Regional Anesthesia MorbiditysaddleNCT06216197
Dexmedetomidine Versus Fentanyl as an Adjuvant to Bupivacaine in Saddle Block
A study testing FENT group and DEX group in people with Regional Anesthesia Morbidity, run by Zulekha Hospitals at 1 site in Egypt.
Trial summary
Dexmedetomidine is recommended over fentanyl as adjunctive medication to bupivacaine for saddle block spinal anesthesia in anal surgeries and procedures. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Regional Anesthesia Morbidity
- What is being tested?
- FENT group and DEX group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Apr 2021to 4 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- both sexes
- aged between 20 and 60
- classified as II \& ASA-I
- scheduled for elective anal surgeries
Who cannot join
- subjects who refused to participate
- uncontrolled hypertension
- BMI > 30 kg/m2
- heart failure (class IV or III) based on the New York Heart Association (NYHA)
- uncorrected coagulopathy
- any study's drug allergy
Show all 9Show fewer
- drug abuse
- neuropathy
- any spinal anesthesia contraindication (such as infection or a pelvic fracture)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dexmedetomidine Versus Fentanyl as an Adjuvant to Bupivacaine in Saddle Block for Various Anal Surgeries: A Correlative Randomized Trial
Dexmedetomidine is recommended over fentanyl as adjunctive medication to bupivacaine for saddle block spinal anesthesia in anal surgeries and procedures.
Read the detailed description
Objectives: A saddle spinal block is a viable choice for anal surgeries. This technique effectively maintains balanced hemodynamics, and fast recovery, and prevents irrelevant motor blocks in both limbs.
Methods: Fifty-eight adult patients were categorized into two groups. Group FENT, consisting of 29 patients, underwent a saddle block with hyperbaric bupivacaine (2.5 ml) combined with fentanyl (0.5 ml; 25 μg). The DEX Group, consisting of 29 patients, received 2.5 ml of hyperbaric bupivacaine mixed with dexmedetomidine (10 μg; 0.5 ml). Continuous monitoring of HR and SpO2 was conducted. Evaluation of sensory blockage and the motor block was done utilizing the Bromage scale. Following surgery, assessments were conducted. Pain in the ward and PACU was determined utilizing the visual analog scale (VAS).
- Conditions
- Regional Anesthesia Morbidity
- Being tested
- FENT group, DEX group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FENT groupDrug
Also called fentanyl group
Group FENT, consisting of 29 patients, underwent a saddle block with hyperbaric bupivacaine (2.5 ml) combined with fentanyl (0.5 ml; 25 μg).
DEX groupDrug
Also called dexmedetomidine group
The DEX Group, consisting of 29 patients, received 2.5 ml of hyperbaric bupivacaine mixed with dexmedetomidine (10 μg; 0.5 ml).
| Study group | Role | What they receive |
|---|---|---|
| The FENT Group | Other | Group FENT, consisting of 29 patients, underwent a saddle block with hyperbaric bupivacaine (2.5 ml) combined with fentanyl (0.5 ml; 25 μg). Receives: Drug: FENT group |
| The DEX Group | Other | The DEX Group, consisting of 29 patients, received 2.5 ml of hyperbaric bupivacaine mixed with dexmedetomidine (10 μg; 0.5 ml). Receives: Drug: DEX group |
What is being measured
The primary outcome is the main question the study is designed to answer.
the duration until the first call for analgesia
the duration until the first call for analgesia
Measured: 20 months
Secondary outcomes (5)
the duration from spinal injection until reaching the maximal sensory level
the duration from spinal injection until reaching the maximal sensory level
Measured: 20 months
the duration needed for sensory regression to occur over two spinal segments from the maximal sensory level
the duration needed for sensory regression to occur over two spinal segments from the maximal sensory level
Measured: 20 months
the time required for sensory regression until reaching the S1 level (from the maximal sensory level)
the time required for sensory regression until reaching the S1 level (from the maximal sensory level)
Measured: 20 months
the duration from injection to achieving Bromage 0, the total tramadol consumption (until the first 24 hours)
the duration from injection to achieving Bromage 0, the total tramadol consumption (until the first 24 hours)
Measured: 20 months
side effects occurrences
side effects occurrences
Measured: 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start3 Apr 2021
- Primary completion4 Dec 2022
- Study completion4 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Regional Anesthesia MorbidityStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Fifty-eight adult patients were categorized into two groups. Group FENT, consisting of 29 patients, underwent a saddle block with hyperbaric bupivacaine (2.5 ml) combined with fentanyl (0.5 ml; 25 μg). The DEX Group, consisting of 29 patients, received 2.5 ml of hyperbaric bupivacaine mixed with dexmedetomidine (10 μg; 0.5 ml).
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zulekha Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- sameh ha seyam, MD, Study chair, assistant professor of anesthesiology, intensive care and pain management
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06216197
- Sponsor's protocol ID
- 0395/2023
- Acronym
- saddle
- Status last verified
- Jan 2024
- First submitted
- 26 Dec 2023
- Last updated
- 22 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: available
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine Versus Fentanyl as an Adjuvant to Bupivacaine in Saddle Block for Various Anal Surgeries: A Correlative Randomized Trial
- ClinicalTrials.gov ID
- NCT06216197
- Acronym / sponsor ID
- saddle / 0395/2023
- Conditions
- Regional Anesthesia Morbidity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Zulekha HospitalsUniversity, hospital or other
- Study start
- 3 Apr 2021 (actual)
- Primary completion
- 4 Dec 2022 (actual)
- Study completion
- 4 Dec 2022 (actual)
- First posted
- 22 Jan 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.
Dexmedetomidine is recommended over fentanyl as adjunctive medication to bupivacaine for saddle block spinal anesthesia in anal surgeries and procedures.
Detailed description
Objectives: A saddle spinal block is a viable choice for anal surgeries. This technique effectively maintains balanced hemodynamics, and fast recovery, and prevents irrelevant motor blocks in both limbs.
Methods: Fifty-eight adult patients were categorized into two groups. Group FENT, consisting of 29 patients, underwent a saddle block with hyperbaric bupivacaine (2.5 ml) combined with fentanyl (0.5 ml; 25 μg). The DEX Group, consisting of 29 patients, received 2.5 ml of hyperbaric bupivacaine mixed with dexmedetomidine (10 μg; 0.5 ml). Continuous monitoring of HR and SpO2 was conducted. Evaluation of sensory blockage and the motor block was done utilizing the Bromage scale. Following surgery, assessments were conducted. Pain in the ward and PACU was determined utilizing the visual analog scale (VAS).
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Fifty-eight adult patients were categorized into two groups. Group FENT, consisting of 29 patients, underwent a saddle block with hyperbaric bupivacaine (2.5 ml) combined with fentanyl (0.5 ml; 25 μg). The DEX Group, consisting of 29 patients, received 2.5 ml of hyperbaric bupivacaine mixed with dexmedetomidine (10 μg; 0.5 ml).
| Arm | Type | Receives |
|---|---|---|
| The FENT Group | Other | Drug: FENT groupGroup FENT, consisting of 29 patients, underwent a saddle block with hyperbaric bupivacaine (2.5 ml) combined with fentanyl (0.5 ml; 25 μg). |
| The DEX Group | Other | Drug: DEX groupThe DEX Group, consisting of 29 patients, received 2.5 ml of hyperbaric bupivacaine mixed with dexmedetomidine (10 μg; 0.5 ml). |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- both sexes
- aged between 20 and 60
- classified as II \& ASA-I
- scheduled for elective anal surgeries
Key exclusion criteria (9 listed)
- subjects who refused to participate
- uncontrolled hypertension
- BMI > 30 kg/m2
- heart failure (class IV or III) based on the New York Heart Association (NYHA)
- uncorrected coagulopathy
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 |
|---|---|---|
| FENT groupAlso: fentanyl groupGroup FENT, consisting of 29 patients, underwent a saddle block with hyperbaric bupivacaine (2.5 ml) combined with fentanyl (0.5 ml; 25 μg). | Drug | The FENT Group |
| DEX groupAlso: dexmedetomidine groupThe DEX Group, consisting of 29 patients, received 2.5 ml of hyperbaric bupivacaine mixed with dexmedetomidine (10 μg; 0.5 ml). | Drug | The DEX Group |
Primary outcome
the duration until the first call for analgesia
Time frame: 20 months
the duration until the first call for analgesia
5 secondary outcomes
the duration from spinal injection until reaching the maximal sensory level
Time frame: 20 months
the duration needed for sensory regression to occur over two spinal segments from the maximal sensory level
Time frame: 20 months
the time required for sensory regression until reaching the S1 level (from the maximal sensory level)
Time frame: 20 months
the duration from injection to achieving Bromage 0, the total tramadol consumption (until the first 24 hours)
Time frame: 20 months
side effects occurrences
Time frame: 20 months
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 22 Jan 2024.
- Individual participant dataSharing planned: No. available
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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.
sameh ha seyam, MD study chair
assistant professor of anesthesiology, intensive care and pain management
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FENT group and DEX group in people with Regional Anesthesia Morbidity, run by Zulekha Hospitals 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 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: finished, as of the sponsor's last update on 22 Jan 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?
the duration until the first call for analgesia (time frame: 20 months). 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 22 Jan 2024.