Post Operative PainDexmed/tapNCT06624319
Two Doses of Dexmedetomidine as Adjuvent to Bupivacaine in Tap Block
A study testing Dexmedetomidine as adjuvent to bupvacaine in tap block in people with Post Operative Pain, run by Assiut University at 1 site in Egypt.
Trial summary
The aim of this study to determine the optimal dose of dexmedetomidine as an adjuvant to bupivacaine in U.S guided TAP block for preemptive analgesia In patients undergoing lower abdominal cancer surgeries. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Dexmedetomidine as adjuvent to bupvacaine in tap block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2025to Feb 2026
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age from 18 to 65 years old
- lower abdominal cancer surgery
Who cannot join
- patient refusal
- the local anesthetic allergy
- coagulopathy
- local infection at the procedure site
- psychic patients
- patient on chronic opioid use
Trial locations and contacts
1 site in 1 country.
Egypt1 site
South egypt cancer institute,Assiut University
Asyut
Kerolos S Tawfeek, Resident, 01551990411, Kerolossalama7@gmail.com
Mohanad A Mohamed, Lecturer, 01027068866, Mohanad.abosagheer@gmail.com
About this study
Official title: Comparing the Analgesic Effect of Two Different Doses of Dexmedetomidine Added to Bupivacaine in Ultrasound-guided Transversus Abdominis Plane Block in Patients Undergoing Lower Abdominal Cancer Surgeries; A Randomized Clinical Trial
The aim of this study to determine the optimal dose of dexmedetomidine as an adjuvant to bupivacaine in U.S guided TAP block for preemptive analgesia In patients undergoing lower abdominal cancer surgeries.
Read the detailed description
The transversus abdominis plane (TAP) involves innervations of the anterolateral abdominal wall derived from T6-L1. The block can be given either by anatomical landmark technique or by using an ultrasound probe. The local anesthetic is deposited in a plane between internal oblique and transversus abdominis muscle. It provides adequate postoperative analgesia following various abdominal surgeries.Dexmedetomidine is an alpha-2 agonist that has been approved as a venous sedative and an adjuvant for pain relief .In previous studies, the addition of dexmedetomidine to bupivacaine in the TAP block has prolonged the effect of this block . So far, the optimal dose of dexmedetomidine for the TAP block has not been determined.
- Conditions
- Post Operative Pain
- Being tested
- Dexmedetomidine as adjuvent to bupvacaine in tap block
- Keywords
- Tap block, Dexmedetomidine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine as adjuvent to bupvacaine in tap blockDrug
Also called Precedex
The analgesic effect of Two different doses of dexmedetomidine as adjuvent to bupivacaine in tap block
| Study group | Role | What they receive |
|---|---|---|
| tap block with 0.5 μg/kg dexmedetomidine | Active comparator | will receive pre-emptive ultrasound-guided tap block with 0.5 μg/kg dexmedetomidine in 20 ml volume added to 20 mL of 0.25% bupivacaine (40 ml in total) 20 ml will be applied on each side of the abdominal wall after induction of GA. Receives: Drug: Dexmedetomidine as adjuvent to bupvacaine in tap block |
| tap block with 1.5 μg/kg dexmedetomidine | Active comparator | will receive pre-emptive ultrasound-guided tap block with 1.5 μg/kg dexmedetomidine in 20 ml volume added to 20 mL of 0.25% bupivacaine (40 ml in total) 20 ml will be applied on each side of the abdominal wall after induction of GA. Receives: Drug: Dexmedetomidine as adjuvent to bupvacaine in tap block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine consumption during the first 24 hours postoperatively
Morphine consumption during the First 24 hours postoperative
Measured: First 24 hours postoperative
Secondary outcomes (2)
Severity of pain using Visual analogue scale
The severity of pain at rest and on coughing will be assesd using a 10-cm vas(0 means no pain ,10 means worst pain)
Measured: First 24 hours postoperative
Patient level of sedation using four point modified ramsy scale
using a 4-point scale (0 = awake and alert, 1 = minimally sedated, responds to speech, 2 = moderately sedated, arousable by tactile stimulation, and 3 = deeply sedated, arousable only by painful stimulation)
Measured: First 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study startJan 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will receive pre-emptive ultrasound-guided tap block with two different doses of dexmedetomidine in 20 ml volume added to 20 mL of 0.25% bupivacaine (40 ml in total) 20 ml will be applied on each side of the abdominal wall after induction of GA.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kerolos Salama Tawfeek, Assiut University
- Investigators
- Kerolos S Tawfeek, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06624319
- Sponsor's protocol ID
- 04-2024-200895
- Acronym
- Dexmed/tap
- Status last verified
- Oct 2024
- First submitted
- 28 Sep 2024
- Last updated
- 3 Oct 2024
- 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 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Analgesic Effect of Two Different Doses of Dexmedetomidine Added to Bupivacaine in Ultrasound-guided Transversus Abdominis Plane Block in Patients Undergoing Lower Abdominal Cancer Surgeries; A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06624319
- Acronym / sponsor ID
- Dexmed/tap / 04-2024-200895
- Conditions
- Post Operative Pain
- Keywords
- Tap block, Dexmedetomidine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 2 Oct 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 aim of this study to determine the optimal dose of dexmedetomidine as an adjuvant to bupivacaine in U.S guided TAP block for preemptive analgesia In patients undergoing lower abdominal cancer surgeries.
Detailed description
The transversus abdominis plane (TAP) involves innervations of the anterolateral abdominal wall derived from T6-L1. The block can be given either by anatomical landmark technique or by using an ultrasound probe. The local anesthetic is deposited in a plane between internal oblique and transversus abdominis muscle. It provides adequate postoperative analgesia following various abdominal surgeries.Dexmedetomidine is an alpha-2 agonist that has been approved as a venous sedative and an adjuvant for pain relief .In previous studies, the addition of dexmedetomidine to bupivacaine in the TAP block has prolonged the effect of this block . So far, the optimal dose of dexmedetomidine for the TAP block has not been determined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will receive pre-emptive ultrasound-guided tap block with two different doses of dexmedetomidine in 20 ml volume added to 20 mL of 0.25% bupivacaine (40 ml in total) 20 ml will be applied on each side of the abdominal wall after induction of GA.
| Arm | Type | Receives |
|---|---|---|
| tap block with 0.5 μg/kg dexmedetomidine | Active comparator | Drug: Dexmedetomidine as adjuvent to bupvacaine in tap blockwill receive pre-emptive ultrasound-guided tap block with 0.5 μg/kg dexmedetomidine in 20 ml volume added to 20 mL of 0.25% bupivacaine (40 ml in total) 20 ml will be applied on each side of the abdominal wall after induction of GA. |
| tap block with 1.5 μg/kg dexmedetomidine | Active comparator | Drug: Dexmedetomidine as adjuvent to bupvacaine in tap blockwill receive pre-emptive ultrasound-guided tap block with 1.5 μg/kg dexmedetomidine in 20 ml volume added to 20 mL of 0.25% bupivacaine (40 ml in total) 20 ml will be applied on each side of the abdominal wall after induction of GA. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age from 18 to 65 years old
- lower abdominal cancer surgery
Key exclusion criteria (6 listed)
- patient refusal
- the local anesthetic allergy
- coagulopathy
- local infection at the procedure site
- psychic patients
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 |
|---|---|---|
| Dexmedetomidine as adjuvent to bupvacaine in tap blockAlso: PrecedexThe analgesic effect of Two different doses of dexmedetomidine as adjuvent to bupivacaine in tap block | Drug | tap block with 0.5 μg/kg dexmedetomidine, tap block with 1.5 μg/kg dexmedetomidine |
Primary outcome
Total morphine consumption during the first 24 hours postoperatively
Time frame: First 24 hours postoperative
Morphine consumption during the First 24 hours postoperative
2 secondary outcomes
Severity of pain using Visual analogue scale
Time frame: First 24 hours postoperative
Patient level of sedation using four point modified ramsy scale
Time frame: First 24 hours postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
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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.
Kerolos S Tawfeek principal investigator
Assiut 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 Dexmedetomidine as adjuvent to bupvacaine in tap block in people with Post Operative Pain, run by Assiut 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 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: status not confirmed, as of the sponsor's last update on 3 Oct 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kerolos S Tawfeek, Resident (+2001551990411, Kerolossalama7@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total morphine consumption during the first 24 hours postoperatively (time frame: First 24 hours postoperative). 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 3 Oct 2024.