Dural Puncture Epidural AnesthesiaNCT06507397
Dural Puncture Epidural Anesthesia Versus Traditional Spinal Anesthesia for Rigid Cystoscopy
A study testing hyperbaric bupivacaine and fentanyl and plain bupivacaine and fentanyl in people with Dural Puncture Epidural Anesthesia and Spinal Anesthesia, run by Tanta University at 1 site in Egypt.
Trial summary
The main objective of this study was to determine if the dural puncture epidural (DPE) anesthesia provides superior analgesia and better patient satisfaction when compared to traditional spinal anesthesia for rigid cystoscopy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dural Puncture Epidural Anesthesia, Spinal Anesthesia, Rigid Cystoscopy
- What is being tested?
- hyperbaric bupivacaine and fentanyl and plain bupivacaine and fentanyl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2022to 1 Mar 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- Both sex.
- American Society of Anesthesiology (ASA) physical status I, II, III.
- Admitted for elective rigid cystoscopy.
Who cannot join
- Refusal of patients.
- Body Mass Index (BMI) > 35.
- Patients who have history of substance abuse.
- Patients with difficult communication.
- Contraindication to neuraxial anesthesia (e.g.; infection near the site of injection, coagulopathy or bleeding disorder).
- Patients with history of allergy to local anesthetics.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dural Puncture Epidural Anesthesia Versus Traditional Spinal Anesthesia for Rigid Cystoscopy: A Randomized Controlled Trial
The main objective of this study was to determine if the dural puncture epidural (DPE) anesthesia provides superior analgesia and better patient satisfaction when compared to traditional spinal anesthesia for rigid cystoscopy.
Read the detailed description
Most urologic surgeries are performed in a narrow and limited space with the minimally invasive technique or cystoscope, and most patients undergoing urologic surgeries are elderly individuals with other diseases.
Cystoscopic evaluation of the lower urinary tract is a vital part of an office-based urologic practice. However, regular surveillance cystoscopy is a significant source of morbidity for patients, and therefore attempts have been made to minimize discomfort secondary to this procedure.
Spinal anesthesia is popular for endoscopic urological surgery because of early recognition of symptoms caused by overhydration, transurethral resection of prostate (TURP) syndrome and bladder perforation.
The dural puncture epidural (DPE) technique is a modification of the combined spinal epidural (CSE) technique, where a dural perforation is created from a spinal needle but intrathecal medication administration is withheld. The DPE technique has been shown to improve caudal spread of analgesia compared with epidural (EPL) technique without the side effects observed with the CSE technique.
- Being tested
- hyperbaric bupivacaine and fentanyl, plain bupivacaine and fentanyl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hyperbaric bupivacaine and fentanylDrug
Also called Spinal Anesthesia
Patients received 3ml hyperbaric bupivacaine 0.5% combined with 25 microg of fentanyl.
plain bupivacaine and fentanylDrug
Also called Dural Puncture Epidural Anesthesia
Patients received 15 mL mixture of (0.25% plain bupivacaine and 50 µg fentanyl) over 5 minutes, injected in the epidural space by epidural catheter at L3-L4 interspace, a dural puncture was created by the spinal needle. Braun's Espocan® combined spinal epidural kit before insertion of epidural catheter (needle-through-needle technique) but intrathecal medication administration was withheld.
| Study group | Role | What they receive |
|---|---|---|
| Spinal Anesthesia | Active comparator | Patients received 3-ml hyperbaric bupivacaine 0.5% and 25 mcg fentanyl (0.5-ml). Receives: Drug: hyperbaric bupivacaine and fentanyl |
| Dural Puncture Epidural Anesthesia | Experimental | Patients received 15-ml mixture of bupivacaine 0.25% and 50 mcg fentanyl over 5 minutes , injected in the epidural space by epidural catheter at L3-L4 interspace, a dural puncture was created by the spinal needle. Braun's Espocan® combined spinal epidural kit before insertion of epidural catheter (needle-through-needle technique) but intrathecal medication administration was withheld. Receives: Drug: plain bupivacaine and fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the onset of anesthesia
Assessment of the onset by test sensory loss at T10 by pin prick using sterile needle with blunt edge (defined as time from end of injection of bolus dose to 1st sign of sensory block at T10).
Sensory level of the techniques which was assessed at 2 min after end of injection of the drug then every 5 min till the 30 min then every 15 min till end of the surgery.
Measured: Every 15 minutes till end of the surgery
Secondary outcomes (3)
Time of onset of motor block
Time of onset of motor block was assessed from end of drug injection to time of achieving Breen Modified Bromage scale (BMBS) grade 1) in the lower extremities was assessed by using a BMBS: Grade 1 as complete motor block to Grade 6 as no motor block) and it was assessed at 2 min then every 3 min after injection of the drug till 30 min then every 15 min till the end of the surgery.
Measured: Till the end of the surgery
Incidence of side effects
Incidence of side effects such as (hypotension and bradycardia) were recorded.
Measured: 24 hours postoperatively
Number of patients required rescue analgesia
Number of patients required rescue analgesia was measured.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start1 Oct 2022
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dural Puncture Epidural AnesthesiaStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rabab Mohamed Mohamed Mohamed, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06507397
- Sponsor's protocol ID
- 35621/8/22
- Status last verified
- Jul 2024
- First submitted
- 11 Jul 2024
- Last updated
- 18 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dural Puncture Epidural Anesthesia Versus Traditional Spinal Anesthesia for Rigid Cystoscopy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06507397
- Acronym / sponsor ID
- 35621/8/22
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 18 Jul 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 main objective of this study was to determine if the dural puncture epidural (DPE) anesthesia provides superior analgesia and better patient satisfaction when compared to traditional spinal anesthesia for rigid cystoscopy.
Detailed description
Most urologic surgeries are performed in a narrow and limited space with the minimally invasive technique or cystoscope, and most patients undergoing urologic surgeries are elderly individuals with other diseases.
Cystoscopic evaluation of the lower urinary tract is a vital part of an office-based urologic practice. However, regular surveillance cystoscopy is a significant source of morbidity for patients, and therefore attempts have been made to minimize discomfort secondary to this procedure.
Spinal anesthesia is popular for endoscopic urological surgery because of early recognition of symptoms caused by overhydration, transurethral resection of prostate (TURP) syndrome and bladder perforation.
The dural puncture epidural (DPE) technique is a modification of the combined spinal epidural (CSE) technique, where a dural perforation is created from a spinal needle but intrathecal medication administration is withheld. The DPE technique has been shown to improve caudal spread of analgesia compared with epidural (EPL) technique without the side effects observed with the CSE technique.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal Anesthesia | Active comparator | Drug: hyperbaric bupivacaine and fentanylPatients received 3-ml hyperbaric bupivacaine 0.5% and 25 mcg fentanyl (0.5-ml). |
| Dural Puncture Epidural Anesthesia | Experimental | Drug: plain bupivacaine and fentanylPatients received 15-ml mixture of bupivacaine 0.25% and 50 mcg fentanyl over 5 minutes , injected in the epidural space by epidural catheter at L3-L4 interspace, a dural puncture was created by the spinal needle. Braun's Espocan® combined spinal epidural kit before insertion of epidural catheter (needle-through-needle technique) but intrathecal medication administration was withheld. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years.
- Both sex.
- American Society of Anesthesiology (ASA) physical status I, II, III.
- Admitted for elective rigid cystoscopy.
Key exclusion criteria (6 listed)
- Refusal of patients.
- Body Mass Index (BMI) > 35.
- Patients who have history of substance abuse.
- Patients with difficult communication.
- Contraindication to neuraxial anesthesia (e.g.; infection near the site of injection, coagulopathy or bleeding disorder).
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 |
|---|---|---|
| hyperbaric bupivacaine and fentanylAlso: Spinal AnesthesiaPatients received 3ml hyperbaric bupivacaine 0.5% combined with 25 microg of fentanyl. | Drug | Spinal Anesthesia |
| plain bupivacaine and fentanylAlso: Dural Puncture Epidural AnesthesiaPatients received 15 mL mixture of (0.25% plain bupivacaine and 50 µg fentanyl) over 5 minutes, injected in the epidural space by epidural catheter at L3-L4 interspace, a dural puncture was created by the spinal needle. Braun's Espocan® combined spinal epidural kit before insertion of epidural catheter (needle-through-needle technique) but intrathecal medication administration was withheld. | Drug | Dural Puncture Epidural Anesthesia |
Primary outcome
Assessment of the onset of anesthesia
Time frame: Every 15 minutes till end of the surgery
Assessment of the onset by test sensory loss at T10 by pin prick using sterile needle with blunt edge (defined as time from end of injection of bolus dose to 1st sign of sensory block at T10). Sensory level of the techniques which was assessed at 2 min after end of injection of the drug then every 5 min till the 30 min then every 15 min till end of the surgery.
3 secondary outcomes
Time of onset of motor block
Time frame: Till the end of the surgery
Incidence of side effects
Time frame: 24 hours postoperatively
Number of patients required rescue analgesia
Time frame: 24 hours postoperatively
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 18 Jul 2024.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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 hyperbaric bupivacaine and fentanyl and plain bupivacaine and fentanyl in people with Dural Puncture Epidural Anesthesia and Spinal Anesthesia, run by Tanta 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 4 inclusion and 6 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 18 Jul 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?
Assessment of the onset of anesthesia (time frame: Every 15 minutes till end of the surgery). 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 18 Jul 2024.