PainGSopioidsNCT02782884
A Prospective Study of Post-operative Opioid Use in General Surgery Patients
An observational study of Pain, run by Dartmouth-Hitchcock Medical Center.
Trial summary
Patients undergoing approximately 10 common outpatient general surgical operations will be given a narcotic prescription for a specified number of pills. Inpatients who are about to be discharged after surgery or trauma will be given narcotic prescriptions for a specified number of pills. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- Type of treatment
- Pill or oral medicine
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 14 Jun 2016to 16 Aug 2017
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: >= 18 years of age undergoing one of 9 elective outpatient operations: partial mastectomy, partial mastectomy and sentinel node biopsy, melanoma wide excision and sentinel node excision, thyroidectomy, parathyroidectomy, open inguinal hernia repair, laparoscopic inguinal hernia repair, laparoscopic cholecystectomy OR an inpatient on the general surgery service who took at least one oral narcotic in the 24 hrs prior to discharge
Who may be able to join
- >= 18 years of age
- undergoing one of 9 elective outpatient operations: partial mastectomy, partial mastectomy and sentinel node biopsy, melanoma wide excision and sentinel node excision, thyroidectomy, parathyroidectomy, open inguinal hernia repair, laparoscopic inguinal hernia repair, laparoscopic cholecystectomy OR
- an inpatient on the general surgery service who took at least one oral narcotic
Who cannot join
- allergic to all narcotics
- chronic opioid use
- history of opioid or benzodiazepine abuse
About this study
Official title: A Prospective Study of Post-operative Opioid Use in General Surgical Patients
Patients undergoing approximately 10 common outpatient general surgical operations will be given a narcotic prescription for a specified number of pills.
Inpatients who are about to be discharged after surgery or trauma will be given narcotic prescriptions for a specified number of pills. Patients will be given a patient report form which they will use to record the number of pills they take each day and their daily pain score on a scale of 0-10.
- Conditions
- Pain
- Keywords
- post-operative pain
- Medical subject headings
- Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Outpatient general surgery operation | Patients undergoing outpatient general surgical operations They will be given a specified number of narcotic pills based on our retrospective analysis of patient post-operative opioid use | |
| Inpatient general surgical patients | Inpatients who are being discharged They will be given a specified number of narcotic pills based on the number of pills they took in the 24 hrs prior to discharge |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of pills to satisfy 80% of patients opioid needs
Measured: 1 yr
Secondary outcomes (2)
proportion of patients requiring narcotic refills when specified number of pills is given
Measured: 1 year
patient pain level, daily
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2016 (estimated)
- Study start14 Jun 2016
- Primary completion4 Aug 2017
- Study completion16 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard J. Barth,Jr., Dartmouth-Hitchcock Medical Center
- Investigators
- Richard J Barth, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02782884
- Sponsor's protocol ID
- D16112
- Acronym
- GSopioids
- Status last verified
- Jul 2018
- First submitted
- 22 May 2016
- Last updated
- 30 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Post-operative Opioid Use in General Surgical Patients
- ClinicalTrials.gov ID
- NCT02782884
- Acronym / sponsor ID
- GSopioids / D16112
- Conditions
- Pain
- Keywords
- post-operative pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- 14 Jun 2016 (actual)
- Primary completion
- 4 Aug 2017 (actual)
- Study completion
- 16 Aug 2017 (actual)
- First posted
- 25 May 2016 (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.
Patients undergoing approximately 10 common outpatient general surgical operations will be given a narcotic prescription for a specified number of pills.
Inpatients who are about to be discharged after surgery or trauma will be given narcotic prescriptions for a specified number of pills. Patients will be given a patient report form which they will use to record the number of pills they take each day and their daily pain score on a scale of 0-10.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Outpatient general surgery operation | – | –Patients undergoing outpatient general surgical operations They will be given a specified number of narcotic pills based on our retrospective analysis of patient post-operative opioid use |
| Inpatient general surgical patients | – | –Inpatients who are being discharged They will be given a specified number of narcotic pills based on the number of pills they took in the 24 hrs prior to discharge |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- >= 18 years of age undergoing one of 9 elective outpatient operations: partial mastectomy, partial mastectomy and sentinel node biopsy, melanoma wide excision and sentinel node excision, thyroidectomy, parathyroidectomy, open inguinal hernia repair, laparoscopic inguinal hernia repair, laparoscopic cholecystectomy OR an inpatient on the general surgery service who took at least one oral narcotic in the 24 hrs prior to discharge
Key inclusion criteria (3 listed)
- >= 18 years of age
- undergoing one of 9 elective outpatient operations: partial mastectomy, partial mastectomy and sentinel node biopsy, melanoma wide excision and sentinel node excision, thyroidectomy, parathyroidectomy, open inguinal hernia repair, laparoscopic inguinal hernia repair, laparoscopic cholecystectomy OR
- an inpatient on the general surgery service who took at least one oral narcotic
Key exclusion criteria (3 listed)
- allergic to all narcotics
- chronic opioid use
- history of opioid or benzodiazepine abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
number of pills to satisfy 80% of patients opioid needs
Time frame: 1 yr
2 secondary outcomes
proportion of patients requiring narcotic refills when specified number of pills is given
Time frame: 1 year
patient pain level, daily
Time frame: 1 year
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 30 Jul 2018.
- Individual participant dataSharing planned: No
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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.
Richard J Barth, MD principal investigator
Dartmouth-Hitchcock Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, run by Dartmouth-Hitchcock Medical Center.
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 3 inclusion and 3 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 30 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
number of pills to satisfy 80% of patients opioid needs (time frame: 1 yr). 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 30 Jul 2018; AzTrials last refreshed its copy on 6 Nov 2026.