oxycodone | Drug | Multimodal |
| dilaudid | Drug | Multimodal, Standard |
| Dexamethasone | Drug | Multimodal |
| zofran | Drug | Multimodal |
Primary outcome
Narcotic use
Time frame: intraoperative, immediate postoperative and 1 week postoperative
Narcotic use will be evaluated at all stages of the preoperative care: operating room, hospital floor and at the 1 week postoperative time point
3 secondary outcomes
Pain
Time frame: postoperative day #1 and postoperative week #1
Nausea
Time frame: intraoperatively, postoperatively
Constipation
Time frame: one week postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2016.
- Individual participant dataSharing planned: No
Related trials for Narcotic Use
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
RecruitingPhase 4
Nonopioid Pain Control Regimen After Open Reduction and Internal Fixation of Traumatic Fractures
Opioid Use, Fractures, Bone
Enrolling by invitation
PATH to Reducing Burnout Among Peers Who Deliver Overdose Prevention Services (R33 Phase Clinical Trial)
Burnout, Secondary Trauma
Not yet recruiting
Real World Evaluation of the Effectiveness and Implementation of a Digital Health Therapeutic for OUD
Opioid Use Disorder
Not yet recruitingEarly Phase 1
Pain Sensitivity, Alcohol-Induced Analgesia, and Heavy Drinking in Individuals With Opioid Use Disorder
Opioid Use Disorder, Alcohol Intoxication
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.
Krista Reagan, MD principal investigator
Hartford Hospital
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 Celebrex, Gabapentin and IV acetaminophen in people with Narcotic Use and Pain, run by Hartford Hospital 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 2 inclusion and 9 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: finished, as of the sponsor's last update on 17 Aug 2016. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Narcotic use (time frame: intraoperative, immediate postoperative and 1 week postoperative). 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 17 Aug 2016.