PainEarly Phase 1NCT03817034
Multimodal Analgesia for the Reduction of Postoperative Opioid Consumption
A Early Phase 1 study testing Multimodal analgesia in people with Pain, run by Massachusetts General Hospital.
Trial summary
The investigators are performing this research study to investigate the efficacy of local infiltration of the surgical wound combining dexmedetomidine, ropivacaine, and ketorolac (treatment group) versus the current standard of care (historical control group), for post-operative pain management. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Pain
- What is being tested?
- Multimodal analgesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 11 Mar 2021to 11 Mar 2021
- Phase
- Early Phase 1
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than 18 years
- American Society of Anesthesiologist Physical Status Classification 1-3
- Undergoing surgery requiring a rectus sheath block
Who cannot join
- American Society of Anesthesiologist Physical Status Classification of 4 or beyond
- history of opiate of illicit substance abuse, chronic pain, or neurological dysfunction
About this study
The investigators are performing this research study to investigate the efficacy of local infiltration of the surgical wound combining dexmedetomidine, ropivacaine, and ketorolac (treatment group) versus the current standard of care (historical control group), for post-operative pain management.
Read the detailed description
During this research study, patients recommended for a rectus sheath block during surgery will receive a novel combination of non-opioid drugs. Data from the treatment group will be compared to surgical outcomes of a historically matched control group to investigate the ability of this drug combination to reduce post-operative pain and post-operative opioid consumption.
- Conditions
- Pain
- Being tested
- Multimodal analgesia
- Keywords
- multimodal, dexmedetomidine, ropivacaine, ketorolac, pain management, opioid sparing, analgesia
- Medical subject headings
- Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal analgesiaDrug
Subjects will be given a rectus sheath block containing dexmedetomidine, ropivacaine, and ketorolac
| Study group | Role | What they receive |
|---|---|---|
| Multimodal Analgesia | Experimental | Not described Receives: Drug: Multimodal analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in post-operative opioid consumption
Decreased post-operative opioid consumption associated with use of multimodal analgesia
Measured: 48 hours
Change in post-operative pain scores
Decreased post-operative pain scores associated with use of multimodal analgesia
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study start11 Mar 2021
- Primary completion11 Mar 2021
- Study completion11 Mar 2021
Why it stopped: We decided to close this study and come up with a new study design.
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 Massachusetts General HospitalThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emery Brown, Massachusetts General Hospital
- Investigators
- Emery N Brown, M.D., Ph.D., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03817034
- Sponsor's protocol ID
- 2018P002053
- Status last verified
- Mar 2021
- First submitted
- 23 Nov 2018
- Last updated
- 1 Apr 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Analgesia for the Reduction of Postoperative Opioid Consumption
- ClinicalTrials.gov ID
- NCT03817034
- Acronym / sponsor ID
- 2018P002053
- Conditions
- Pain
- Keywords
- multimodal, dexmedetomidine, ropivacaine, ketorolac, pain management, opioid sparing, analgesia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We decided to close this study and come up with a new study design.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 11 Mar 2021 (actual)
- Primary completion
- 11 Mar 2021 (actual)
- Study completion
- 11 Mar 2021 (actual)
- First posted
- 25 Jan 2019 (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 investigators are performing this research study to investigate the efficacy of local infiltration of the surgical wound combining dexmedetomidine, ropivacaine, and ketorolac (treatment group) versus the current standard of care (historical control group), for post-operative pain management.
Detailed description
During this research study, patients recommended for a rectus sheath block during surgery will receive a novel combination of non-opioid drugs. Data from the treatment group will be compared to surgical outcomes of a historically matched control group to investigate the ability of this drug combination to reduce post-operative pain and post-operative opioid consumption.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multimodal Analgesia | Experimental | Drug: Multimodal analgesia |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age greater than 18 years
- American Society of Anesthesiologist Physical Status Classification 1-3
- Undergoing surgery requiring a rectus sheath block
Key exclusion criteria (2 listed)
- American Society of Anesthesiologist Physical Status Classification of 4 or beyond
- history of opiate of illicit substance abuse, chronic pain, or neurological dysfunction
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 |
|---|---|---|
| Multimodal analgesiaSubjects will be given a rectus sheath block containing dexmedetomidine, ropivacaine, and ketorolac | Drug | Multimodal Analgesia |
Primary outcome
Change in post-operative opioid consumption
Time frame: 48 hours
Decreased post-operative opioid consumption associated with use of multimodal analgesia
Change in post-operative pain scores
Time frame: 48 hours
Decreased post-operative pain scores associated with use of multimodal analgesia
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 1 Apr 2021.
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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.
Emery N Brown, M.D., Ph.D. principal investigator
Massachusetts General Hospital
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Multimodal analgesia in people with Pain, run by Massachusetts General Hospital.
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 2 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 1 Apr 2021. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Change in post-operative opioid consumption (time frame: 48 hours). The study lists 2 primary outcomes in all. 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 1 Apr 2021; AzTrials last refreshed its copy on 8 Nov 2026.