PainNCT04318158
Dexmedetomidine Versus Fentanyl as Adjuvants to Bupivacaine in Ultrasound Guided Transversus Abdominis Plane Block
A study testing Bupivacaine, Dexmedetomidine and Fentanyl in people with Pain, run by Beni-Suef University.
Trial summary
The aim and objective of this study is to compare dexmedetomidine and fentanyl as adjuvants to bupivacaine in ultrasound guided TAP block analgesia in patients undergoing radical cystectomy as regarding postoperative analgesic efficacy. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Pain
- What is being tested?
- Bupivacaine, Dexmedetomidine and Fentanyl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Apr 2020to May 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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both sexes.
- ASA grade I and II.
- Age between 50-70 years.
- Elective open radical cystectomy.
Who cannot join
- Any history or signs of cardiac, hepatic and renal failure.
- Patients with coagulopathy or under anticoagulation therapy.
- Infection near the site of needle insertion.
- Morbid obesity (BMI>40 kg/m2).
- History of allergic reactions to any of the study medications.
- Previous abdominal surgery.
- Patients with any neurological or neuromuscular disorder or history of seizures.
About this study
Official title: A Comparative Study of Dexmedetomidine Versus Fentanyl as Adjuvants to Bupivacaine in Ultrasound Guided Transversus Abdominis Plane Block in Patients Undergoing Radical Cystectomy
The aim and objective of this study is to compare dexmedetomidine and fentanyl as adjuvants to bupivacaine in ultrasound guided TAP block analgesia in patients undergoing radical cystectomy as regarding postoperative analgesic efficacy.
Read the detailed description
Radical cystectomy with pelvic lymph node dissection is the gold standard treatment for muscle invasive bladder cancer and is associated with a high risk of complications. Management of the postoperative pain is important to decrease the length of stay in the hospital and the risk of morbidity. Multimodal analgesia management is utilized for pain observed in the postoperative period.As part of a multimodal analgesic regimen, a peripheral nerve block can decrease opioid consumption, providing more effective analgesia with fewer adverse effects.TAP block is a relatively new regional anesthesia technique that provides analgesia to the parietal peritoneum, as well as skin and muscles of the lower anterior abdominal wall. Dexmedetomidine and fentanyl have been used as adjuvants to local anesthetics in different surgeries to provide superior analgesia and to improve the duration of the block.
- Conditions
- Pain
- Being tested
- Bupivacaine, Dexmedetomidine, Fentanyl
- Keywords
- Dexmedetomidine, Fentanyl, Bupivacaine, Transversus Abdominis Plane Block
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Also called Sunnypivacaine
single shot US guided TAP block using 20 ml bupivacaine 0.25%.
DexmedetomidineDrug
Also called Precedex
Single shot US guided TAP block using 20 ml bupivacaine 0.25% + 50 µg dexmedetomedine on each side.
FentanylDrug
Also called Fentanyl hameln
Single shot US guided TAP block using 20 ml bupivacaine 0.25% + 50 µg fentanyl on each side.
| Study group | Role | What they receive |
|---|---|---|
| Group(B) | Experimental | Patients will receive single shot US guided TAP block using 20 ml bupivacaine 0.25% on each side. Receives: Drug: Bupivacaine |
| Group(BD) | Active comparator | Patients will receive single shot US guided TAP block using 20 ml bupivacaine 0.25% + 50 µg dexmedetomedine on each side. Receives: Drug: Dexmedetomidine |
| Group(BF) | Active comparator | Patients will receive single shot US guided TAP block using 20 ml bupivacaine 0.25% + 50 µg fentanyl on each side. Receives: Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time for first rescue analgesia after the TAP block.
Postoperative analgesia duration.
Measured: first 24 hours after block.
Secondary outcomes (2)
the total dose of rescue analgesia after TAP bock.
Postoperative analgesia consumption.
Measured: first 24 hours after block.
VAS for pain.
Postoperative pain at rest and movement.
Measured: 0, 2, 4, 6, 12 and 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 posted23 Mar 2020
- Study startApr 2020 (estimated)
- Primary completionApr 2021 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Beni-Suef 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Mahmoud Fakhry, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04318158
- Sponsor's protocol ID
- FMBSUREC/08032020/Fakhry
- Status last verified
- Mar 2020
- First submitted
- 19 Mar 2020
- Last updated
- 23 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kassim DY, Mahmoud HE, Fakhry DM, Mansour MA. Comparative study of dexmedetomidine versus fentanyl as adjuvants to bupivacaine in ultrasound-guided transversus abdominis plane block in patients undergoing radical cystectomy: a prospective randomised study. BMC Anesthesiol. 2022 Nov 7;22(1):340. doi: 10.1186/s12871-022-01877-1.
PubMed 36344917
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Dexmedetomidine Versus Fentanyl as Adjuvants to Bupivacaine in Ultrasound Guided Transversus Abdominis Plane Block in Patients Undergoing Radical Cystectomy
- ClinicalTrials.gov ID
- NCT04318158
- Acronym / sponsor ID
- FMBSUREC/08032020/Fakhry
- Conditions
- Pain
- Keywords
- Dexmedetomidine, Fentanyl, Bupivacaine, Transversus Abdominis Plane Block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- Apr 2020 (estimated)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 23 Mar 2020 (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 and objective of this study is to compare dexmedetomidine and fentanyl as adjuvants to bupivacaine in ultrasound guided TAP block analgesia in patients undergoing radical cystectomy as regarding postoperative analgesic efficacy.
Detailed description
Radical cystectomy with pelvic lymph node dissection is the gold standard treatment for muscle invasive bladder cancer and is associated with a high risk of complications. Management of the postoperative pain is important to decrease the length of stay in the hospital and the risk of morbidity. Multimodal analgesia management is utilized for pain observed in the postoperative period.As part of a multimodal analgesic regimen, a peripheral nerve block can decrease opioid consumption, providing more effective analgesia with fewer adverse effects.TAP block is a relatively new regional anesthesia technique that provides analgesia to the parietal peritoneum, as well as skin and muscles of the lower anterior abdominal wall. Dexmedetomidine and fentanyl have been used as adjuvants to local anesthetics in different surgeries to provide superior analgesia and to improve the duration of the block.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group(B) | Experimental | Drug: BupivacainePatients will receive single shot US guided TAP block using 20 ml bupivacaine 0.25% on each side. |
| Group(BD) | Active comparator | Drug: DexmedetomidinePatients will receive single shot US guided TAP block using 20 ml bupivacaine 0.25% + 50 µg dexmedetomedine on each side. |
| Group(BF) | Active comparator | Drug: FentanylPatients will receive single shot US guided TAP block using 20 ml bupivacaine 0.25% + 50 µg fentanyl on each side. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Both sexes.
- ASA grade I and II.
- Age between 50-70 years.
- Elective open radical cystectomy.
Key exclusion criteria (7 listed)
- Any history or signs of cardiac, hepatic and renal failure.
- Patients with coagulopathy or under anticoagulation therapy.
- Infection near the site of needle insertion.
- Morbid obesity (BMI>40 kg/m2).
- History of allergic reactions to any of the study medications.
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 |
|---|---|---|
| BupivacaineAlso: Sunnypivacainesingle shot US guided TAP block using 20 ml bupivacaine 0.25%. | Drug | Group(B) |
| DexmedetomidineAlso: PrecedexSingle shot US guided TAP block using 20 ml bupivacaine 0.25% + 50 µg dexmedetomedine on each side. | Drug | Group(BD) |
| FentanylAlso: Fentanyl hamelnSingle shot US guided TAP block using 20 ml bupivacaine 0.25% + 50 µg fentanyl on each side. | Drug | Group(BF) |
Primary outcome
The time for first rescue analgesia after the TAP block.
Time frame: first 24 hours after block.
Postoperative analgesia duration.
2 secondary outcomes
the total dose of rescue analgesia after TAP bock.
Time frame: first 24 hours after block.
VAS for pain.
Time frame: 0, 2, 4, 6, 12 and 24 hours postoperatively.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2020.
- Derived from this study: PubMed 36344917Kassim DY, Mahmoud HE, Fakhry DM, Mansour MA. Comparative study of dexmedetomidine versus fentanyl as adjuvants to bupivacaine in ultrasound-guided transversus abdominis plane block in patients undergoing radical cystectomy: a prospective randomised study. BMC Anesthesiol. 2022 Nov 7;22(1):340. doi: 10.1186/s12871-022-01877-1.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine, Dexmedetomidine and Fentanyl in people with Pain, run by Beni-Suef University.
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 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 23 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
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 time for first rescue analgesia after the TAP block. (time frame: first 24 hours after block.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04318158, which also lists 1 linked publication.
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 23 Mar 2020.