Labor PainNCT06392321
Dexmedetomidine vs Fentanyl in Controlling Labor Pain
A study testing Fentanyl and Dexmedetomidine in people with Labor Pain, run by Al-Azhar University at 1 site in Egypt.
Trial summary
As most woman experience agonizing pain throughout vaginal labor. Adjuvants were added to intrathecal bupivacaine aiming to improve the quality of analgesia. This study aimed to assess the efficacy and outcome of intrathecal dexmedetomidine and fentanyl in controlling pain during delivery. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Labor Pain
- What is being tested?
- Fentanyl and Dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2023to 31 Dec 2023
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women planned for spontaneous vaginal delivery.
Who cannot join
- cardiac, liver or kidney disease, allergy to local anesthetics or the studied drugs, any contraindication of regional anesthesia and intrauterine growth retardation or fetal compromise.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dexmedetomidine Versus Fentanyl as an Adjuvant to Single Low Dose Spinal Anesthesia in Controlling Labor Pain: a Randomized Controlled Study
As most woman experience agonizing pain throughout vaginal labor. Adjuvants were added to intrathecal bupivacaine aiming to improve the quality of analgesia. This study aimed to assess the efficacy and outcome of intrathecal dexmedetomidine and fentanyl in controlling pain during delivery.
Read the detailed description
Throughout vaginal deliveries, many women suffered from pain. providing suitable analgesia is crucial (Lupu et al., 2023). Spinal anesthesia can provide pain management (Parikh et al., 2018).
Various types of analgesics can be combined to get the needed duration of perioperative analgesia. Dexmedetomidine has been used with effective pain management outcomes (Shrestha et al., 2023). Fentanyl can help pain relief in short duration procedures (Show et al., 2022).
- Conditions
- Labor Pain
- Being tested
- Fentanyl, Dexmedetomidine
- Keywords
- Dexmedetomidine, Fentanyl, intrathecal, labor pain
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
comparison between bupivacaine, bupivacaine and fentanyl.
DexmedetomidineDrug
comparison between bupivacaine, bupivacaine and dexmedetomidine..
| Study group | Role | What they receive |
|---|---|---|
| Fentanyl | Active comparator | Bupivacaine 3,75 mg + 2.5 ml saline added to fentanyl 20 microgram + 2.3 ml saline Receives: Drug: Fentanyl |
| Dexmedetomidine | Active comparator | Bupivacaine 3,75 mg + 2.5 ml saline added to dexmedetomedine 5 microgram + 2.3 ml saline Receives: Drug: Dexmedetomidine |
| control | No intervention | Bupivacaine 3,75 mg + 2.5 ml saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy of intrathecal dexmedetomidine
VAS
Measured: 120 minutes
Secondary outcomes (2)
patient satisfaction
satisfaction score
Measured: 2 hours
mother's outocme
APGAR
Measured: 1 and 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start1 Apr 2023
- Primary completion30 Nov 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 Al-Azhar 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ismail Mohamed Abdelgawad Ahmed, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06392321
- Sponsor's protocol ID
- controlling labor pain
- Status last verified
- Apr 2024
- First submitted
- 26 Apr 2024
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD are planned to be coded for privacy protection.
Publications
Lupu VV, Miron IC, Raileanu AA, Starcea IM, Lupu A, Tarca E, Mocanu A, Buga AML, Lupu V, Fotea S. Difficulties in Adaptation of the Mother and Newborn via Cesarean Section versus Natural Birth-A Narrative Review. Life (Basel). 2023 Jan 21;13(2):300. doi: 10.3390/life13020300.
PubMed 36836657Parikh KS, Seetharamaiah S. Approach to failed spinal anaesthesia for caesarean section. Indian J Anaesth. 2018 Sep;62(9):691-697. doi: 10.4103/ija.IJA_457_18.
PubMed 30237594Shrestha IK, Chalise R, Poudel S, Regmi A, Ghimire A, Khadka B, Khanal K. Neostigmine and atropine as a treatment for postdural puncture headache after spinal anesthesia in cesarean section: A case report. Clin Case Rep. 2023 Nov 2;11(11):e8132. doi: 10.1002/ccr3.8132. eCollection 2023 Nov.
PubMed 37927977Show KL, Ngamjarus C, Kongwattanakul K, Rattanakanokchai S, Duangkum C, Bohren MA, Betran AP, Somjit M, Win WYH, Lumbiganon P. Fentanyl for labour pain management: a scoping review. BMC Pregnancy Childbirth. 2022 Nov 17;22(1):846. doi: 10.1186/s12884-022-05169-x.
PubMed 36397024
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine Versus Fentanyl as an Adjuvant to Single Low Dose Spinal Anesthesia in Controlling Labor Pain: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06392321
- Acronym / sponsor ID
- controlling labor pain
- Conditions
- Labor Pain
- Keywords
- Dexmedetomidine, Fentanyl, intrathecal, labor pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 30 Apr 2024 (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.
As most woman experience agonizing pain throughout vaginal labor. Adjuvants were added to intrathecal bupivacaine aiming to improve the quality of analgesia. This study aimed to assess the efficacy and outcome of intrathecal dexmedetomidine and fentanyl in controlling pain during delivery.
Detailed description
Throughout vaginal deliveries, many women suffered from pain. providing suitable analgesia is crucial (Lupu et al., 2023). Spinal anesthesia can provide pain management (Parikh et al., 2018).
Various types of analgesics can be combined to get the needed duration of perioperative analgesia. Dexmedetomidine has been used with effective pain management outcomes (Shrestha et al., 2023). Fentanyl can help pain relief in short duration procedures (Show et al., 2022).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fentanyl | Active comparator | Drug: FentanylBupivacaine 3,75 mg + 2.5 ml saline added to fentanyl 20 microgram + 2.3 ml saline |
| Dexmedetomidine | Active comparator | Drug: DexmedetomidineBupivacaine 3,75 mg + 2.5 ml saline added to dexmedetomedine 5 microgram + 2.3 ml saline |
| control | No intervention | –Bupivacaine 3,75 mg + 2.5 ml saline |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- women planned for spontaneous vaginal delivery.
Key exclusion criteria (1 listed)
- cardiac, liver or kidney disease, allergy to local anesthetics or the studied drugs, any contraindication of regional anesthesia and intrauterine growth retardation or fetal compromise.
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 |
|---|---|---|
| Fentanylcomparison between bupivacaine, bupivacaine and fentanyl. | Drug | Fentanyl |
| Dexmedetomidinecomparison between bupivacaine, bupivacaine and dexmedetomidine.. | Drug | Dexmedetomidine |
Primary outcome
efficacy of intrathecal dexmedetomidine
Time frame: 120 minutes
VAS
2 secondary outcomes
patient satisfaction
Time frame: 2 hours
mother's outocme
Time frame: 1 and 5 minutes
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 30 Apr 2024.
- Background: PubMed 36836657Lupu VV, Miron IC, Raileanu AA, Starcea IM, Lupu A, Tarca E, Mocanu A, Buga AML, Lupu V, Fotea S. Difficulties in Adaptation of the Mother and Newborn via Cesarean Section versus Natural Birth-A Narrative Review. Life (Basel). 2023 Jan 21;13(2):300. doi: 10.3390/life13020300.
- Background: PubMed 30237594Parikh KS, Seetharamaiah S. Approach to failed spinal anaesthesia for caesarean section. Indian J Anaesth. 2018 Sep;62(9):691-697. doi: 10.4103/ija.IJA_457_18.
- Background: PubMed 37927977Shrestha IK, Chalise R, Poudel S, Regmi A, Ghimire A, Khadka B, Khanal K. Neostigmine and atropine as a treatment for postdural puncture headache after spinal anesthesia in cesarean section: A case report. Clin Case Rep. 2023 Nov 2;11(11):e8132. doi: 10.1002/ccr3.8132. eCollection 2023 Nov.
- Background: PubMed 36397024Show KL, Ngamjarus C, Kongwattanakul K, Rattanakanokchai S, Duangkum C, Bohren MA, Betran AP, Somjit M, Win WYH, Lumbiganon P. Fentanyl for labour pain management: a scoping review. BMC Pregnancy Childbirth. 2022 Nov 17;22(1):846. doi: 10.1186/s12884-022-05169-x.
- Individual participant dataSharing planned: No. IPD are planned to be coded for privacy protection.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fentanyl and Dexmedetomidine in people with Labor Pain, run by Al-Azhar 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 1 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: finished, as of the sponsor's last update on 30 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.
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?
efficacy of intrathecal dexmedetomidine (time frame: 120 minutes). 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 NCT06392321, which also lists 4 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 30 Apr 2024.