Quality Health CareNCT06653036
Dural Puncture Epidural Vs Standard Epidural Technique in Parturient Receiving Continuous Labour Epidural Infusion
A study testing Dural puncture epidural and Standard Epidural Technique in people with Quality Health Care, run by Aga Khan University at 1 site in Pakistan.
Trial summary
The goal of this study is to evaluate the quality and safety of labor analgesia by comparing the use of Dural puncture epidural technique to Standard epidural technique while maintaining labor analgesia by means of continuous epidural infusion in parturient. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Quality Health Care
- What is being tested?
- Dural puncture epidural and Standard Epidural Technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Nov 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Nulliparous / Multiparous women
- Age >18 years
- ASA 1 \& 2
- Singleton vertex presentation
- Gestational age 37-42 weeks
- Parturient with established labor and pain score ≥ 3
Who cannot join
- Major cardiac disease
- History of chronic pain
- Chronic opioid user
- Platelet count < 70 x 109/L
- spinal cord anomalies
- Use of anticoagulants
Show all 9Show fewer
- Allergic to local anesthetics
- Patients with preeclampsia/ eclampsia
- Known fetal anomalies
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Aga Khan University
Karachi, Sindh
Samina Ismail, MBBS, FCPS, +922134854331 ext. 4331, samina.ismail@aku.edu
About this study
Official title: Dural Puncture Epidural Vs Standard Epidural Technique in Parturient Receiving Continuous Labour Epidural Infusion: a Randomized Controlled Trial
The goal of this study is to evaluate the quality and safety of labor analgesia by comparing the use of Dural puncture epidural technique to Standard epidural technique while maintaining labor analgesia by means of continuous epidural infusion in parturient. The main questions it aims to answer are
- Effectiveness and quality of labor analgesia
- Frequency of catheter adjustments
- Need for catheter replacements
- Incidence of failed regional anesthesia requiring conversion to general anesthesia
- Conditions
- Quality Health Care
- Being tested
- Dural puncture epidural, Standard Epidural Technique
- Keywords
- Quality Labor Analgesia, Maternal Adverse Events
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dural puncture epiduralProcedure or surgery
The Dural puncture epidural technique is done by assessing the epidural space using the Touhy needle and puncturing the dura matter with a finer needle.
Standard Epidural TechniqueProcedure or surgery
The Standard Epidural Technique is usually performed by identifying the epidural space using the loss of resistance technique and threading the epidural catheter in the epidural space for administration of analgesic drugs.
| Study group | Role | What they receive |
|---|---|---|
| DPE group | Active comparator | Participants who receive the dural puncture epidural (DPE) for labor analgesia. Receives: Procedure: Dural puncture epidural |
| SET group | Active comparator | Participants who will be receiving standard epidural technique (SET) for labor analgesia. Receives: Procedure: Standard Epidural Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Assessment
Pain assessment by using numerical rating pain score and assessing sensory level. Numerical rating score: Pain Assessment: Numerical rating scale (NRS) 0 to 10. 0=no pain, 1-3 =mild pain, 4-7 =Moderate pain, 8-10= severe pain. Assessing sensory level: Testing will be done on specific dermatomes and will be compared bilaterally by either using one of these tests. 1. Light Touch Test: Dab a piece of cotton wool on an area of skin. 2. Temperature test: by using Ice on specific dermatomes and ask the patient if they feel cold sensation 3. Pinprick Test for pain sensation - Gently touch the skin with the pin ask the patient whether it feels sharp or blunt.
Measured: At 30 minutes of initiation of infusion
Need for catheter adjustment
Persistence of either unilateral pain score (NRS) of >4, thirty minutes after 2 boluses of 10ml of 0.125% Bupivacaine
Measured: At 30 minutes of initiation of infusion
Secondary outcomes (2)
Patient Satisfaction
Patient Satisfaction using a five-point satisfaction score as follows:
Satisfied (score 1 to 3) ------------- Unsatisfied (score 4 to 5) -----------
- perfect: the patient did not experience any pain at all,
- very satisfied: helped relieve most of her pains,
- satisfied: the epidural procedure relieved major pains, but she still experienced minor pains,
- 4not satisfied: the epidural procedure helped only a bit a
- poor: the epidural procedure did not help at all. Scores from 1 to 3 were considered as the patient being satisfied with the labour epidural analgesia, and scores from 4 to 5 were regarded as the patient being unsatisfied with the labour epidural analgesia.
Measured: At 30 minutes of initiation of infusion
Assessment of the level of motor Block
The level of the motor block will be assessed using the modified Bromage score. Where, 1 =unable to flex feet or knees, 2 =able to flex feet only, 3 =s able to flex knees, 4 = detectable weakness in hip flexion, 5 = no weakness with hip flexion
Measured: At 30 minutes after the initiation of infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start28 Nov 2024
- Primary completion30 Nov 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality Health CareStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samina Ismail, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06653036
- Sponsor's protocol ID
- 2024-10424-31009
- Status last verified
- Jan 2025
- First submitted
- 26 Sep 2024
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dural Puncture Epidural Vs Standard Epidural Technique in Parturient Receiving Continuous Labour Epidural Infusion: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06653036
- Acronym / sponsor ID
- 2024-10424-31009
- Conditions
- Quality Health Care
- Keywords
- Quality Labor Analgesia, Maternal Adverse Events
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- 28 Nov 2024 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 22 Oct 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.
The goal of this study is to evaluate the quality and safety of labor analgesia by comparing the use of Dural puncture epidural technique to Standard epidural technique while maintaining labor analgesia by means of continuous epidural infusion in parturient. The main questions it aims to answer are
- Effectiveness and quality of labor analgesia
- Frequency of catheter adjustments
- Need for catheter replacements
- Incidence of failed regional anesthesia requiring conversion to general anesthesia
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DPE group | Active comparator | Procedure: Dural puncture epiduralParticipants who receive the dural puncture epidural (DPE) for labor analgesia. |
| SET group | Active comparator | Procedure: Standard Epidural TechniqueParticipants who will be receiving standard epidural technique (SET) for labor analgesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Nulliparous / Multiparous women
- Age >18 years
- ASA 1 \& 2
- Singleton vertex presentation
- Gestational age 37-42 weeks
Key exclusion criteria (9 listed)
- Major cardiac disease
- History of chronic pain
- Chronic opioid user
- Platelet count < 70 x 109/L
- spinal cord anomalies
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 |
|---|---|---|
| Dural puncture epiduralThe Dural puncture epidural technique is done by assessing the epidural space using the Touhy needle and puncturing the dura matter with a finer needle. | Procedure or surgery | DPE group |
| Standard Epidural TechniqueThe Standard Epidural Technique is usually performed by identifying the epidural space using the loss of resistance technique and threading the epidural catheter in the epidural space for administration of analgesic drugs. | Procedure or surgery | SET group |
Primary outcome
Pain Assessment
Time frame: At 30 minutes of initiation of infusion
Pain assessment by using numerical rating pain score and assessing sensory level. Numerical rating score: Pain Assessment: Numerical rating scale (NRS) 0 to 10. 0=no pain, 1-3 =mild pain, 4-7 =Moderate pain, 8-10= severe pain. Assessing sensory level: Testing will be done on specific dermatomes and will be compared bilaterally by either using one of these tests. 1. Light Touch Test: Dab a piece of cotton wool on an area of skin. 2. Temperature test: by using Ice on specific dermatomes and ask the patient if they feel cold sensation 3. Pinprick Test for pain sensation - Gently touch the skin with the pin ask the patient whether it feels sharp or blunt.
Need for catheter adjustment
Time frame: At 30 minutes of initiation of infusion
Persistence of either unilateral pain score (NRS) of >4, thirty minutes after 2 boluses of 10ml of 0.125% Bupivacaine
2 secondary outcomes
Patient Satisfaction
Time frame: At 30 minutes of initiation of infusion
Assessment of the level of motor Block
Time frame: At 30 minutes after the initiation of infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dural puncture epidural and Standard Epidural Technique in people with Quality Health Care, run by Aga Khan University at 1 site in Pakistan.
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: looking for participants now, as of the sponsor's last update on 30 Jan 2025. 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 Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samina Ismail, MBBS, FCPS (+922134864331 ext. 4331, samina.ismail@aku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Assessment (time frame: At 30 minutes of initiation of infusion). The study lists 2 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 30 Jan 2025.