Labour AnalgesiaNCT02800694
Role of the Single-shot Spinal Analgesia to Control Labour Pain
A study testing "bupivacainediluted with 1 ml of normal saline" and "25 μg fentanyl " in people with Labour Analgesia, run by Minia University at 1 site in Egypt.
Trial summary
Labor pain is the most severe pain most women will endure in their lifetimes. The most complete and effective method of pain relief during childbirth is neuraxial labor analgesia which provides adequate analgesia without maternal or fetal sedation. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labour Analgesia
- What is being tested?
- "bupivacainediluted with 1 ml of normal saline" and "25 μg fentanyl "
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Jul 2016to Nov 2016
- 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 18 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- primigravida parturients with ASA physical status I and II, term pregnancy of singleton fetus, all vertex presentation and uncomplicated pregnancies.
- After the parturients being in active labor, dilated at least 4 to 5 cm and asking for painless labor, they were selected by an experienced obstetrician to receive spinal analgesia, based on obstetric parameters such as cervical dilatation and effacement and position of the fetal head
Who cannot join
- patients with contraindications to regional anesthesia, diagnosed fetal abnormalities, allergy to the study drugs or previous systemic opioid administration
Trial locations and contacts
1 site in 1 country.
Wegdan A Abdelrahman, MD contact
Egypt1 site
Department of Obstetrics and Gynaecology, Minia University Hospital
Minya
About this study
Official title: Role of the Single-shot Spinal Analgesia to Control Labour Pain in Appropriately-selected Primiparous Parturients: A Prospective Study
Labor pain is the most severe pain most women will endure in their lifetimes. The most complete and effective method of pain relief during childbirth is neuraxial labor analgesia which provides adequate analgesia without maternal or fetal sedation. Epidural and combined spinal-epidural (CSE) analgesia are the standard techniques performed in the developed countries. Having an epidural catheter in place produces flexibility with labor management. The catheter can be dosed intermittently for parturients in whom labor is prolonged, who require surgical manipulation for vaginal delivery, or who require cesarean section for delivery (1). However, unavailability of full-time epidural services in low-resource countries results in minimal or no analgesia provided to laboring parturients. The suitability of single-shot spinal analgesia has been previously studied in advanced, rapidly progressing labor in primiparous and multiparous women and was found that it may be a useful alternative for painless labor in the case of limited resources for epidural analgesia (2,3,4). However, duration of action is a limiting factor of intrathecal analgesia, particularly for primiparous women.
A 25 μg dose of fentanyl lasts 60-90 minutes. The study investigating the dose response relation for intrathecal fentanyl showed that the maximal analgesic effect is achieved at about 25 μg fentanyl. Above this dose, the duration of action increases but with increasing the incidence of side effects (5). Synergy has been noted between 25 μg of fentanyl and 2.5 mg of bupivacaine with analgesia lasting about 3 hours (6). The investigators hypothesized that increasing the bupivacaine dose to 5 mg with 25 μg fentanyl can prolong the duration of analgesia. So, this dosage combination can be used at an early stage in appropriately-selected primigravida parturients. The purpose of this study is to investigate the safety and effectiveness of single-dose spinal analgesia to control labor pain in properly-selected primiparous women in a tertiary referral maternity hospital
Read the detailed description
This prospective study will be conducted in El-Minia Maternity University Hospital after obtaining approval from the hospital ethical committee and informed consent from the participating parturients. The study will be conducted in the period from July to october 2016. Candidates for spinal analgesia included primigravida parturients with ASA physical status I and II, term pregnancy of singleton fetus, all vertex presentation and uncomplicated pregnancies. Excluded from the study were patients with contraindications to regional anesthesia, diagnosed fetal abnormalities, allergy to the study drugs or previous systemic opioid administration. After the parturients being in active labor, dilated at least 4 to 5 cm and asking for painless labor, they were selected by an experienced obstetrician to receive spinal analgesia, based on obstetric parameters such as cervical dilatation and effacement and position of the fetal head.
Following monitoring with noninvasive blood pressure, electrocardiogram and pulse oximeter and recording of baseline vital signs, 18-G intravenous cannula was inserted and Ringer's solution 10 ml/kg was administered. Under strict aseptic technique, spinal analgesia was performed using pencil-point 25G spinal needle at the L3-L4 or L4-L5 interspace with the patients in the sitting position. The intrathecal medication included 1ml of 0.5% heavy bupivacaine (5 mg) diluted with 1 ml of normal saline and 25 μg fentanyl. Then, the parturients were placed in the supine position with left lateral displacement produced by placing a wedge under the right hip to prevent aortocaval compression and hypotension. Supplemental oxygen was applied using nasal cannula (2-4 L/min). Routine monitoring included maternal vital signs, uterine contractions and fetal heart rate tracing. The cardiotocogram was recorded continuously throughout the study period
- Conditions
- Labour Analgesia
- Being tested
- "bupivacainediluted with 1 ml of normal saline" and "25 μg fentanyl "
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"bupivacainediluted with 1 ml of normal saline" and "25 μg fentanyl "Drug
The intrathecal medication included 1ml of 0.5% heavy bupivacaine (5 mg) diluted with 1 ml of normal saline and 25 μg fentanyl. Then, the parturients were placed in the supine position with left lateral displacement produced by placing a wedge under the right hip to prevent aortocaval compression and hypotension. Supplemental oxygen was applied using nasal cannula (2-4 L/min). Routine monitoring included maternal vital signs, uterine contractions and fetal heart rate tracing. The cardiotocogram was recorded continuously throughout the study period
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS) for assessment of degree of labour pain after administration of spinal analgesia
Measured: 6 hours after administration of spinal analgesia
Number of participants with treatment-related adverse events
Measured: Up to 24 hours after administration of spinal analgesia
Duration of pain relief
Measured: 12 hours after spinal analgesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionOct 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labour AnalgesiaStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Collaborators
- Dr Wegdan Ali Abdelrahman, Dr Haidy Salah
- Responsible party
- Principal investigator, Ahmed Rabie Abdelraheim, Minia University
- Investigators
- Ahmed R Abdelraheim, MD, MRCOG, Principal investigator, Department of Obstetrics and Gynaecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02800694
- Sponsor's protocol ID
- MUH2496
- Status last verified
- Jun 2016
- First submitted
- 31 May 2016
- Last updated
- 15 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of the Single-shot Spinal Analgesia to Control Labour Pain in Appropriately-selected Primiparous Parturients: A Prospective Study
- ClinicalTrials.gov ID
- NCT02800694
- Acronym / sponsor ID
- MUH2496
- Conditions
- Labour Analgesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Collaborators
- Dr Wegdan Ali Abdelrahman, Dr Haidy Salah
- Study start
- Jul 2016
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 15 Jun 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.
Labor pain is the most severe pain most women will endure in their lifetimes. The most complete and effective method of pain relief during childbirth is neuraxial labor analgesia which provides adequate analgesia without maternal or fetal sedation. Epidural and combined spinal-epidural (CSE) analgesia are the standard techniques performed in the developed countries. Having an epidural catheter in place produces flexibility with labor management. The catheter can be dosed intermittently for parturients in whom labor is prolonged, who require surgical manipulation for vaginal delivery, or who require cesarean section for delivery (1). However, unavailability of full-time epidural services in low-resource countries results in minimal or no analgesia provided to laboring parturients. The suitability of single-shot spinal analgesia has been previously studied in advanced, rapidly progressing labor in primiparous and multiparous women and was found that it may be a useful alternative for painless labor in the case of limited resources for epidural analgesia (2,3,4). However, duration of action is a limiting factor of intrathecal analgesia, particularly for primiparous women.
A 25 μg dose of fentanyl lasts 60-90 minutes. The study investigating the dose response relation for intrathecal fentanyl showed that the maximal analgesic effect is achieved at about 25 μg fentanyl. Above this dose, the duration of action increases but with increasing the incidence of side effects (5). Synergy has been noted between 25 μg of fentanyl and 2.5 mg of bupivacaine with analgesia lasting about 3 hours (6). The investigators hypothesized that increasing the bupivacaine dose to 5 mg with 25 μg fentanyl can prolong the duration of analgesia. So, this dosage combination can be used at an early stage in appropriately-selected primigravida parturients. The purpose of this study is to investigate the safety and effectiveness of single-dose spinal analgesia to control labor pain in properly-selected primiparous women in a tertiary referral maternity hospital
Detailed description
This prospective study will be conducted in El-Minia Maternity University Hospital after obtaining approval from the hospital ethical committee and informed consent from the participating parturients. The study will be conducted in the period from July to october 2016. Candidates for spinal analgesia included primigravida parturients with ASA physical status I and II, term pregnancy of singleton fetus, all vertex presentation and uncomplicated pregnancies. Excluded from the study were patients with contraindications to regional anesthesia, diagnosed fetal abnormalities, allergy to the study drugs or previous systemic opioid administration. After the parturients being in active labor, dilated at least 4 to 5 cm and asking for painless labor, they were selected by an experienced obstetrician to receive spinal analgesia, based on obstetric parameters such as cervical dilatation and effacement and position of the fetal head.
Following monitoring with noninvasive blood pressure, electrocardiogram and pulse oximeter and recording of baseline vital signs, 18-G intravenous cannula was inserted and Ringer's solution 10 ml/kg was administered. Under strict aseptic technique, spinal analgesia was performed using pencil-point 25G spinal needle at the L3-L4 or L4-L5 interspace with the patients in the sitting position. The intrathecal medication included 1ml of 0.5% heavy bupivacaine (5 mg) diluted with 1 ml of normal saline and 25 μg fentanyl. Then, the parturients were placed in the supine position with left lateral displacement produced by placing a wedge under the right hip to prevent aortocaval compression and hypotension. Supplemental oxygen was applied using nasal cannula (2-4 L/min). Routine monitoring included maternal vital signs, uterine contractions and fetal heart rate tracing. The cardiotocogram was recorded continuously throughout the study period
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- primigravida parturients with ASA physical status I and II, term pregnancy of singleton fetus, all vertex presentation and uncomplicated pregnancies.
- After the parturients being in active labor, dilated at least 4 to 5 cm and asking for painless labor, they were selected by an experienced obstetrician to receive spinal analgesia, based on obstetric parameters such as cervical dilatation and effacement and position of the fetal head
Key exclusion criteria (1 listed)
- patients with contraindications to regional anesthesia, diagnosed fetal abnormalities, allergy to the study drugs or previous systemic opioid administration
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 |
|---|---|---|
| "bupivacainediluted with 1 ml of normal saline" and "25 μg fentanyl "The intrathecal medication included 1ml of 0.5% heavy bupivacaine (5 mg) diluted with 1 ml of normal saline and 25 μg fentanyl. Then, the parturients were placed in the supine position with left lateral displacement produced by placing a wedge under the right hip to prevent aortocaval compression and hypotension. Supplemental oxygen was applied using nasal cannula (2-4 L/min). Routine monitoring included maternal vital signs, uterine contractions and fetal heart rate tracing. The cardiotocogram was recorded continuously throughout the study period | Drug | – |
Primary outcome
Visual Analogue Scale (VAS) for assessment of degree of labour pain after administration of spinal analgesia
Time frame: 6 hours after administration of spinal analgesia
Number of participants with treatment-related adverse events
Time frame: Up to 24 hours after administration of spinal analgesia
Duration of pain relief
Time frame: 12 hours after spinal analgesia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2016.
- Individual participant dataSharing planned: No
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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.
Wegdan A Abdelrahman, MD contact
Ahmed R Abdelraheim, MD, MRCOG principal investigator
Department of Obstetrics and Gynaecology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "bupivacainediluted with 1 ml of normal saline" and "25 μg fentanyl " in people with Labour Analgesia, run by Minia University at 1 site in Egypt.
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 1 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: status not confirmed, as of the sponsor's last update on 15 Jun 2016. 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 Egypt. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wegdan A Abdelrahman, MD (00201002522558), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS) for assessment of degree of labour pain after administration of spinal analgesia (time frame: 6 hours after administration of spinal analgesia). The study lists 3 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 15 Jun 2016.