AnesthesiaPhase 4NCT05323565
Dexmedetomine vs Dexamethasone in TAB Block for Abdominal Surgries
A Phase 4 study testing Dexmedetomidine in people with Anesthesia, run by Ain Shams University at 1 site in Egypt.
Trial summary
Randomized controlled clinical Trial to compare the efficacy and duration of postoperative analgesia achieved after adding dexmedetomidine or dexamethasone to bupivacaine in TAP block for lower open abdominal surgeries. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Dexmedetomidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2022to 5 Jul 2022
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Adult patients, Age 20-60 years. Elective operation under general anesthesia. Physical Status: ASA I and II Patients. Body mass index 25-35 kg/m2.
Who cannot join
- Infection at site of injection.
- Patient refusal.
- Psychiatric or physical illness that lead to inability to cooperate, speak or read.
- Abdominal operations under spinal anesthesia.
- History or evidence of coagulopathy.
- Known allergies to drugs used .
- Preexisting neurological disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study Between the Use of Dexmedetomidine Versus Dexamethasone as Adjuvant to Bupivacaine in Ultrasound-guided Transversus Abdominis Plane Block for Post-operative Pain Relief in Patients Undergoing Lower Open Abdominal Surgeries
Randomized controlled clinical Trial to compare the efficacy and duration of postoperative analgesia achieved after adding dexmedetomidine or dexamethasone to bupivacaine in TAP block for lower open abdominal surgeries.
Read the detailed description
A Comparative study between the use of dexmedetomidine versus dexamethasone as adjuvant to bupivacaine in ultrasound-guided transversus abdominis plane block for post-operative pain relief in patients undergoing lower open abdominal surgeries
- Conditions
- Anesthesia
- Being tested
- Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called dexamethasone
adjuvants to 0.25 bupivacaine in TAB block.
| Study group | Role | What they receive |
|---|---|---|
| Group A (n=15): (Dexamethasone group) | Active comparator | Patients will receive 20 ml 0.25% bupivacaine plus 4 mg dexamethasone on each side TAB bock. Receives: Drug: Dexmedetomidine |
| Group B (n=15): (Dexmedetomidine group) | Active comparator | Patients will receive 20 ml 0.25% bupivacaine plus 0.5 mcg/kg of dexmedetomidine on each side TAB block. Receives: Drug: Dexmedetomidine |
| Group C (n=15): (control group) | Sham comparator | Patients will receive 20 ml 0.25% bupivacaine on each side TAB block. Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
1st time for rescue analgesia
Time to first analgesia requirment(starting from drug injection)
Measured: first 24 hours post-operatively
Secondary outcomes (1)
Pain score- Visual Analogue Score (VAS)
It ranges from 0 indicating no pain till 10 indicating severe intolerable pain with variable degrees of ascending pain in between] was assessed at 0 min (AT PACU), 2hr,6 hr, 12 hr, 18 hr, and 24 hr postoperatively.
Measured: First 24 hours post-operatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start1 Apr 2022
- Primary completion1 Jul 2022 (estimated)
- Study completion5 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasser Sayed Sobhy, Ain Shams University
- Investigators
- Yasser Sayed, Master, Principal investigator, Ain Shams University, Faculty of medecine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05323565
- Sponsor's protocol ID
- FMASU M D 184/2020
- Status last verified
- Apr 2022
- First submitted
- 5 Apr 2022
- Last updated
- 12 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between the Use of Dexmedetomidine Versus Dexamethasone as Adjuvant to Bupivacaine in Ultrasound-guided Transversus Abdominis Plane Block for Post-operative Pain Relief in Patients Undergoing Lower Open Abdominal Surgeries
- ClinicalTrials.gov ID
- NCT05323565
- Acronym / sponsor ID
- FMASU M D 184/2020
- Conditions
- Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 5 Jul 2022 (estimated)
- First posted
- 12 Apr 2022 (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.
Randomized controlled clinical Trial to compare the efficacy and duration of postoperative analgesia achieved after adding dexmedetomidine or dexamethasone to bupivacaine in TAP block for lower open abdominal surgeries.
Detailed description
A Comparative study between the use of dexmedetomidine versus dexamethasone as adjuvant to bupivacaine in ultrasound-guided transversus abdominis plane block for post-operative pain relief in patients undergoing lower open abdominal surgeries
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A (n=15): (Dexamethasone group) | Active comparator | Drug: DexmedetomidinePatients will receive 20 ml 0.25% bupivacaine plus 4 mg dexamethasone on each side TAB bock. |
| Group B (n=15): (Dexmedetomidine group) | Active comparator | Drug: DexmedetomidinePatients will receive 20 ml 0.25% bupivacaine plus 0.5 mcg/kg of dexmedetomidine on each side TAB block. |
| Group C (n=15): (control group) | Sham comparator | Drug: DexmedetomidinePatients will receive 20 ml 0.25% bupivacaine on each side TAB block. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Adult patients, Age 20-60 years. Elective operation under general anesthesia. Physical Status: ASA I and II Patients. Body mass index 25-35 kg/m2.
Key exclusion criteria (7 listed)
- Infection at site of injection.
- Patient refusal.
- Psychiatric or physical illness that lead to inability to cooperate, speak or read.
- Abdominal operations under spinal anesthesia.
- History or evidence of 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 |
|---|---|---|
| DexmedetomidineAlso: dexamethasoneadjuvants to 0.25 bupivacaine in TAB block. | Drug | Group A (n=15): (Dexamethasone group), Group B (n=15): (Dexmedetomidine group), Group C (n=15): (control group) |
Primary outcome
1st time for rescue analgesia
Time frame: first 24 hours post-operatively
Time to first analgesia requirment(starting from drug injection)
1 secondary outcome
Pain score- Visual Analogue Score (VAS)
Time frame: First 24 hours post-operatively.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
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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.
Yasser Sayed, Master principal investigator
Ain Shams University, Faculty of medecine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine in people with Anesthesia, run by Ain Shams 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 1 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 12 Apr 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
1st time for rescue analgesia (time frame: first 24 hours post-operatively). 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 12 Apr 2022; AzTrials last refreshed its copy on 6 Nov 2026.