Labor PainPhase 3IMINCT04887649
Randomized, Controlled, Double Blind, to Evaluate the Postpartum Analgesia With Epidural Morphine: Analgesic Effect of Two Different Doses Compared to Placebo
A Phase 3 study testing Morphine and saline solution in people with Labor Pain, run by Universidad Nacional de Colombia at 1 site in Colombia.
Trial summary
This study aims to assess the analgesic effect of two different doses of epidural morphine for postpartum analgesia management. Previous studies have shown that conventional management of postpartum pain (acetaminophen, NSAIDs) is insufficient, in the investigators country is wasted using the epidural catheter is… Read more about this study
- Who is it for?
- Ages 14 to 40 years, women only
- Conditions the study is for
- Labor Pain
- What is being tested?
- Morphine and saline solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 1 siteColombia
- Study dates
- Mar 2009to Apr 2011
- 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 14 to 40 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients postpartum vaginal conventional analgesia management of your labor
- ASA II
- Do not include patients with history of allergy to morphine.
- Patients who agreed to be included in the study but did not sign informed consent.
Who cannot join
- Submit a complication that makes it difficult postoperative pain assessment or adverse effects after surgery.
- Patients who, after having been included, express their desire to be excluded. Patients with incomplete follow-up.id
- Did not include patients who have absolute contraindications for epidural anesthesia, or could not provide informed consent, as in the following cases: local infection at the site of administration, systemic infection, bleeding disorders, disease of the spine , mental patients, drug history, sleep apnea, history of headache post-puncture headache or frequent any kind.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to assess the analgesic effect of two different doses of epidural morphine for postpartum analgesia management. Previous studies have shown that conventional management of postpartum pain (acetaminophen, NSAIDs) is insufficient, in the investigators country is wasted using the epidural catheter is placed as part of the analgesic management of pregnant women in labor.
Read the detailed description
The intervention is the epidural administration of morphine in two doses 2mg and 3mg different vs placebo 1 hour after delivery care maternal vaginal in patients who received epidural analgesia in labor, in order to evaluate the analgesic effectiveness post operations of the different doses vs placebo.
In the analysis to determine whether the proposed levels are effective for postpartum pain control was carried out by determining the differences between experimental groups and control group, and in examining the statistical significance of the differences found by applying the relevant tests according to whether the variable is normally distributed or not.
The main variables analyzed were:
rating of pain intensity, number of analgesics required required dose of analgesics used to achieve adequate control pain, number of pain episodes and percentage of patients free of these episodes, duration of action of the dose used.
Similar analysis was determined by the incidence of side effects, in particular those described in classic form, pruritus, nausea and vomiting, urinary retention, and respiratory depression
Were classified into three groups: two experimental and one control group.
Experimental Group 1 will receive 10 ml of solution prepared as follows:
2 mg of morphine diluted in 0.9% normal saline
Experimental Group 2 will receive 10 ml of solution prepared as follows:
3 mg of morphine diluted in 0.9% normal saline
The control group will receive 10 ml of normal saline (SSN).
The randomization codes were kept in a sealed envelope so individual, and the envelopes were guarded and uncovered after a eligible to participate in the study agreed to be included and signed the informed consent.
Anesthesia Technique for the Study
In ASA II patients in labor who were initiates of labor analgesia with epidural catheter has been placed ideally at the level of L3-L4 (Tuohy catheter conventional number 18, introduced by loss of resistance technique) .
The patients were started a conventional dose of analgesia with bupivacaine 0.5% + fentanyl 100mcg 10mg 10cc carried in a bolus. Administered bupivacaine + 10 mg bolus of fentanyl 100mcg as needed to strengthen the epidural analgesia
or Infusion Bupivacaine 0.125% + Fentanyl 100mcg%
In a 10cc bolus then 8-16CC hours
In patients 1 hour after having her expulsive morphine were previously applied in laboratory and packaged in disregard of the anesthesiologist applied morphine 2mg - 3mg or saline placebo.
The dose will be applied 1 hour after birth in search of having no residual analgesic effect of local anesthetic and opioid epidural analgesia initially applied.
All patients will be managed with conventional analgesia performed in the institution acetaminophen 1 g every 6 hours VO
If additional merit the first choice analgesic diclofenac 75mg IM is, if no answer will apply a dose of 100mg tramadol or morphine IV in titrated only if warranted more analgesia.
For all patients will have availability of naloxone in case of respiratory depression.
Patients will be observed for 24 hours with monitoring the consumption of other analgesics, pain visual analog scale, which is evaluated at the time of the application of morphine, 2h, 4h, 6h 12h and 24h after application of morphine. Also evaluated variables such as development of pruritus, nausea, vomiting, urinary retention and assessment of respiratory rate.
- Conditions
- Labor Pain
- Being tested
- Morphine, saline solution
- Keywords
- Epidural opioid, Morphine, Postpartum pain, Analgesia, Perineorraphy
- Medical subject headings
- Labor Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MorphineDrug
Also called Random code numbers
morphine 3 mg
saline solutionDrug
Also called Random code numbers
4 cc of saline solution in epidural cateter in postpartum
MorphineDrug
Also called Random code numbers
morphine 2 mg for epidural cateter in postpartum
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Patients en treatment whit placebo, salIne solution in peridural cateter Receives: Drug: saline solution |
| Morphine | Active comparator | Epidural Catheter morphine 2mg Receives: Drug: Morphine |
| morphine | Active comparator | Epidurla cateter morphine 3 mg Receives: Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The analgesic efficacy: : pain intensity rating
The analgesic efficacy at controlling pain after delivery
Measured: The first 24 hours after administration
Secondary outcomes (1)
the incidence of side effects
In particular those described in the literature, such as pruritus, nausea, vomiting, urinary retention and respiratory depression
Measured: the first 24 hours after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study startMar 2009
- Primary completionApr 2010
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Labor PainStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional de Colombia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dario J Perea, Medical, Study chair, Universidad Nacional de Colombia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04887649
- Sponsor's protocol ID
- 7245408
- Acronym
- IMI
- Status last verified
- May 2021
- First submitted
- 13 Oct 2011
- Last updated
- 14 May 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Wang JK, Nauss LA, Thomas JE. Pain relief by intrathecally applied morphine in man. Anesthesiology. 1979 Feb;50(2):149-51. doi: 10.1097/00000542-197902000-00013. No abstract available.
PubMed 373503Macarthur AJ, Macarthur C. Incidence, severity, and determinants of perineal pain after vaginal delivery: a prospective cohort study. Am J Obstet Gynecol. 2004 Oct;191(4):1199-204. doi: 10.1016/j.ajog.2004.02.064.
PubMed 15507941Macarthur A, Imarengiaye C, Tureanu L, Downey K. A randomized, double-blind, placebo-controlled trial of epidural morphine analgesia after vaginal delivery. Anesth Analg. 2010 Jan 1;110(1):159-64. doi: 10.1213/ANE.0b013e3181c30f78. Epub 2009 Nov 12.
PubMed 19910627Goodman SR, Drachenberg AM, Johnson SA, Negron MA, Kim-Lo SH, Smiley RM. Decreased postpartum use of oral pain medication after a single dose of epidural morphine. Reg Anesth Pain Med. 2005 Mar-Apr;30(2):134-9. doi: 10.1016/j.rapm.2004.11.010.
PubMed 15765455Behar M, Magora F, Olshwang D, Davidson JT. Epidural morphine in treatment of pain. Lancet. 1979 Mar 10;1(8115):527-9. doi: 10.1016/s0140-6736(79)90947-4.
PubMed 85109Davies GK, Tolhurst-Cleaver CL, James TL. Respiratory depression after intrathecal narcotics. Anaesthesia. 1980 Nov;35(11):1080-3. doi: 10.1111/j.1365-2044.1980.tb05047.x.
PubMed 6893789Soni AK, Miller CG, Pratt SD, Hess PE, Oriol NE, Sarna MC. Low dose intrathecal ropivacaine with or without sufentanil provides effective analgesia and does not impair motor strength during labour: a pilot study. Can J Anaesth. 2001 Jul-Aug;48(7):677-80. doi: 10.1007/BF03016202.
PubMed 11495875Carvalho B. Respiratory depression after neuraxial opioids in the obstetric setting. Anesth Analg. 2008 Sep;107(3):956-61. doi: 10.1213/ane.0b013e318168b443.
PubMed 18713913Fuller JG, McMorland GH, Douglas MJ, Palmer L. Epidural morphine for analgesia after caesarean section: a report of 4880 patients. Can J Anaesth. 1990 Sep;37(6):636-40. doi: 10.1007/BF03006481.
PubMed 2208533Darío José PS, Ricardo N, Pedro H, Viviana C, Andrea G, Andrés G et al . Randomized double-blind controlled clinical trial for the evaluation of post-partum analgesia using epidural morphine: analgesic effectiveness of different dose regimes compared with placebo. Rev. colomb. anestesiol. 2012 Apr [cited 2021 May 04] ; 40( 1 ): 8-13. Available from: http://www.scielo.org.co/scielo.php?script=sci_arttext&pid=S0120-33472012000100004&lng=en. https://doi.org/10.1016/S0120-3347(12)70004-7.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled, Double Blind, to Evaluate the Postpartum Analgesia With Epidural Morphine: Analgesic Effect of Two Different Doses Compared to Placebo
- ClinicalTrials.gov ID
- NCT04887649
- Acronym / sponsor ID
- IMI / 7245408
- Conditions
- Labor Pain
- Keywords
- Epidural opioid, Morphine, Postpartum pain, Analgesia, Perineorraphy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Universidad Nacional de ColombiaUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 14 May 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.
This study aims to assess the analgesic effect of two different doses of epidural morphine for postpartum analgesia management. Previous studies have shown that conventional management of postpartum pain (acetaminophen, NSAIDs) is insufficient, in the investigators country is wasted using the epidural catheter is placed as part of the analgesic management of pregnant women in labor.
Detailed description
The intervention is the epidural administration of morphine in two doses 2mg and 3mg different vs placebo 1 hour after delivery care maternal vaginal in patients who received epidural analgesia in labor, in order to evaluate the analgesic effectiveness post operations of the different doses vs placebo.
In the analysis to determine whether the proposed levels are effective for postpartum pain control was carried out by determining the differences between experimental groups and control group, and in examining the statistical significance of the differences found by applying the relevant tests according to whether the variable is normally distributed or not.
The main variables analyzed were:
rating of pain intensity, number of analgesics required required dose of analgesics used to achieve adequate control pain, number of pain episodes and percentage of patients free of these episodes, duration of action of the dose used.
Similar analysis was determined by the incidence of side effects, in particular those described in classic form, pruritus, nausea and vomiting, urinary retention, and respiratory depression
Were classified into three groups: two experimental and one control group.
Experimental Group 1 will receive 10 ml of solution prepared as follows:
2 mg of morphine diluted in 0.9% normal saline
Experimental Group 2 will receive 10 ml of solution prepared as follows:
3 mg of morphine diluted in 0.9% normal saline
The control group will receive 10 ml of normal saline (SSN).
The randomization codes were kept in a sealed envelope so individual, and the envelopes were guarded and uncovered after a eligible to participate in the study agreed to be included and signed the informed consent.
Anesthesia Technique for the Study
In ASA II patients in labor who were initiates of labor analgesia with epidural catheter has been placed ideally at the level of L3-L4 (Tuohy catheter conventional number 18, introduced by loss of resistance technique) .
The patients were started a conventional dose of analgesia with bupivacaine 0.5% + fentanyl 100mcg 10mg 10cc carried in a bolus. Administered bupivacaine + 10 mg bolus of fentanyl 100mcg as needed to strengthen the epidural analgesia
or Infusion Bupivacaine 0.125% + Fentanyl 100mcg%
In a 10cc bolus then 8-16CC hours
In patients 1 hour after having her expulsive morphine were previously applied in laboratory and packaged in disregard of the anesthesiologist applied morphine 2mg - 3mg or saline placebo.
The dose will be applied 1 hour after birth in search of having no residual analgesic effect of local anesthetic and opioid epidural analgesia initially applied.
All patients will be managed with conventional analgesia performed in the institution acetaminophen 1 g every 6 hours VO
If additional merit the first choice analgesic diclofenac 75mg IM is, if no answer will apply a dose of 100mg tramadol or morphine IV in titrated only if warranted more analgesia.
For all patients will have availability of naloxone in case of respiratory depression.
Patients will be observed for 24 hours with monitoring the consumption of other analgesics, pain visual analog scale, which is evaluated at the time of the application of morphine, 2h, 4h, 6h 12h and 24h after application of morphine. Also evaluated variables such as development of pruritus, nausea, vomiting, urinary retention and assessment of respiratory rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: saline solutionPatients en treatment whit placebo, salIne solution in peridural cateter |
| Morphine | Active comparator | Drug: MorphineEpidural Catheter morphine 2mg |
| morphine | Active comparator | Drug: MorphineEpidurla cateter morphine 3 mg |
Who may qualify
- Ages
- 14 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients postpartum vaginal conventional analgesia management of your labor
- ASA II
- Do not include patients with history of allergy to morphine.
- Patients who agreed to be included in the study but did not sign informed consent.
Key exclusion criteria (3 listed)
- Submit a complication that makes it difficult postoperative pain assessment or adverse effects after surgery.
- Patients who, after having been included, express their desire to be excluded. Patients with incomplete follow-up.id
- Did not include patients who have absolute contraindications for epidural anesthesia, or could not provide informed consent, as in the following cases: local infection at the site of administration, systemic infection, bleeding disorders, disease of the spine , mental patients, drug history, sleep apnea, history of headache post-puncture headache or frequent any kind.
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: Random code numbersmorphine 3 mg | Drug | Morphine, morphine |
| saline solutionAlso: Random code numbers4 cc of saline solution in epidural cateter in postpartum | Drug | Placebo |
| MorphineAlso: Random code numbersmorphine 2 mg for epidural cateter in postpartum | Drug | Morphine, morphine |
Primary outcome
The analgesic efficacy: : pain intensity rating
Time frame: The first 24 hours after administration
The analgesic efficacy at controlling pain after delivery
1 secondary outcome
the incidence of side effects
Time frame: the first 24 hours after administration
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 14 May 2021.
- Background: PubMed 373503Wang JK, Nauss LA, Thomas JE. Pain relief by intrathecally applied morphine in man. Anesthesiology. 1979 Feb;50(2):149-51. doi: 10.1097/00000542-197902000-00013. No abstract available.
- Background: PubMed 15507941Macarthur AJ, Macarthur C. Incidence, severity, and determinants of perineal pain after vaginal delivery: a prospective cohort study. Am J Obstet Gynecol. 2004 Oct;191(4):1199-204. doi: 10.1016/j.ajog.2004.02.064.
- Background: PubMed 19910627Macarthur A, Imarengiaye C, Tureanu L, Downey K. A randomized, double-blind, placebo-controlled trial of epidural morphine analgesia after vaginal delivery. Anesth Analg. 2010 Jan 1;110(1):159-64. doi: 10.1213/ANE.0b013e3181c30f78. Epub 2009 Nov 12.
- Background: PubMed 15765455Goodman SR, Drachenberg AM, Johnson SA, Negron MA, Kim-Lo SH, Smiley RM. Decreased postpartum use of oral pain medication after a single dose of epidural morphine. Reg Anesth Pain Med. 2005 Mar-Apr;30(2):134-9. doi: 10.1016/j.rapm.2004.11.010.
- Background: PubMed 85109Behar M, Magora F, Olshwang D, Davidson JT. Epidural morphine in treatment of pain. Lancet. 1979 Mar 10;1(8115):527-9. doi: 10.1016/s0140-6736(79)90947-4.
- Background: PubMed 6893789Davies GK, Tolhurst-Cleaver CL, James TL. Respiratory depression after intrathecal narcotics. Anaesthesia. 1980 Nov;35(11):1080-3. doi: 10.1111/j.1365-2044.1980.tb05047.x.
- Background: PubMed 11495875Soni AK, Miller CG, Pratt SD, Hess PE, Oriol NE, Sarna MC. Low dose intrathecal ropivacaine with or without sufentanil provides effective analgesia and does not impair motor strength during labour: a pilot study. Can J Anaesth. 2001 Jul-Aug;48(7):677-80. doi: 10.1007/BF03016202.
- Background: PubMed 18713913Carvalho B. Respiratory depression after neuraxial opioids in the obstetric setting. Anesth Analg. 2008 Sep;107(3):956-61. doi: 10.1213/ane.0b013e318168b443.
- Background: PubMed 2208533Fuller JG, McMorland GH, Douglas MJ, Palmer L. Epidural morphine for analgesia after caesarean section: a report of 4880 patients. Can J Anaesth. 1990 Sep;37(6):636-40. doi: 10.1007/BF03006481.
- Results publicationDarío José PS, Ricardo N, Pedro H, Viviana C, Andrea G, Andrés G et al . Randomized double-blind controlled clinical trial for the evaluation of post-partum analgesia using epidural morphine: analgesic effectiveness of different dose regimes compared with placebo. Rev. colomb. anestesiol. 2012 Apr [cited 2021 May 04] ; 40( 1 ): 8-13. Available from: http://www.scielo.org.co/scielo.php?script=sci_arttext&pid=S0120-33472012000100004&lng=en. https://doi.org/10.1016/S0120-3347(12)70004-7.
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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.
Dario J Perea, Medical study chair
Universidad Nacional de Colombia
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 Morphine and saline solution in people with Labor Pain, run by Universidad Nacional de Colombia at 1 site in Colombia.
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 4 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 14 May 2021. 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 Colombia. 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 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 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?
The analgesic efficacy: : pain intensity rating (time frame: The first 24 hours after administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04887649, which also lists 10 linked publications.
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 14 May 2021.