ThoracicPhase 3NCT05100160
Gabapentin for the Reduction of Opiate Use Following Pulmonary Resection (GROUP Trial)
A Phase 3 study testing Gabapentin in people with Thoracic and Pulmonary Disease, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The aim of this study is to determine if the reduction in narcotic requirement following pulmonary resection with gabapentin is clinically significant when compared to the effect seen with placebo. We have defined clinically meaningful as a reduction by 30 Morphine equivalent doses (MED) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic, Pulmonary Disease
- What is being tested?
- Gabapentin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2021to 3 Jan 2023
- Phase
- Phase 3
- 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
Who may be able to join
- Age 18+
- Undergoing pulmonary resection (includes metastasectomy as well as anatomic resections)
- Must have device with email capabilities for follow up survey
Who cannot join
- Requiring narcotic pain medication or Gabapentin at the time of preoperative appointment or within 30 days of surgery
- Renal impairment requiring dialysis
- Allergy to Gabapentin
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to determine if the reduction in narcotic requirement following pulmonary resection with gabapentin is clinically significant when compared to the effect seen with placebo. We have defined clinically meaningful as a reduction by 30 Morphine equivalent doses (MED)
Read the detailed description
Study Objectives:
The aim of this study is to determine if the reduction in narcotic requirement following pulmonary resection with gabapentin is clinically significant when compared to the effect seen with placebo. We have defined clinically meaningful as a reduction by 25% Morphine equivalent doses (MED) Secondary objectives are to evaluate the utility of gabapentin in reducing postoperative pain, reducing hospital length of stay, promoting faster return to baseline function (to be assessed by MDASI), preventing post thoracotomy pain syndrome (to be assessed by BPI), and reducing the rate of chronic opiate use among patients undergoing thoracic procedures.
- Primary Endpoint The primary outcome will be the sum of the daily average morphine equivalent dose of opioids recorded from day of surgery (day 0) through 7 days after surgery, for a total of 8 days.
- Secondary Endpoints
- Time to resuming normal activities
- Presence/absence of chronic pain at 3 and 6 months, measured by BPI
- 30, 90, 180 day opiate use (Y/N)
- MDASI on post-operative days 7, 30, 90, 180
- Basic Pain Inventory (BPI) on post-operative days 1,2, 7, 30, 90, 180
- Daily pain score during hospitalization
- Length of hospital stay
- Need for opioids at discharge
- Whether medication is stopped prior to day 25, and if so when and for what reason.
- Conditions
- Thoracic, Pulmonary Disease
- Being tested
- Gabapentin, Placebo
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
Given by PO
PlaceboOther
Given by PO
| Study group | Role | What they receive |
|---|---|---|
| Gabapentin | Experimental | used as part of a multimodal pain regimen (combination of drugs used to control pain Receives: Drug: Gabapentin |
| Placebo | Experimental | designed to be compared with a study drug to learn if the study drug has any real effect Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in narcotic requirement following pulmonary resection with gabapentin is clinically significant when compared to the effect seen with placebo
The sum of the daily average morphine equivalent dose of opioids recorded from day of surgery (day 0) through 7 days after surgery, for a total of 8 days
Measured: through study completion, up to 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start15 Sep 2021
- Primary completion3 Jan 2023
- Study completion3 Jan 2023
Why it stopped: 0 patient accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThoracicStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Rice, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05100160
- Sponsor's protocol ID
- 2021-0653
- Other IDs
- NCI-2021-10727
- Status last verified
- Apr 2023
- First submitted
- 22 Sep 2021
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gabapentin for the Reduction of Opiate Use Following Pulmonary Resection (GROUP Trial)
- ClinicalTrials.gov ID
- NCT05100160
- Acronym / sponsor ID
- 2021-0653
- Conditions
- Thoracic, Pulmonary Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: 0 patient accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 3 Jan 2023 (actual)
- Study completion
- 3 Jan 2023 (actual)
- First posted
- 29 Oct 2021 (actual)
- 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.
The aim of this study is to determine if the reduction in narcotic requirement following pulmonary resection with gabapentin is clinically significant when compared to the effect seen with placebo. We have defined clinically meaningful as a reduction by 30 Morphine equivalent doses (MED)
Detailed description
Study Objectives:
The aim of this study is to determine if the reduction in narcotic requirement following pulmonary resection with gabapentin is clinically significant when compared to the effect seen with placebo. We have defined clinically meaningful as a reduction by 25% Morphine equivalent doses (MED) Secondary objectives are to evaluate the utility of gabapentin in reducing postoperative pain, reducing hospital length of stay, promoting faster return to baseline function (to be assessed by MDASI), preventing post thoracotomy pain syndrome (to be assessed by BPI), and reducing the rate of chronic opiate use among patients undergoing thoracic procedures.
- Primary Endpoint The primary outcome will be the sum of the daily average morphine equivalent dose of opioids recorded from day of surgery (day 0) through 7 days after surgery, for a total of 8 days.
- Secondary Endpoints
- Time to resuming normal activities
- Presence/absence of chronic pain at 3 and 6 months, measured by BPI
- 30, 90, 180 day opiate use (Y/N)
- MDASI on post-operative days 7, 30, 90, 180
- Basic Pain Inventory (BPI) on post-operative days 1,2, 7, 30, 90, 180
- Daily pain score during hospitalization
- Length of hospital stay
- Need for opioids at discharge
- Whether medication is stopped prior to day 25, and if so when and for what reason.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gabapentin | Experimental | Drug: Gabapentinused as part of a multimodal pain regimen (combination of drugs used to control pain |
| Placebo | Experimental | Other: Placebodesigned to be compared with a study drug to learn if the study drug has any real effect |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18+
- Undergoing pulmonary resection (includes metastasectomy as well as anatomic resections)
- Must have device with email capabilities for follow up survey
Key exclusion criteria (3 listed)
- Requiring narcotic pain medication or Gabapentin at the time of preoperative appointment or within 30 days of surgery
- Renal impairment requiring dialysis
- Allergy to Gabapentin
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 |
|---|---|---|
| GabapentinGiven by PO | Drug | Gabapentin |
| PlaceboGiven by PO | Other | Placebo |
Primary outcome
The change in narcotic requirement following pulmonary resection with gabapentin is clinically significant when compared to the effect seen with placebo
Time frame: through study completion, up to 8 days
The sum of the daily average morphine equivalent dose of opioids recorded from day of surgery (day 0) through 7 days after surgery, for a total of 8 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- M D Anderson Cancer CenterLink provided by the sponsor.
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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.
David Rice principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gabapentin in people with Thoracic and Pulmonary Disease, run by M.D. Anderson Cancer 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 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: withdrawn, as of the sponsor's last update on 13 Apr 2023. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was withdrawn before enrolling participants, so there are no results.
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?
The change in narcotic requirement following pulmonary resection with gabapentin is clinically significant when compared to the effect seen with placebo (time frame: through study completion, up to 8 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 13 Apr 2023; AzTrials last refreshed its copy on 8 Nov 2026.