Gynecologic Disease Requiring Laparoscopic Hysterectomy Under Neuraxial AnesthesiaNCT05032677
Dural Puncture Epidural Technique Versus Conventional Epidural Techmique
A study testing Conventional Epidural Technique and Dural Puncture Epidural Technique using pencil-point 25G Whitacre needle in people with Gynecologic Disease Requiring Laparoscopic Hysterectomy Under Neuraxial Anesthesia, run by Cairo University at 1 site in Egypt.
Trial summary
This study will be conducted on 50 patients of ASA grade I and II aged from 25 to 55 years and presented for laparoscopic hysterectomy. Patients will be divided into two equal groups; group A control group for conventional epidural technique(n=25) and group B for 25G dural puncture epidural with 25G pencil point… Read more about this study
- Who is it for?
- Ages 25 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gynecologic Disease Requiring Laparoscopic Hysterectomy Under Neuraxial Anesthesia
- What is being tested?
- Conventional Epidural Technique and Dural Puncture Epidural Technique using pencil-point 25G Whitacre needle
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Aug 2021to 10 Dec 2022
- 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 25 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- ASA I and II
- Height(150-170 cm)
Who cannot join
- patient refusal
- hypersensitivity to local anesthetic drugs
- bleeding disorders and coagulopathy(platelets count less than 80000,INR less than 1.5 or therapeutic dose of anticoagulant).
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Department of Anesthesia, Surgical ICU, and Pain Management
Cairo, 11562
About this study
Official title: Comparative Study Between Dural Puncture Epidural Technique Versus Conventional Epidural Technique During Laparoscopic Hysterectomy
This study will be conducted on 50 patients of ASA grade I and II aged from 25 to 55 years and presented for laparoscopic hysterectomy. Patients will be divided into two equal groups; group A control group for conventional epidural technique(n=25) and group B for 25G dural puncture epidural with 25G pencil point Whitacre spinal needle (n=25). Randomization will be done using computer generated number and concealed using sequentially numbered, sealed opaque envelope.
- Being tested
- Conventional Epidural Technique, Dural Puncture Epidural Technique using pencil-point 25G Whitacre needle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Epidural TechniqueProcedure or surgery
Standard Lumbar Epidural Block using Touhy Epidural Needle (18G) at L2-3 inter-space and Epidural Catheter (20G) was inserted then bupivacaine 0.5% 15-20 ml with 50ug fentanyl was given.
Dural Puncture Epidural Technique using pencil-point 25G Whitacre needleProcedure or surgery
25G Dural Puncture Epidural Block at L2-3 inter-space then bupivacaine 0.5% 15-20 ml with 50ug fentanyl was given.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Epidural Technique | Experimental | Not described Receives: Procedure: Dural Puncture Epidural Technique using pencil-point 25G Whitacre needle |
| Dural Puncture Epidural technique using pencil-point 25G Whitacre needle | Active comparator | Not described Receives: Procedure: Conventional Epidural Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of bilateral sacral blockade
Sensory blockade was evaluated using a non-traumatic pinprick stimulus starting at the S2 dermatome and moving in a caudad direction (measured every 2 minutes)
Measured: Up to 30 minutes after local anesthetic injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start18 Aug 2021
- Primary completion2 Nov 2022
- Study completion10 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic Disease Requiring Laparoscopic Hysterectomy Under Neuraxial AnesthesiaStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham Ali Abdelhaleem Abdelrahman, Cairo University
- Investigators
- Reham Ali Abdelrahman, M.D., Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05032677
- Sponsor's protocol ID
- ES-2022
- Status last verified
- Dec 2022
- First submitted
- 27 Aug 2021
- Last updated
- 15 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Dural Puncture Epidural Technique Versus Conventional Epidural Technique During Laparoscopic Hysterectomy
- ClinicalTrials.gov ID
- NCT05032677
- Acronym / sponsor ID
- ES-2022
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 18 Aug 2021 (actual)
- Primary completion
- 2 Nov 2022 (actual)
- Study completion
- 10 Dec 2022 (actual)
- First posted
- 2 Sep 2021 (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.
This study will be conducted on 50 patients of ASA grade I and II aged from 25 to 55 years and presented for laparoscopic hysterectomy. Patients will be divided into two equal groups; group A control group for conventional epidural technique(n=25) and group B for 25G dural puncture epidural with 25G pencil point Whitacre spinal needle (n=25). Randomization will be done using computer generated number and concealed using sequentially numbered, sealed opaque envelope.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Epidural Technique | Experimental | Procedure: Dural Puncture Epidural Technique using pencil-point 25G Whitacre needle |
| Dural Puncture Epidural technique using pencil-point 25G Whitacre needle | Active comparator | Procedure: Conventional Epidural Technique |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- ASA I and II
- Height(150-170 cm)
Key exclusion criteria (3 listed)
- patient refusal
- hypersensitivity to local anesthetic drugs
- bleeding disorders and coagulopathy(platelets count less than 80000,INR less than 1.5 or therapeutic dose of anticoagulant).
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 |
|---|---|---|
| Conventional Epidural TechniqueStandard Lumbar Epidural Block using Touhy Epidural Needle (18G) at L2-3 inter-space and Epidural Catheter (20G) was inserted then bupivacaine 0.5% 15-20 ml with 50ug fentanyl was given. | Procedure or surgery | Dural Puncture Epidural technique using pencil-point 25G Whitacre needle |
| Dural Puncture Epidural Technique using pencil-point 25G Whitacre needle25G Dural Puncture Epidural Block at L2-3 inter-space then bupivacaine 0.5% 15-20 ml with 50ug fentanyl was given. | Procedure or surgery | Conventional Epidural Technique |
Primary outcome
incidence of bilateral sacral blockade
Time frame: Up to 30 minutes after local anesthetic injection
Sensory blockade was evaluated using a non-traumatic pinprick stimulus starting at the S2 dermatome and moving in a caudad direction (measured every 2 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 15 Dec 2022.
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.
Reham Ali Abdelrahman, M.D. principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Epidural Technique and Dural Puncture Epidural Technique using pencil-point 25G Whitacre needle in people with Gynecologic Disease Requiring Laparoscopic Hysterectomy Under Neuraxial Anesthesia, run by Cairo 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 3 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 Dec 2022. 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?
incidence of bilateral sacral blockade (time frame: Up to 30 minutes after local anesthetic injection). 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 Dec 2022.