Chronic PainPhase 1NCT02940509
Ketamine and Magnesium in Post-operative Pain Control in Patients Treated With Opioids
A Phase 1 study testing Ketamine plus Magnesium sulfate in people with Chronic Pain, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
The goal of this research proposal is to determine if the intraoperative administrative of Ketamine and Magnesium during laparoscopic gynecologic surgery improves postoperative pain in patients on chronic opioid therapy for management of chronic pelvic pain. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Ketamine plus Magnesium sulfate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2017to 27 Feb 2018
- Phase
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects undergoing elective laparoscopic gynecologic surgery
- Patients with chronic pelvic pain defined as pain that has persisted for more than 6 months in duration which is localized to the pelvis, anterior abdominal wall, lower back or buttocks and has leads to functional disability or medical care1
- Patients requiring opioids daily for >1 month
- Consenting adults age 18-80
- American Society of Anesthesiologists (ASA) Physical Status classification II to ASA III
Who cannot join
- Patient refusal
- Chronic Kidney disease (Creatinine>2)
- Patients treated with methadone
- Known allergy or adverse effect of ketamine or magnesium
- Patient unable to give informed consent
- Patient with limited or no English fluency
- Uncontrolled hypertension
Trial locations and contacts
1 site in 1 country.
United States1 site
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: The Role of Ketamine and Magnesium in Post-operative Pain Control After Laparoscopic Surgery in Patients With Chronic Pelvic Pain Treated With Opioids: A Double-Blinded Randomized Control Trial.
The goal of this research proposal is to determine if the intraoperative administrative of Ketamine and Magnesium during laparoscopic gynecologic surgery improves postoperative pain in patients on chronic opioid therapy for management of chronic pelvic pain.
Read the detailed description
In this randomized control trial, patients' postoperative pain scores will be assessed as scored by the Numeric Rating Score (NRS) system. Intraoperative and postoperative narcotic usage, nausea scores and patients' perception of their quality of recovery via the QoR-40 survey will also be assessed.
The use of intraoperative Ketamine and Magnesium is predicted to decrease postoperative pain in patients on chronic opioid therapy for management of chronic pelvic pain and will overall improve patients' postoperative experience.
- Conditions
- Chronic Pain
- Being tested
- Ketamine plus Magnesium sulfate, Placebo
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine plus Magnesium sulfateDrug
Patients will receive 2 IV infusions:
- Ketamine (0.5mg/kg)
- Magnesium sulfate (2g)
PlaceboDrug
Also called 2 placebo infusions
Patients will receive 2 IV infusions, both of NaCl 0.9%, as placebos for Ketamine and magnesium sulfate
| Study group | Role | What they receive |
|---|---|---|
| Ketamine plus Magnesium sulfate | Active comparator | Ketamine 0.5mg/kg IV dose with 2g magnesium IV dose Receives: Drug: Ketamine plus Magnesium sulfate |
| Placebo | Placebo comparator | Normal Saline (NaCl 0.9%) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain score using the Numeric Rating Scale (NRS)
Patient described pain level on a scale of 0-10
Measured: 1st 24 hours post-op
Secondary outcomes (5)
Post-operative opioid use
Dilaudid and Oxycodone in mg.
Measured: 24 hours post operative
Recovery Questionnaire
Patient perception of quality of recovery as measured by the QoR-40 Survey
Measured: 3-5 days post operative
Intraoperative fentanyl use
Amount of fentanyl used intra-operatively in mcg.
Measured: Intraoperative
Nausea Scores using PONV Impact Scale Score
Patient described nausea level using 2 questions each with 4 answers with numerical value from 0-3. To calculate the PONV Impact Scale score, the numerical responses to questions 1 and 2 are added to obtain the PONV impact scale score. A PONV Impact Scale score of ≥5 defines clinically important PONV.
Measured: 24 hours Post operative
Length of Hospital Stay
Number of days the patient was an inpatient in the hospital.
Measured: 24 hours Post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2016 (estimated)
- Study start1 Jul 2017
- Primary completion27 Feb 2018
- Study completion27 Feb 2018
Why it stopped: Change in practice of medicine. There were no longer sufficient patients to enroll in the study that met criteria.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stacey Duryea, Milton S. Hershey Medical Center
- Investigators
- Stacey Duryea, DO, Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02940509
- Sponsor's protocol ID
- STUDY00006048
- Status last verified
- May 2022
- First submitted
- 18 Oct 2016
- Last updated
- 27 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Ketamine and Magnesium in Post-operative Pain Control After Laparoscopic Surgery in Patients With Chronic Pelvic Pain Treated With Opioids: A Double-Blinded Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT02940509
- Acronym / sponsor ID
- STUDY00006048
- Conditions
- Chronic Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Change in practice of medicine. There were no longer sufficient patients to enroll in the study that met criteria.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 27 Feb 2018 (actual)
- Study completion
- 27 Feb 2018 (actual)
- First posted
- 21 Oct 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.
The goal of this research proposal is to determine if the intraoperative administrative of Ketamine and Magnesium during laparoscopic gynecologic surgery improves postoperative pain in patients on chronic opioid therapy for management of chronic pelvic pain.
Detailed description
In this randomized control trial, patients' postoperative pain scores will be assessed as scored by the Numeric Rating Score (NRS) system. Intraoperative and postoperative narcotic usage, nausea scores and patients' perception of their quality of recovery via the QoR-40 survey will also be assessed.
The use of intraoperative Ketamine and Magnesium is predicted to decrease postoperative pain in patients on chronic opioid therapy for management of chronic pelvic pain and will overall improve patients' postoperative experience.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine plus Magnesium sulfate | Active comparator | Drug: Ketamine plus Magnesium sulfateKetamine 0.5mg/kg IV dose with 2g magnesium IV dose |
| Placebo | Placebo comparator | Drug: PlaceboNormal Saline (NaCl 0.9%) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects undergoing elective laparoscopic gynecologic surgery
- Patients with chronic pelvic pain defined as pain that has persisted for more than 6 months in duration which is localized to the pelvis, anterior abdominal wall, lower back or buttocks and has leads to functional disability or medical care1
- Patients requiring opioids daily for >1 month
- Consenting adults age 18-80
- American Society of Anesthesiologists (ASA) Physical Status classification II to ASA III
Key exclusion criteria (7 listed)
- Patient refusal
- Chronic Kidney disease (Creatinine>2)
- Patients treated with methadone
- Known allergy or adverse effect of ketamine or magnesium
- Patient unable to give informed consent
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 |
|---|---|---|
| Ketamine plus Magnesium sulfatePatients will receive 2 IV infusions: 1. Ketamine (0.5mg/kg) 2. Magnesium sulfate (2g) | Drug | Ketamine plus Magnesium sulfate |
| PlaceboAlso: 2 placebo infusionsPatients will receive 2 IV infusions, both of NaCl 0.9%, as placebos for Ketamine and magnesium sulfate | Drug | Placebo |
Primary outcome
Post-operative pain score using the Numeric Rating Scale (NRS)
Time frame: 1st 24 hours post-op
Patient described pain level on a scale of 0-10
5 secondary outcomes
Post-operative opioid use
Time frame: 24 hours post operative
Recovery Questionnaire
Time frame: 3-5 days post operative
Intraoperative fentanyl use
Time frame: Intraoperative
Nausea Scores using PONV Impact Scale Score
Time frame: 24 hours Post operative
Length of Hospital Stay
Time frame: 24 hours Post operative
Results and safety
The study was stopped early (reason given: Change in practice of medicine. There were no longer sufficient patients to enroll in the study that met criteria.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
- Individual participant dataSharing planned: No
Related trials for Chronic Pain
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
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.
Stacey Duryea, DO principal investigator
Milton S. Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ketamine plus Magnesium sulfate in people with Chronic Pain, run by Milton S. Hershey Medical 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 5 inclusion and 7 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 27 May 2022. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 stopped early (reason given: Change in practice of medicine. There were no longer sufficient patients to enroll in the study that met criteria.). Results are not available in the source record.
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 score using the Numeric Rating Scale (NRS) (time frame: 1st 24 hours post-op). 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 27 May 2022.