Labor PainNCT02498171
Labour Analgesia; Comparing a Combinations of Either Fentanyl or Bupivacaine With Intrathecal Morphine
A study testing Intrathecal morphine with fentanyl and Intrathecal morphine with bupivacaine in people with Labor Pain, run by Makerere University.
Trial summary
This study is aimed at evaluating single short spinal technique as a form of labour analgesia in a setting where more expensive and labor intensive techniques are not feasible.The study will examine the safety and efficacy of two drug combinations (intrathecal morphine+fentanyl vs intrathecal morphine+bupivacaine)… Read more about this study
- Who is it for?
- Ages 14 to 60 years, women only
- Conditions the study is for
- Labor Pain
- What is being tested?
- Intrathecal morphine with fentanyl and Intrathecal morphine with bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Mar 2014
- Phase
- Interventional
- 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 60 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Parturients with singleton pregnancy
- Emancipated minors
Who cannot join
- Those who declined.
- Parturients with any identified complication of labour like preeclampsia, severe cardiac disease or previous operative delivery.
- Sepsis or wound at site of spinal injection.
- Allergy to any of the study drugs elicited from history.
About this study
Official title: Evaluation Of Efficacy And Safety Of Labour Analgesia By Intrathecal Morphine With Fentanyl Compared To Morphine With Bupivacaine In Mulago Hospital: A Double-blinded Randomized Control Trial
This study is aimed at evaluating single short spinal technique as a form of labour analgesia in a setting where more expensive and labor intensive techniques are not feasible.The study will examine the safety and efficacy of two drug combinations (intrathecal morphine+fentanyl vs intrathecal morphine+bupivacaine) through a randomized control trial.
The investigators hypothesize that a single shot of either intrathecal morphine plus fentanyl or intrathecal morphine plus bupivacaine achieve analgesia and are safe in parturients experiencing normal labour.
- Conditions
- Labor Pain
- Being tested
- Intrathecal morphine with fentanyl, Intrathecal morphine with bupivacaine
- Keywords
- Labour analgesia, Intrathecal morphine, Bupivacaine, Fentanyl
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathecal morphine with fentanylDrug
Also called Morphine Sulphate 10mg/ml, Ampoule 1ml,Martindale Hong Kong, Fentanyl Citrate 0.05mg/ml, Ampoule 2ml,Martindale Hong Kong
Parturients in this arm underwent a single shot spinal following standard procedure. the drug mixture was then introduced into the subarachnoid space following free flow of csf. the parturient was the monitored fo labour progression using the standard partogram, vital signs and the visual analogue scale score for pain recorded every 5 min.
The fetus was monitored with an ultrasonic aided fetal Doppler until delivery
Intrathecal morphine with bupivacaineDrug
Also called Morphine Sulphate 10mg/ml, Ampoule 1ml, Martindale Hong Kong, sesorcaine 0.5%, Ampoule 4ml, Astrazeneca
Parturients in this arm underwent a single shot spinal following standard procedure. the drug mixture was then introduced into the subarachnoid space following free flow of csf. the parturient was the monitored fo labour progression using the standard partogram, vital signs and the visual analogue scale score for pain recorded every 5 min.
The fetus was monitored with an ultrasonic aided fetal Doppler until delivery
| Study group | Role | What they receive |
|---|---|---|
| Intrathecal morphine with fentanyl | Experimental | Single shot of intrathecal morphine 100mcg mixed with 25mcg of fentanyl and filled up to make a 2ml solution. This would then be injected into the subarachnoid space through L2-3 or L3-4 following standard procedures. Receives: Drug: Intrathecal morphine with fentanyl |
| Intrathecal morphine with bupivacaine | Active comparator | Single shot of intrathecal morphine 100mcg mixed with 2.5mg of spinal bupivacaine and filled up to make a 2ml solution.This would then be injected into the subarachnoid space through L2-3 or L3-4 following standard procedures. Receives: Drug: Intrathecal morphine with bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of analgesia
Monitoring the level of pain by the visual analogue scale to determine the total duration of analgesia in hours starting 5 min after drug administration
Measured: 10 hours
Secondary outcomes (2)
APGAR score
The effect of the drugs to the fetus shall be determined by proxy from the APGAR scores of the baby determined at 1 minute and then at 5 minutes. Poor APGAR scores are those equal or less than seven (7).
Measured: 6 minutes
Maternal side effects (composite)
Maternal side effects including pruritis, urinary retention, high Bromage score, nausea and vomiting, abnormal blood pressure and pulse rate will be ascertained 24 hours after delivery.
Measured: 34 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2015 (estimated)
- Study startJan 2014
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Makerere University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Kintu, M.med, Study director, Department of Anesthesia and Critical Care, Makerere University, College of Health Sciences, Kampala,UgandaTimothy Muyimbo, M.med, Principal investigator, Department of Anesthesia and Critical Care, Makerere University, College of Health Sciences, Kampala,UgandaFred Bulamba, M.med, Study chair, Department of Anesthesia and Critical Care, Makerere University, College of Health Sciences, Kampala,Uganda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02498171
- Sponsor's protocol ID
- 2011/HD07/2061U
- Status last verified
- Jul 2015
- First submitted
- 7 Jul 2015
- Last updated
- 15 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Decosterd I, Beggah AT, Durrer A, Buchser E. [Spinal opioids: mechanisms of action and chronic pain management]. Rev Med Suisse. 2006 Jun 21;2(71):1636-8, 1640. French.
PubMed 16878530Cascio M, Pygon B, Bernett C, Ramanathan S. Labour analgesia with intrathecal fentanyl decreases maternal stress. Can J Anaesth. 1997 Jun;44(6):605-9. doi: 10.1007/BF03015443.
PubMed 9187779Fontaine P, Adam P, Svendsen KH. Should intrathecal narcotics be used as a sole labor analgesic? A prospective comparison of spinal opioids and epidural bupivacaine. J Fam Pract. 2002 Jul;51(7):630-5.
PubMed 12160502
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of Efficacy And Safety Of Labour Analgesia By Intrathecal Morphine With Fentanyl Compared To Morphine With Bupivacaine In Mulago Hospital: A Double-blinded Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02498171
- Acronym / sponsor ID
- 2011/HD07/2061U
- Conditions
- Labor Pain
- Keywords
- Labour analgesia, Intrathecal morphine, Bupivacaine, Fentanyl
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Makerere UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 15 Jul 2015 (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.
This study is aimed at evaluating single short spinal technique as a form of labour analgesia in a setting where more expensive and labor intensive techniques are not feasible.The study will examine the safety and efficacy of two drug combinations (intrathecal morphine+fentanyl vs intrathecal morphine+bupivacaine) through a randomized control trial.
The investigators hypothesize that a single shot of either intrathecal morphine plus fentanyl or intrathecal morphine plus bupivacaine achieve analgesia and are safe in parturients experiencing normal labour.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intrathecal morphine with fentanyl | Experimental | Drug: Intrathecal morphine with fentanylSingle shot of intrathecal morphine 100mcg mixed with 25mcg of fentanyl and filled up to make a 2ml solution. This would then be injected into the subarachnoid space through L2-3 or L3-4 following standard procedures. |
| Intrathecal morphine with bupivacaine | Active comparator | Drug: Intrathecal morphine with bupivacaineSingle shot of intrathecal morphine 100mcg mixed with 2.5mg of spinal bupivacaine and filled up to make a 2ml solution.This would then be injected into the subarachnoid space through L2-3 or L3-4 following standard procedures. |
Who may qualify
- Ages
- 14 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Parturients with singleton pregnancy
- Emancipated minors
Key exclusion criteria (4 listed)
- Those who declined.
- Parturients with any identified complication of labour like preeclampsia, severe cardiac disease or previous operative delivery.
- Sepsis or wound at site of spinal injection.
- Allergy to any of the study drugs elicited from history.
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 |
|---|---|---|
| Intrathecal morphine with fentanylAlso: Morphine Sulphate 10mg/ml, Ampoule 1ml,Martindale Hong Kong, Fentanyl Citrate 0.05mg/ml, Ampoule 2ml,Martindale Hong KongParturients in this arm underwent a single shot spinal following standard procedure. the drug mixture was then introduced into the subarachnoid space following free flow of csf. the parturient was the monitored fo labour progression using the standard partogram, vital signs and the visual analogue scale score for pain recorded every 5 min. The fetus was monitored with an ultrasonic aided fetal Doppler until delivery | Drug | Intrathecal morphine with fentanyl |
| Intrathecal morphine with bupivacaineAlso: Morphine Sulphate 10mg/ml, Ampoule 1ml, Martindale Hong Kong, sesorcaine 0.5%, Ampoule 4ml, AstrazenecaParturients in this arm underwent a single shot spinal following standard procedure. the drug mixture was then introduced into the subarachnoid space following free flow of csf. the parturient was the monitored fo labour progression using the standard partogram, vital signs and the visual analogue scale score for pain recorded every 5 min. The fetus was monitored with an ultrasonic aided fetal Doppler until delivery | Drug | Intrathecal morphine with bupivacaine |
Primary outcome
Duration of analgesia
Time frame: 10 hours
Monitoring the level of pain by the visual analogue scale to determine the total duration of analgesia in hours starting 5 min after drug administration
2 secondary outcomes
APGAR score
Time frame: 6 minutes
Maternal side effects (composite)
Time frame: 34 hours
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 15 Jul 2015.
- Results publication: PubMed 16878530Decosterd I, Beggah AT, Durrer A, Buchser E. [Spinal opioids: mechanisms of action and chronic pain management]. Rev Med Suisse. 2006 Jun 21;2(71):1636-8, 1640. French.
- Results publication: PubMed 9187779Cascio M, Pygon B, Bernett C, Ramanathan S. Labour analgesia with intrathecal fentanyl decreases maternal stress. Can J Anaesth. 1997 Jun;44(6):605-9. doi: 10.1007/BF03015443.
- Results publication: PubMed 12160502Fontaine P, Adam P, Svendsen KH. Should intrathecal narcotics be used as a sole labor analgesic? A prospective comparison of spinal opioids and epidural bupivacaine. J Fam Pract. 2002 Jul;51(7):630-5.
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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.
Andrew Kintu, M.med study director
Department of Anesthesia and Critical Care, Makerere University, College of Health Sciences, Kampala,Uganda
Timothy Muyimbo, M.med principal investigator
Department of Anesthesia and Critical Care, Makerere University, College of Health Sciences, Kampala,Uganda
Fred Bulamba, M.med study chair
Department of Anesthesia and Critical Care, Makerere University, College of Health Sciences, Kampala,Uganda
Questions about this trial
What is this clinical trial studying?
A study testing Intrathecal morphine with fentanyl and Intrathecal morphine with bupivacaine in people with Labor Pain, run by Makerere University.
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 2 inclusion and 4 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 15 Jul 2015. 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.
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?
Duration of analgesia (time frame: 10 hours). 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 NCT02498171, which also lists 3 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 15 Jul 2015.