Labor PainNCT01146457
The Optimal Dosage of Intrathecal Morphine for Peripartum Analgesia
A study testing Morphine and Saline in people with Labor Pain, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine the ideal dosage of intrathecal morphine for intra and post partum analgesia, while minimizing the side effect profile. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Labor Pain
- What is being tested?
- Morphine and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Jan 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- singleton pregnancy,
- at least 36 weeks gestational age,
- active labor (≤ 5 cm dilation) requesting neuraxial analgesia,
- ASA I or II,
- not currently taking pain medications.
Who cannot join
- multiple gestation,
- preterm labor,
- systemic opioids in the past 4 hours,
- chronic pain syndromes,
- chronic opioid use,
- contraindications to regional anesthesia,
Show all 12Show fewer
- allergies to opioids,
- significant co existing medical problems,
- severe pregnancy induced hypertension,
- sedatives,
- magnesium therapy,
- diabetes type 1.
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
The purpose of this study is to determine the ideal dosage of intrathecal morphine for intra and post partum analgesia, while minimizing the side effect profile.
Read the detailed description
Regional anesthesia techniques such as combined spinal epidural (CSE) analgesia are very effective for the management of intrapartum pain. The advantages of these techniques are that they are safe when properly conducted and that they provide excellent analgesia while allowing the patient to remain awake and participate in the labor and delivery. The risks of maternal aspiration and fetal drug depression associated with general anesthesia are minimized. Finally, the effective analgesia associated with regional techniques blunt the hemodynamic effects caused by painful contractions and reduce maternal catecholamines, resulting in increased placental perfusion.1
Opioids in combination with local anesthetics in the spinal space provide effective pain relief during labor with minimal side effects. The advantages of spinal opioid administration include lack of motor blockade and faster onset of analgesia.2 In addition, since the opiate receptors are in the spinal space, a smaller amount of opioid can be used to provide excellent pain relief while minimizing the side effects. At Beth Israel Deaconess Medical Center (BIDMC), the obstetric anesthesiology group uses a standard spinal dosing for CSE during labor which includes: 1 ml of 0.25% bupivicaine with 12.5 mcg of fentanyl.
Yeh and colleagues have found that morphine 150 mcg added to the fentanyl-bupivicaine spinal injection can prolong the duration of spinal analgesia but was associated with increased side effects. 3 The side effect profile of spinal narcotics include: nausea, vomiting, pruritus, and urinary retention. Although these side effects for the most part can be easily treated, they can be bothersome to the post partum patient. In a previous study performed from our institution, the addition of 100 mcg of morphine to spinal bupivicaine and fentanyl reduced the rate of breakthrough pain during labor analgesia and prolonged the time to first request for supplementation. Overall, it was found that the incidence of side effects was low but the group that received the spinal morphine did have more nausea and vomiting compared with the placebo group. 4
In this current investigation, we would like to assess whether an even smaller dose of spinal morphine would provide an effective, pain free recovery from vaginal delivery while decreasing the incidence of side effects, specifically nausea and vomiting. We would like to perform a formal dose response study to identify the ideal dose of intrathecal morphine that would not compromise the pain relief during labor while minimizing the side effects.
- Conditions
- Labor Pain
- Being tested
- Morphine, Saline
- Keywords
- Obstetric anesthesia, labor analgesia, morphine, epidural analgesia
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MorphineDrug
Also called Dose of morphine added to solution
Active dosage
SalineDrug
Also called Saline added to solution
Saline Control
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Saline |
| Morphine 25 | Active comparator | Not described Receives: Drug: Morphine |
| Morphine 50 | Active comparator | Not described Receives: Drug: Morphine |
| Morphine 75 | Active comparator | Not described Receives: Drug: Morphine |
| Morphine 100 | Active comparator | Not described Receives: Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Breakthrough Pain
Rate of breakthrough pain is the number of episodes of breakthrough pain divided by the number of hours of labor. Time measured from placement of the neuraxial anesthetic, until delivery of the neonate. Because duration of labor is different for all patients, the rate of breakthrough pain per hour is used as the primary outcome.
Measured: Participants were followed for the duration of delivery, an average of 7 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2010 (estimated)
- Study startJul 2010
- Primary completionJan 2015
- Study completionJan 2015
Why it stopped: Principal Investigator
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Labor PainStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Phillip Hess, Beth Israel Deaconess Medical Center
- Investigators
- Philip E Hess, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01146457
- Sponsor's protocol ID
- 2009P000197
- Status last verified
- Mar 2017
- First submitted
- 14 Jun 2010
- Last updated
- 25 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Optimal Dosage of Intrathecal Morphine for Peripartum Analgesia
- ClinicalTrials.gov ID
- NCT01146457
- Acronym / sponsor ID
- 2009P000197
- Conditions
- Labor Pain
- Keywords
- Obstetric anesthesia, labor analgesia, morphine, epidural analgesia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Principal Investigator
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 17 Jun 2010 (estimated)
- Results
- Posted 25 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the ideal dosage of intrathecal morphine for intra and post partum analgesia, while minimizing the side effect profile.
Detailed description
Regional anesthesia techniques such as combined spinal epidural (CSE) analgesia are very effective for the management of intrapartum pain. The advantages of these techniques are that they are safe when properly conducted and that they provide excellent analgesia while allowing the patient to remain awake and participate in the labor and delivery. The risks of maternal aspiration and fetal drug depression associated with general anesthesia are minimized. Finally, the effective analgesia associated with regional techniques blunt the hemodynamic effects caused by painful contractions and reduce maternal catecholamines, resulting in increased placental perfusion.1
Opioids in combination with local anesthetics in the spinal space provide effective pain relief during labor with minimal side effects. The advantages of spinal opioid administration include lack of motor blockade and faster onset of analgesia.2 In addition, since the opiate receptors are in the spinal space, a smaller amount of opioid can be used to provide excellent pain relief while minimizing the side effects. At Beth Israel Deaconess Medical Center (BIDMC), the obstetric anesthesiology group uses a standard spinal dosing for CSE during labor which includes: 1 ml of 0.25% bupivicaine with 12.5 mcg of fentanyl.
Yeh and colleagues have found that morphine 150 mcg added to the fentanyl-bupivicaine spinal injection can prolong the duration of spinal analgesia but was associated with increased side effects. 3 The side effect profile of spinal narcotics include: nausea, vomiting, pruritus, and urinary retention. Although these side effects for the most part can be easily treated, they can be bothersome to the post partum patient. In a previous study performed from our institution, the addition of 100 mcg of morphine to spinal bupivicaine and fentanyl reduced the rate of breakthrough pain during labor analgesia and prolonged the time to first request for supplementation. Overall, it was found that the incidence of side effects was low but the group that received the spinal morphine did have more nausea and vomiting compared with the placebo group. 4
In this current investigation, we would like to assess whether an even smaller dose of spinal morphine would provide an effective, pain free recovery from vaginal delivery while decreasing the incidence of side effects, specifically nausea and vomiting. We would like to perform a formal dose response study to identify the ideal dose of intrathecal morphine that would not compromise the pain relief during labor while minimizing the side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Saline |
| Morphine 25 | Active comparator | Drug: Morphine |
| Morphine 50 | Active comparator | Drug: Morphine |
| Morphine 75 | Active comparator | Drug: Morphine |
| Morphine 100 | Active comparator | Drug: Morphine |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- singleton pregnancy,
- at least 36 weeks gestational age,
- active labor (≤ 5 cm dilation) requesting neuraxial analgesia,
- ASA I or II,
- not currently taking pain medications.
Key exclusion criteria (12 listed)
- multiple gestation,
- preterm labor,
- systemic opioids in the past 4 hours,
- chronic pain syndromes,
- chronic opioid use,
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 |
|---|---|---|
| MorphineAlso: Dose of morphine added to solutionActive dosage | Drug | Morphine 100, Morphine 25, Morphine 50, Morphine 75 |
| SalineAlso: Saline added to solutionSaline Control | Drug | Placebo |
Primary outcome
Rate of Breakthrough Pain
Time frame: Participants were followed for the duration of delivery, an average of 7 hours
Rate of breakthrough pain is the number of episodes of breakthrough pain divided by the number of hours of labor. Time measured from placement of the neuraxial anesthetic, until delivery of the neonate. Because duration of labor is different for all patients, the rate of breakthrough pain per hour is used as the primary outcome.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Labor Pain
Recruiting
The Effect Of Partner-Assısted Rebozo Technıque On Labor Paın And Satısfactıon In Prımary Pregnant Women
Labor Pains
RecruitingPhase 4
Analgesic Efficacy and Obstetric Effects of Tramadol, Paracetamol and Placebo in Active Labor
Labor Pain
Not yet recruiting
Pre-Examination Reflexology for Anxiety and Pain During Pelvic Examination
Anxiety
Recruiting
Pain Neuroscience-Based Education for Labor Pain in Pregnant Women
Labor Pain and Anxiety
Recruiting
The Effect of Breast Milk, 10% and 20% Dextrose on Pain and Physiological Variables During Heel Puncture in Infants
Newborn Care, Pain Management
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.
Philip E Hess, MD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Morphine and Saline in people with Labor Pain, run by Beth Israel Deaconess 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 12 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 25 Apr 2017. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Rate of Breakthrough Pain (time frame: Participants were followed for the duration of delivery, an average of 7 hours). 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 25 Apr 2017.