Gynecologic Disease Requiring Vaginal Operation Under Neuraxial AnesthesiaNCT03790748
Regional Blocks of Gynecological Surgeries
A study testing Standard Lumbar Epidural Technique, 25G Dural Puncture Epidural Technique and 27G Dural Puncture Epidural Technique in people with Gynecologic Disease Requiring Vaginal Operation Under Neuraxial Anesthesia, run by Cairo University at 2 sites in Egypt.
Trial summary
This study will be conducted on 273 patients of ASA grade I and II aged from 25 to 55 years and presented for elective vaginal surgeries such as vaginal hysterectomy, repair of prolapse Patients will be divided into three equal groups; group A control group for conventional epidural technique(n=91), group B for dural… 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 Vaginal Operation Under Neuraxial Anesthesia
- What is being tested?
- Standard Lumbar Epidural Technique, 25G Dural Puncture Epidural Technique and 27G Dural Puncture Epidural Technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 273 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Feb 2019to 31 Jul 2021
- 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
2 sites in 1 country.
Egypt2 sites
Department of Anesthesia, Surgical ICU, and Pain Management
Cairo, 11562
Reham Ali Abdelrahman
Cairo, 11562
About this study
Official title: Comparison of Dural Puncture Epidural Technique Versus Conventional Epidural Technique for Adequate Anesthesia During Vaginal Surgeries
This study will be conducted on 273 patients of ASA grade I and II aged from 25 to 55 years and presented for elective vaginal surgeries such as vaginal hysterectomy, repair of prolapse Patients will be divided into three equal groups; group A control group for conventional epidural technique(n=91), group B for dural puncture epidural with 27G pencil point Whitacre spinal needle (n=91) and group C for dural puncture epidural with 25G pencil point Whitacre spinal needle(n=91). Randomization will be done using computer generated number and concealed using sequentially numbered sealed opaque envelope.
- Being tested
- Standard Lumbar Epidural Technique, 25G Dural Puncture Epidural Technique, 27G Dural Puncture Epidural Technique
- Keywords
- Neuraxial Technique, Epidural Technique, Dural Puncture Epidural Technique, Gynecologic Disease
- Medical subject headings
- Genital Diseases, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Lumbar Epidural TechniqueProcedure or surgery
Standard Lumbar Epidural Technique at L4-5 inter-space using 0.5%Bupivacaine and Fentanyl.
25G Dural Puncture Epidural TechniqueProcedure or surgery
25G Dural Puncture Epidural Technique at L4-5 inter-space using 0.5%Bupivacaine and Fentanyl.
27G Dural Puncture Epidural TechniqueProcedure or surgery
27G Dural Puncture Epidural Technique at L4-5 inter-space using 0.5%Bupivacaine and Fentanyl.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Epidural Technique | Experimental | Procedure: Standard Lumbar Epidural Block using Touhy Epidural Needle (18G) at L4-5 inter-space and Epidural Catheter (20G) was inserted then bupivacaine 0.5% 15-20 ml with 50ug fentanyl was given. Receives: Procedure: 25G Dural Puncture Epidural Technique; Procedure: 27G Dural Puncture Epidural Technique |
| Dural Puncture Epidural Technique using pencil-point 25G Whitacre needle | Active comparator | Procedure: 25G Dural Puncture Epidural Block at L4-5 inter-space then bupivacaine 0.5% 15-20 ml with 50ug fentanyl was given. Receives: Procedure: Standard Lumbar Epidural Technique; Procedure: 27G Dural Puncture Epidural Technique |
| Dural Puncture Epidural Technique using pencil-point 27G Whitacre needle | Active comparator | Procedure: 27G Dural Puncture Epidural Block at L4-5 inter-space then bupivacaine 0.5% 15-20 ml with 50ug fentanyl was given. Receives: Procedure: Standard Lumbar Epidural Technique; Procedure: 25G Dural Puncture 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
Secondary outcomes (12)
Onset of sensory blockade
Measured: Up to 30 minutes after local anesthetic injection
Maximum achieved sensory level
Measured: Up to 30 minutes after local anesthetic injection
Time to achieve the maximum sensory level
Measured: Up to 30 minutes after local anesthetic injection
Onset of motor blockade
Measured: Up to 30 minutes after local anesthetic injection
Time to complete motor block
Measured: Up to 30 minutes after local anesthetic injection
Duration of sensory block
Time to two segmental dermatomes regression
Measured: Assessed every 20 minutes after achieving highest dermatome level of sensory analgesia
Duration of motor block
Time interval from achievement of Bromage 1 to regression of motor blockade to Bromage 1
Measured: Assessed every 20 minutes after achieving Bromage 3 motor block
Duration of analgesia
Time from onset of sensory block to first complain of pain postoperatively as the epidural catheter will be removed after the surgery finished
Measured: Time for requirement for rescue analgesia or VAS pain score >3 as postoperatively
Number of epidural top-ups
Measured: Number of extra doses of local anesthetic given after injection of local anesthetic loading dose till end of the surgery
Sedation score
Measured: Assessed every 20 minutes during the surgical procedure and postoperatively
Hemodynamic parameters
Measured: Assessed every 5 minutes from the start of anesthetic procedures till transfer the patients to the rooms
Perioperative side effects
Measured: During surgical period up to 7 days post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2019
- Study start1 Feb 2019
- Primary completion28 Jun 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic Disease Requiring Vaginal Operation 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
- 273 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
- NCT03790748
- Sponsor's protocol ID
- IUD2900
- Status last verified
- Aug 2021
- First submitted
- 23 Dec 2018
- Last updated
- 1 Sep 2021
- 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 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Dural Puncture Epidural Technique Versus Conventional Epidural Technique for Adequate Anesthesia During Vaginal Surgeries
- ClinicalTrials.gov ID
- NCT03790748
- Acronym / sponsor ID
- IUD2900
- Keywords
- Neuraxial Technique, Epidural Technique, Dural Puncture Epidural Technique, Gynecologic Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 273 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 28 Jun 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 2 Jan 2019 (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 273 patients of ASA grade I and II aged from 25 to 55 years and presented for elective vaginal surgeries such as vaginal hysterectomy, repair of prolapse Patients will be divided into three equal groups; group A control group for conventional epidural technique(n=91), group B for dural puncture epidural with 27G pencil point Whitacre spinal needle (n=91) and group C for dural puncture epidural with 25G pencil point Whitacre spinal needle(n=91). 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
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional Epidural Technique | Experimental | Procedure: 25G Dural Puncture Epidural Technique, Procedure: 27G Dural Puncture Epidural TechniqueProcedure: Standard Lumbar Epidural Block using Touhy Epidural Needle (18G) at L4-5 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 needle | Active comparator | Procedure: Standard Lumbar Epidural Technique, Procedure: 27G Dural Puncture Epidural TechniqueProcedure: 25G Dural Puncture Epidural Block at L4-5 inter-space then bupivacaine 0.5% 15-20 ml with 50ug fentanyl was given. |
| Dural Puncture Epidural Technique using pencil-point 27G Whitacre needle | Active comparator | Procedure: Standard Lumbar Epidural Technique, Procedure: 25G Dural Puncture Epidural TechniqueProcedure: 27G Dural Puncture Epidural Block at L4-5 inter-space then bupivacaine 0.5% 15-20 ml with 50ug fentanyl was given. |
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 |
|---|---|---|
| Standard Lumbar Epidural TechniqueStandard Lumbar Epidural Technique at L4-5 inter-space using 0.5%Bupivacaine and Fentanyl. | Procedure or surgery | Dural Puncture Epidural Technique using pencil-point 25G Whitacre needle, Dural Puncture Epidural Technique using pencil-point 27G Whitacre needle |
| 25G Dural Puncture Epidural Technique25G Dural Puncture Epidural Technique at L4-5 inter-space using 0.5%Bupivacaine and Fentanyl. | Procedure or surgery | Conventional Epidural Technique, Dural Puncture Epidural Technique using pencil-point 27G Whitacre needle |
| 27G Dural Puncture Epidural Technique27G Dural Puncture Epidural Technique at L4-5 inter-space using 0.5%Bupivacaine and Fentanyl. | Procedure or surgery | Conventional Epidural Technique, Dural Puncture Epidural Technique using pencil-point 25G Whitacre needle |
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)
12 secondary outcomes
Onset of sensory blockade
Time frame: Up to 30 minutes after local anesthetic injection
Maximum achieved sensory level
Time frame: Up to 30 minutes after local anesthetic injection
Time to achieve the maximum sensory level
Time frame: Up to 30 minutes after local anesthetic injection
Onset of motor blockade
Time frame: Up to 30 minutes after local anesthetic injection
Time to complete motor block
Time frame: Up to 30 minutes after local anesthetic injection
Duration of sensory block
Time frame: Assessed every 20 minutes after achieving highest dermatome level of sensory analgesia
Duration of motor block
Time frame: Assessed every 20 minutes after achieving Bromage 3 motor block
Duration of analgesia
Time frame: Time for requirement for rescue analgesia or VAS pain score >3 as postoperatively
Number of epidural top-ups
Time frame: Number of extra doses of local anesthetic given after injection of local anesthetic loading dose till end of the surgery
Sedation score
Time frame: Assessed every 20 minutes during the surgical procedure and postoperatively
Hemodynamic parameters
Time frame: Assessed every 5 minutes from the start of anesthetic procedures till transfer the patients to the rooms
Perioperative side effects
Time frame: During surgical period up to 7 days post-operatively
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 1 Sep 2021.
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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Lumbar Epidural Technique, 25G Dural Puncture Epidural Technique and 27G Dural Puncture Epidural Technique in people with Gynecologic Disease Requiring Vaginal Operation Under Neuraxial Anesthesia, run by Cairo University at 2 sites 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 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 1 Sep 2021.