DexmedetomidinePhase 2/3NCT04971759
Dexmedetomidine to Levobupivacaine for Transversus Abdominis Plane Block in Elderly Patients Undergoing Inguinal Hernia Repair Surgery
A Phase 2/3 study testing Levobupivacaine, Dexmedetomidine Hydrochloride and Fentanyl in people with Dexmedetomidine and Fentanyl, run by Assiut University at 1 site in Egypt.
Trial summary
The perioperative management of pain following abdominal surgery can pose a challenge to anesthesia providers. Conventional practice has involved the use of opioids as well as neuraxial analgesic techniques. Unfortunately, these therapies are not without potential risks and side effects. Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Dexmedetomidine, Fentanyl
- What is being tested?
- Levobupivacaine, Dexmedetomidine Hydrochloride and Fentanyl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2019to 1 Feb 2021
- Phase
- Phase 2/3
- 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 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA status I, II, and III patients,
- aged 60-75 y,
- both male and female,
- undergoing inguinal hernia repair surgery.
Who cannot join
- morbid obesity (BMI > 40),
- spine metastatic tumor, allergy to an amide LA, or magnesium sulfate,
- heart block, renal, or liver dysfunction, substance abuse disorder, chronic opioid use, or electrolyte disturbance, administration of any sedative, preexisting mental illness, psychological or emotional problems.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Addition of Dexmedetomidine to Levobupivacaine for Transversus Abdominis Plane Block in Elderly Patients Undergoing Inguinal Hernia Repair Surgery: Could it Make a Difference?
The perioperative management of pain following abdominal surgery can pose a challenge to anesthesia providers. Conventional practice has involved the use of opioids as well as neuraxial analgesic techniques. Unfortunately, these therapies are not without potential risks and side effects. These include nausea, vomiting, pruritus, urinary retention, constipation, respiratory depression, and sedation.
Read the detailed description
As a result, the goal to reduce perioperative pain has taken on a multimodal approach.
Multimodal or "balanced" analgesia uses a combination of opioid and nonopioid analgesics to improve pain control and minimize opioid-related side effects. These include the use of nonsteroidal anti-inflammatory drugs, local anesthetics, peripheral nerve blocks, gabapentinoids, and alpha2 adrenergic agonists. Any combination of these therapies can help reduce the surgical stress response and improve patient outcomes such as pain control, patient satisfaction, time to discharge, and return to daily activities.
One method used in this multimodal approach is the transversus abdominis plane block. As first described by Rafi in 2001, this block provides analgesia to the anterolateral abdominal wall. In 2007, further studied this technique in patients undergoing large-bowel resection. He discovered a reduction in postoperative pain and morphine consumption in the first 24 hours postoperatively, resulting in fewer opioid-mediated side effects. In this same year, Hebbard described the use of ultrasound guidance to provide real-time imaging of the muscle layers and needle placement to improve TAP block accuracy. In 2008, Hebbard. described the subcostal approach of TAP blocks, to target the nerves of the upper abdomen. Transversus abdominis plane blocks continue to be studied and developed as an effective method for providing analgesia for numerous types of abdominal surgeries.
- Conditions
- Dexmedetomidine, Fentanyl
- Being tested
- Levobupivacaine, Dexmedetomidine Hydrochloride, Fentanyl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevobupivacaineDrug
Levobupivacaine 5%
Dexmedetomidine HydrochlorideDrug
Levobupivacaine 5% + 1 µg/kg dexmedetomidine.
FentanylDrug
Levobupivacaine 5% + 1µg/kg fentanyl
| Study group | Role | What they receive |
|---|---|---|
| Group L | Experimental | 30 Patients will receive Levobupivacaine 5% Receives: Drug: Levobupivacaine |
| LD group | Experimental | 30 patients will receive Levobupivacaine 5% + 1 µg/kg dexmedetomidine. Receives: Drug: Dexmedetomidine Hydrochloride |
| LF group | Experimental | 30 patients will receive Levobupivacaine 5% + 1µg/kg fentanyl Receives: Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
first analgesic request
time for the first analgesia rescue call.
Measured: 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 posted21 Jul 2021
- Study start1 Dec 2019
- Primary completion30 Dec 2020
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DexmedetomidineStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada Mohammed AboelFadl, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04971759
- Sponsor's protocol ID
- 17300618
- Status last verified
- Jul 2021
- First submitted
- 6 Jul 2021
- Last updated
- 21 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Milone M, Di Minno MN, Musella M, Maietta P, Salvatore G, Iacovazzo C, Milone F. Outpatient inguinal hernia repair under local anaesthesia: feasibility and efficacy of ultrasound-guided transversus abdominis plane block. Hernia. 2013 Dec;17(6):749-55. doi: 10.1007/s10029-012-1022-2. Epub 2012 Nov 16.
PubMed 23160979Favuzza J, Brady K, Delaney CP. Transversus abdominis plane blocks and enhanced recovery pathways: making the 23-h hospital stay a realistic goal after laparoscopic colorectal surgery. Surg Endosc. 2013 Jul;27(7):2481-6. doi: 10.1007/s00464-012-2761-y. Epub 2013 Jan 26.
PubMed 23355160Walter CJ, Maxwell-Armstrong C, Pinkney TD, Conaghan PJ, Bedforth N, Gornall CB, Acheson AG. A randomised controlled trial of the efficacy of ultrasound-guided transversus abdominis plane (TAP) block in laparoscopic colorectal surgery. Surg Endosc. 2013 Jul;27(7):2366-72. doi: 10.1007/s00464-013-2791-0. Epub 2013 Feb 7.
PubMed 23389068Abo Elfadl GM, Ali WN, Ahmed FN, Abd El-Rady NM, Ali AM, Abdel Rady MM. Add dexmedetomidine to levobupivacaine for transversus abdominis plane block in elderly patients undergoing inguinal hernia repair: Could it make a difference? A randomised trial. J Perioper Pract. 2024 Nov;34(11):339-346. doi: 10.1177/17504589231196653. Epub 2023 Oct 9.
PubMed 37811840
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addition of Dexmedetomidine to Levobupivacaine for Transversus Abdominis Plane Block in Elderly Patients Undergoing Inguinal Hernia Repair Surgery: Could it Make a Difference?
- ClinicalTrials.gov ID
- NCT04971759
- Acronym / sponsor ID
- 17300618
- Conditions
- Dexmedetomidine, Fentanyl
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 21 Jul 2021 (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 perioperative management of pain following abdominal surgery can pose a challenge to anesthesia providers. Conventional practice has involved the use of opioids as well as neuraxial analgesic techniques. Unfortunately, these therapies are not without potential risks and side effects. These include nausea, vomiting, pruritus, urinary retention, constipation, respiratory depression, and sedation.
Detailed description
As a result, the goal to reduce perioperative pain has taken on a multimodal approach.
Multimodal or "balanced" analgesia uses a combination of opioid and nonopioid analgesics to improve pain control and minimize opioid-related side effects. These include the use of nonsteroidal anti-inflammatory drugs, local anesthetics, peripheral nerve blocks, gabapentinoids, and alpha2 adrenergic agonists. Any combination of these therapies can help reduce the surgical stress response and improve patient outcomes such as pain control, patient satisfaction, time to discharge, and return to daily activities.
One method used in this multimodal approach is the transversus abdominis plane block. As first described by Rafi in 2001, this block provides analgesia to the anterolateral abdominal wall. In 2007, further studied this technique in patients undergoing large-bowel resection. He discovered a reduction in postoperative pain and morphine consumption in the first 24 hours postoperatively, resulting in fewer opioid-mediated side effects. In this same year, Hebbard described the use of ultrasound guidance to provide real-time imaging of the muscle layers and needle placement to improve TAP block accuracy. In 2008, Hebbard. described the subcostal approach of TAP blocks, to target the nerves of the upper abdomen. Transversus abdominis plane blocks continue to be studied and developed as an effective method for providing analgesia for numerous types of 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 L | Experimental | Drug: Levobupivacaine30 Patients will receive Levobupivacaine 5% |
| LD group | Experimental | Drug: Dexmedetomidine Hydrochloride30 patients will receive Levobupivacaine 5% + 1 µg/kg dexmedetomidine. |
| LF group | Experimental | Drug: Fentanyl30 patients will receive Levobupivacaine 5% + 1µg/kg fentanyl |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA status I, II, and III patients,
- aged 60-75 y,
- both male and female,
- undergoing inguinal hernia repair surgery.
Key exclusion criteria (3 listed)
- morbid obesity (BMI > 40),
- spine metastatic tumor, allergy to an amide LA, or magnesium sulfate,
- heart block, renal, or liver dysfunction, substance abuse disorder, chronic opioid use, or electrolyte disturbance, administration of any sedative, preexisting mental illness, psychological or emotional problems.
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 |
|---|---|---|
| LevobupivacaineLevobupivacaine 5% | Drug | Group L |
| Dexmedetomidine HydrochlorideLevobupivacaine 5% + 1 µg/kg dexmedetomidine. | Drug | LD group |
| FentanylLevobupivacaine 5% + 1µg/kg fentanyl | Drug | LF group |
Primary outcome
first analgesic request
Time frame: 24 hours postoperative
time for the first analgesia rescue call.
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 21 Jul 2021.
- Results publication: PubMed 23160979Milone M, Di Minno MN, Musella M, Maietta P, Salvatore G, Iacovazzo C, Milone F. Outpatient inguinal hernia repair under local anaesthesia: feasibility and efficacy of ultrasound-guided transversus abdominis plane block. Hernia. 2013 Dec;17(6):749-55. doi: 10.1007/s10029-012-1022-2. Epub 2012 Nov 16.
- Results publication: PubMed 23355160Favuzza J, Brady K, Delaney CP. Transversus abdominis plane blocks and enhanced recovery pathways: making the 23-h hospital stay a realistic goal after laparoscopic colorectal surgery. Surg Endosc. 2013 Jul;27(7):2481-6. doi: 10.1007/s00464-012-2761-y. Epub 2013 Jan 26.
- Results publication: PubMed 23389068Walter CJ, Maxwell-Armstrong C, Pinkney TD, Conaghan PJ, Bedforth N, Gornall CB, Acheson AG. A randomised controlled trial of the efficacy of ultrasound-guided transversus abdominis plane (TAP) block in laparoscopic colorectal surgery. Surg Endosc. 2013 Jul;27(7):2366-72. doi: 10.1007/s00464-013-2791-0. Epub 2013 Feb 7.
- Derived from this study: PubMed 37811840Abo Elfadl GM, Ali WN, Ahmed FN, Abd El-Rady NM, Ali AM, Abdel Rady MM. Add dexmedetomidine to levobupivacaine for transversus abdominis plane block in elderly patients undergoing inguinal hernia repair: Could it make a difference? A randomised trial. J Perioper Pract. 2024 Nov;34(11):339-346. doi: 10.1177/17504589231196653. Epub 2023 Oct 9.
- Individual participant dataSharing planned: Undecided
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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 Phase 2/3 study testing Levobupivacaine, Dexmedetomidine Hydrochloride and Fentanyl in people with Dexmedetomidine and Fentanyl, 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 4 inclusion and 3 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 21 Jul 2021. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
first analgesic request (time frame: 24 hours postoperative). 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 NCT04971759, which also lists 4 linked publications.
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 21 Jul 2021.