Labor PainPhase 2/3NCT05781854
Dexmedetomidine for Intermittent Epidural Boluses Versus Continuous Epidural Infusion for Labour Epidural Analgesia
A Phase 2/3 study testing Epidural analgesia with bupivacaine and dexmedetomidine in people with Labor Pain, run by Assiut University at 1 site in Egypt.
Trial summary
The aim of this study is to compare two modes of labour epidural analgesia: programmed intermittent epidural boluses (PIEB) versus continuous epidural infusion (CEI), with patient controlled epidural analgesia (PCEA), using dexmedetomidine in addition to low-dose bupivacaine and through measuring the total volume of… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain
- What is being tested?
- Epidural analgesia with bupivacaine and dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 29 May 2023to 1 Oct 2025
- Phase
- Phase 2/3
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18 - 45 years
- Scheduled for normal vaginal delivery
- ASA physical status ӀI-IӀӀ.
- Singleton non-complicated pregnancy.
- At least 36 weak of gestation.
- Vertex presentation.
Who cannot join
- Patient refusal to epidural analgesia.
- History of cardiac, liver, or kidney diseases.
- History of allergy to amide local anesthetics or study medications.
- Any neurological problem.
- History of chronic opioid analgesic use.
- Any contraindication of regional anesthesia.
Show all 9Show fewer
- Evidence of intrauterine growth restriction or fetal compromise.
- Failed or unsatisfactory analgesic block.
- Body mass index ≥40 kg/m2
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut university hospital
Asyut, 71111
Mohamed Fathy Mostafa, Assistant professor, 01001123062 ext. +20, mo7_fathy@aun.edu.eg
About this study
Official title: Dexmedetomidine for Programed Intermittent Epidural Boluses Versus Continuous Epidural Infusion for Labour Epidural Analgesia: A Randomized Controlled Double-blind Trial
The aim of this study is to compare two modes of labour epidural analgesia:
programmed intermittent epidural boluses (PIEB) versus continuous epidural infusion (CEI), with patient controlled epidural analgesia (PCEA), using dexmedetomidine in addition to low-dose bupivacaine and through measuring the total volume of local anesthetic received through patient controlled epidural analgesia per hour
Read the detailed description
Labour although varies with the individual may be the most painful experience, any women may ever encounter. Concerns about pain in labour are as old as mankind. Pain can make patients feel uncomfortable and become sleepless and agitated. Pain also stimulates the sympathetic nervous system, which causes increase in the heart rate, blood pressure, sweat production, endocrine hyper-function, and delays the patients' prognosis. Labor pain often causes a strong stress response. Several inhalation and parenteral anesthetics, sedatives, tranquilizers, and analgesics have been used for pain relief during labor, while over the last decade, lumbar epidural analgesia has greatly increased. The ideal labor analgesia should be based on maternal and child safety and should have a fast-acting good analgesic effect and less adverse reaction. Different adjuvants such as opioids and α2-adrenergic agonists were added to local anesthetics to improve the quality of intraoperative and postoperative analgesia. Dexmedetomidine is a highly selective 2-adrenergic agonist which has been used as pre-medication and as an adjuvant to general anesthesia . Dexmedetomidine have several beneficial actions during perioperative period. It decreases the sympathetic tone with attenuation of the neuroendocrine and hemodynamic response to anesthesia and surgery, reduce anesthetic and opioid requirement, cause sedation and analgesia. Dexmedetomidine was used to enhance the analgesic property of local anesthetics like lidocaine, bupivacaine and ropivacaine. The mechanism by which intrathecal alpha 2-adrenergic agonists prolong the motor and sensory block of local anesthetics is not clear. It may be an additive or synergistic effect secondary to the different mechanisms of action of local anesthetic and alpha 2-adrenergic agonist. Maintenance of epidural analgesia involved intermittent provider , administered boluses, patient-controlled epidural analgesia, and continuous epidural infusions with or without patient-controlled epidural analgesia. Continuous epidural infusion is the standard application setting for epidural infusion, highly effective, and provides consistent analgesia. however, is associated with greater local anesthetic consumption . A newer approach to maintenance of labor epidural analgesia involves the administration of programmed intermittent epidural boluses with patient-controlled epidural analgesia dosing for breakthrough pain. Earlier studies have suggested that programmed intermittent epidural boluses may be superior to continuous epidural infusion for labor analgesia and may be associated with a reduction in local anesthetic requirement, decreased motor blockade, lower risk of instrumental deliveries, and improved patient satisfaction. This may be related to increased pressure generated during automated boluses, resulting in improved distribution of the local anesthetic in the epidural space .
- Conditions
- Labor Pain
- Being tested
- Epidural analgesia with bupivacaine and dexmedetomidine
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural analgesia with bupivacaine and dexmedetomidineDrug
Epidural analgesia with bupivacaine and dexmedetomidine
| Study group | Role | What they receive |
|---|---|---|
| Group P (PIEB-group) | Active comparator | After the initial epidural loading dose of 10 ml, 30 patients will receive programmed intermittent epidural boluses (5 ml every 45 min with the first bolus 30 minutes after epidural initiation) + patient controlled epidural analgesia (PCEA) as 5 ml boluses with a 20-minute lockout period). Receives: Drug: Epidural analgesia with bupivacaine and dexmedetomidine |
| Group C (CEI-group) | Active comparator | After the initial epidural loading dose of 10 ml, 30 patients will receive continuous epidural infusion (5 ml/h starting immediately after the loading dose) + patient controlled epidural analgesia (PCEA) as 5 ml boluses with a 20-minute lockout period). Receives: Drug: Epidural analgesia with bupivacaine and dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
total volume of local anesthetic
total volume of local anesthetic received through patient controlled epidural analgesia per hour
Measured: 24 hour
Secondary outcomes (5)
Ramsay sedation scale
Completely awake or asleep and not responsive to any stimulus
Measured: 24 hour
Heart rate
Beat per minute
Measured: 24 hour
Blood Pressure
mmHg
Measured: 24 hour
Likert scale for satisfaction
very satisfied or very dissatisfied
Measured: 24 hour
Bromage score for motor block
free movement of legs and feet or unable to move legs and feet
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start29 May 2023
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Labor PainStudies of the same condition, open and under way.
- More trials run by Assiut 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hassan Khaled ahmed gomaa, Assiut University
- Investigators
- Zein El-Abden Zareh Hassan, Professor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05781854
- Sponsor's protocol ID
- Dexmedetomidine in normallabor
- Status last verified
- Apr 2024
- First submitted
- 23 Feb 2023
- Last updated
- 9 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ebirim, L.N., Buowari, O.Y., Ghosh, S. Physical and Psychological Aspects of Pain in Obstetrics. In: Ghosh, S., editor. Pain in Perspective [Internet]. London: IntechOpen; 2012 [cited 2022 Oct 18]. Available from: https://www.intechopen.com/chapters/40395 doi: 10.5772/53923
Fortescue C, Wee MYK. Analgesia in labour: non-regional techniques. Continuing Education in Anaesthesia, Critical Care, and Pain. 2005; 5(1): 219-223.
Paramasivan A, Lopez-Olivo MA, Foong TW, Tan YW, Yap APA. Intrathecal dexmedetomidine and postoperative pain: A systematic review and meta-analysis of randomized controlled trials. Eur J Pain. 2020 Aug;24(7):1215-1227. doi: 10.1002/ejp.1575. Epub 2020 May 22.
PubMed 32333825Verghese T, Dixit N, John L, et al. Effect of intravenous dexmedetomidine on duration of spinal anaesthesia with hyperbaric bupivacaine - A comparative study. Indian J Clin Anaesth. 2019;6(1):97-101
Mostafa MF, Herdan R, Fathy GM, Hassan ZEAZ, Galal H, Talaat A, Ibrahim AK. Intrathecal dexmedetomidine versus magnesium sulphate for postoperative analgesia and stress response after caesarean delivery; randomized controlled double-blind study. Eur J Pain. 2020 Jan;24(1):182-191. doi: 10.1002/ejp.1476. Epub 2019 Sep 12.
PubMed 31461801Martin E, Ramsay G, Mantz J, Sum-Ping ST. The role of the alpha2-adrenoceptor agonist dexmedetomidine in postsurgical sedation in the intensive care unit. J Intensive Care Med. 2003 Jan-Feb;18(1):29-41. doi: 10.1177/0885066602239122.
PubMed 15189665Gertler R, Brown HC, Mitchell DH, Silvius EN. Dexmedetomidine: a novel sedative-analgesic agent. Proc (Bayl Univ Med Cent). 2001 Jan;14(1):13-21. doi: 10.1080/08998280.2001.11927725.
PubMed 16369581Werdehausen R, Fazeli S, Braun S, Hermanns H, Essmann F, Hollmann MW, Bauer I, Stevens MF. Apoptosis induction by different local anaesthetics in a neuroblastoma cell line. Br J Anaesth. 2009 Nov;103(5):711-8. doi: 10.1093/bja/aep236. Epub 2009 Aug 22.
PubMed 19700777Fairbanks CA, Wilcox GL. Spinal antinociceptive synergism between morphine and clonidine persists in mice made acutely or chronically tolerant to morphine. J Pharmacol Exp Ther. 1999 Mar;288(3):1107-16.
PubMed 10027848Sng BL, Sia ATH. Maintenance of epidural labour analgesia: The old, the new and the future. Best Pract Res Clin Anaesthesiol. 2017 Mar;31(1):15-22. doi: 10.1016/j.bpa.2017.01.002. Epub 2017 Jan 12.
PubMed 28625301Ojo OA, Mehdiratta JE, Gamez BH, Hunting J, Habib AS. Comparison of Programmed Intermittent Epidural Boluses With Continuous Epidural Infusion for the Maintenance of Labor Analgesia: A Randomized, Controlled, Double-Blind Study. Anesth Analg. 2020 Feb;130(2):426-435. doi: 10.1213/ANE.0000000000004104.
PubMed 30882524Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
PubMed 17695343El Fawal, S., El Kabarity, R., Ahmed, N., Abd-El-Tawab, S. (2022). Effect of Epidural Dexmedetomidine vs Nalbuphine for Labor Analgesia. A randomized clinical trial. Egyptian J Anesthesia: 38 (1); 373382
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine for Programed Intermittent Epidural Boluses Versus Continuous Epidural Infusion for Labour Epidural Analgesia: A Randomized Controlled Double-blind Trial
- ClinicalTrials.gov ID
- NCT05781854
- Acronym / sponsor ID
- Dexmedetomidine in normallabor
- Conditions
- Labor Pain
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 29 May 2023 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 23 Mar 2023 (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.
The aim of this study is to compare two modes of labour epidural analgesia:
programmed intermittent epidural boluses (PIEB) versus continuous epidural infusion (CEI), with patient controlled epidural analgesia (PCEA), using dexmedetomidine in addition to low-dose bupivacaine and through measuring the total volume of local anesthetic received through patient controlled epidural analgesia per hour
Detailed description
Labour although varies with the individual may be the most painful experience, any women may ever encounter. Concerns about pain in labour are as old as mankind. Pain can make patients feel uncomfortable and become sleepless and agitated. Pain also stimulates the sympathetic nervous system, which causes increase in the heart rate, blood pressure, sweat production, endocrine hyper-function, and delays the patients' prognosis. Labor pain often causes a strong stress response. Several inhalation and parenteral anesthetics, sedatives, tranquilizers, and analgesics have been used for pain relief during labor, while over the last decade, lumbar epidural analgesia has greatly increased. The ideal labor analgesia should be based on maternal and child safety and should have a fast-acting good analgesic effect and less adverse reaction. Different adjuvants such as opioids and α2-adrenergic agonists were added to local anesthetics to improve the quality of intraoperative and postoperative analgesia. Dexmedetomidine is a highly selective 2-adrenergic agonist which has been used as pre-medication and as an adjuvant to general anesthesia . Dexmedetomidine have several beneficial actions during perioperative period. It decreases the sympathetic tone with attenuation of the neuroendocrine and hemodynamic response to anesthesia and surgery, reduce anesthetic and opioid requirement, cause sedation and analgesia. Dexmedetomidine was used to enhance the analgesic property of local anesthetics like lidocaine, bupivacaine and ropivacaine. The mechanism by which intrathecal alpha 2-adrenergic agonists prolong the motor and sensory block of local anesthetics is not clear. It may be an additive or synergistic effect secondary to the different mechanisms of action of local anesthetic and alpha 2-adrenergic agonist. Maintenance of epidural analgesia involved intermittent provider , administered boluses, patient-controlled epidural analgesia, and continuous epidural infusions with or without patient-controlled epidural analgesia. Continuous epidural infusion is the standard application setting for epidural infusion, highly effective, and provides consistent analgesia. however, is associated with greater local anesthetic consumption . A newer approach to maintenance of labor epidural analgesia involves the administration of programmed intermittent epidural boluses with patient-controlled epidural analgesia dosing for breakthrough pain. Earlier studies have suggested that programmed intermittent epidural boluses may be superior to continuous epidural infusion for labor analgesia and may be associated with a reduction in local anesthetic requirement, decreased motor blockade, lower risk of instrumental deliveries, and improved patient satisfaction. This may be related to increased pressure generated during automated boluses, resulting in improved distribution of the local anesthetic in the epidural space .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group P (PIEB-group) | Active comparator | Drug: Epidural analgesia with bupivacaine and dexmedetomidineAfter the initial epidural loading dose of 10 ml, 30 patients will receive programmed intermittent epidural boluses (5 ml every 45 min with the first bolus 30 minutes after epidural initiation) + patient controlled epidural analgesia (PCEA) as 5 ml boluses with a 20-minute lockout period). |
| Group C (CEI-group) | Active comparator | Drug: Epidural analgesia with bupivacaine and dexmedetomidineAfter the initial epidural loading dose of 10 ml, 30 patients will receive continuous epidural infusion (5 ml/h starting immediately after the loading dose) + patient controlled epidural analgesia (PCEA) as 5 ml boluses with a 20-minute lockout period). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18 - 45 years
- Scheduled for normal vaginal delivery
- ASA physical status ӀI-IӀӀ.
- Singleton non-complicated pregnancy.
- At least 36 weak of gestation.
Key exclusion criteria (9 listed)
- Patient refusal to epidural analgesia.
- History of cardiac, liver, or kidney diseases.
- History of allergy to amide local anesthetics or study medications.
- Any neurological problem.
- History of chronic opioid analgesic 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 |
|---|---|---|
| Epidural analgesia with bupivacaine and dexmedetomidineEpidural analgesia with bupivacaine and dexmedetomidine | Drug | Group C (CEI-group), Group P (PIEB-group) |
Primary outcome
total volume of local anesthetic
Time frame: 24 hour
total volume of local anesthetic received through patient controlled epidural analgesia per hour
5 secondary outcomes
Ramsay sedation scale
Time frame: 24 hour
Heart rate
Time frame: 24 hour
Blood Pressure
Time frame: 24 hour
Likert scale for satisfaction
Time frame: 24 hour
Bromage score for motor block
Time frame: 24 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- BackgroundEbirim, L.N., Buowari, O.Y., Ghosh, S. Physical and Psychological Aspects of Pain in Obstetrics. In: Ghosh, S., editor. Pain in Perspective [Internet]. London: IntechOpen; 2012 [cited 2022 Oct 18]. Available from: https://www.intechopen.com/chapters/40395 doi: 10.5772/53923
- BackgroundFortescue C, Wee MYK. Analgesia in labour: non-regional techniques. Continuing Education in Anaesthesia, Critical Care, and Pain. 2005; 5(1): 219-223.
- Background: PubMed 32333825Paramasivan A, Lopez-Olivo MA, Foong TW, Tan YW, Yap APA. Intrathecal dexmedetomidine and postoperative pain: A systematic review and meta-analysis of randomized controlled trials. Eur J Pain. 2020 Aug;24(7):1215-1227. doi: 10.1002/ejp.1575. Epub 2020 May 22.
- BackgroundVerghese T, Dixit N, John L, et al. Effect of intravenous dexmedetomidine on duration of spinal anaesthesia with hyperbaric bupivacaine - A comparative study. Indian J Clin Anaesth. 2019;6(1):97-101
- Background: PubMed 31461801Mostafa MF, Herdan R, Fathy GM, Hassan ZEAZ, Galal H, Talaat A, Ibrahim AK. Intrathecal dexmedetomidine versus magnesium sulphate for postoperative analgesia and stress response after caesarean delivery; randomized controlled double-blind study. Eur J Pain. 2020 Jan;24(1):182-191. doi: 10.1002/ejp.1476. Epub 2019 Sep 12.
- Background: PubMed 15189665Martin E, Ramsay G, Mantz J, Sum-Ping ST. The role of the alpha2-adrenoceptor agonist dexmedetomidine in postsurgical sedation in the intensive care unit. J Intensive Care Med. 2003 Jan-Feb;18(1):29-41. doi: 10.1177/0885066602239122.
- Background: PubMed 16369581Gertler R, Brown HC, Mitchell DH, Silvius EN. Dexmedetomidine: a novel sedative-analgesic agent. Proc (Bayl Univ Med Cent). 2001 Jan;14(1):13-21. doi: 10.1080/08998280.2001.11927725.
- Background: PubMed 19700777Werdehausen R, Fazeli S, Braun S, Hermanns H, Essmann F, Hollmann MW, Bauer I, Stevens MF. Apoptosis induction by different local anaesthetics in a neuroblastoma cell line. Br J Anaesth. 2009 Nov;103(5):711-8. doi: 10.1093/bja/aep236. Epub 2009 Aug 22.
- Background: PubMed 10027848Fairbanks CA, Wilcox GL. Spinal antinociceptive synergism between morphine and clonidine persists in mice made acutely or chronically tolerant to morphine. J Pharmacol Exp Ther. 1999 Mar;288(3):1107-16.
- Background: PubMed 28625301Sng BL, Sia ATH. Maintenance of epidural labour analgesia: The old, the new and the future. Best Pract Res Clin Anaesthesiol. 2017 Mar;31(1):15-22. doi: 10.1016/j.bpa.2017.01.002. Epub 2017 Jan 12.
- Background: PubMed 30882524Ojo OA, Mehdiratta JE, Gamez BH, Hunting J, Habib AS. Comparison of Programmed Intermittent Epidural Boluses With Continuous Epidural Infusion for the Maintenance of Labor Analgesia: A Randomized, Controlled, Double-Blind Study. Anesth Analg. 2020 Feb;130(2):426-435. doi: 10.1213/ANE.0000000000004104.
- Background: PubMed 17695343Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
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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.
Zein El-Abden Zareh Hassan, Professor study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Epidural analgesia with bupivacaine and dexmedetomidine in people with Labor Pain, run by Assiut 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 6 inclusion and 9 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 9 Apr 2024. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hassan Khaled Ahmed Gomaa, Resident (01067319365, hassssan.khaled2013@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total volume of local anesthetic (time frame: 24 hour). 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 NCT05781854, which also lists 13 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 9 Apr 2024.