- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03778671
Dexmedetomidine Versus Fentanyl Added to Levobupivacaine for Transversus Abdominis Plane (TAP) Block
October 8, 2021 updated by: Ghada Mohammed AboelFadl, Assiut University
Dexmedetomidine Versus Fentanyl Added to Levobupivacaine for Transversus Abdominis Plane (TAP) Block in Elderly Patients Undergoing Lower Abdominal Surgery
The perioperative management of pain following lower 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
One method used in this multimodal approach is the transversus abdominis plane block.
This block, as first described by Rafi. in 2001, provides analgesia to the anterolateral abdominal wall.
In 2007, McDonnell et al. 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 et al. described the use of ultrasound guidance to provide real-time imaging of the muscle layers and needle placement to improve transversus abdominis plane block accuracy.
In 2008, Hebbard.
described the subcostal approach of transversus abdominis plane block, 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 transverses abdominis plane block duration is limited to effect of administered local anesthetics.The use of an infusion catheter to administer local anesthetics is an option to prolong the block's duration.
Recently, adjuvant medications were added to local anesthetics to prolong the effect of transverses abdominis plane block .
Study Type
Interventional
Enrollment (Actual)
90
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Assiut, Egypt
- Assiut governorate
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 75 years (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- ASA physical status II-III,
- scheduled for uncomplicated elective paraumbilical hernia repair.
Exclusion Criteria:
- Patient refusal to participate in the study
- Patients with coagulopathy or under anticoagulation therapy.
- Infection near the site of needle insertion.
- Body mass index > 40kg/m2
- Patients with any neurological or neuromuscular disorder or history of seizures.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group B
Patients will receive Levobupivacaine 5%
|
Patients will receive Levobupivacaine 5%
Other Names:
|
Active Comparator: Group D
Patients will receive Levobupivacaine 5% + 1 µg/kg dexmedetomedine .
|
Patients will receive Levobupivacaine 5% + 1 µg/kg dexmedetomedine
|
Active Comparator: Group F
Patients will receive Levobupivacaine 5% + 1µg/kg fentanyl
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Patients will receive Levobupivacaine 5% + 1 µg/kg fentanyl
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
first analgesic request
Time Frame: 24 hours
|
first time to call for analgesia
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- McDonnell JG, O'Donnell B, Curley G, Heffernan A, Power C, Laffey JG. The analgesic efficacy of transversus abdominis plane block after abdominal surgery: a prospective randomized controlled trial. Anesth Analg. 2007 Jan;104(1):193-7. doi: 10.1213/01.ane.0000250223.49963.0f. Erratum In: Anesth Analg. 2007 May;104(5):1108.
- Elvir-Lazo OL, White PF. The role of multimodal analgesia in pain management after ambulatory surgery. Curr Opin Anaesthesiol. 2010 Dec;23(6):697-703. doi: 10.1097/ACO.0b013e32833fad0a.
- White PF, Kehlet H. Improving postoperative pain management: what are the unresolved issues? Anesthesiology. 2010 Jan;112(1):220-5. doi: 10.1097/ALN.0b013e3181c6316e. No abstract available.
- Sharma P, Chand T, Saxena A, Bansal R, Mittal A, Shrivastava U. Evaluation of postoperative analgesic efficacy of transversus abdominis plane block after abdominal surgery: A comparative study. J Nat Sci Biol Med. 2013 Jan;4(1):177-80. doi: 10.4103/0976-9668.107286.
- Aditianingsih D, Mochtar CA, Chandra S, Sukmono RB, Soamole IW. Comparison of Three-Quadrant Transversus Abdominis Plane Block and Continuous Epidural Block for Postoperative Analgesia After Transperitoneal Laparoscopic Nephrectomy. Anesth Pain Med. 2018 Sep 3;8(5):e80024. doi: 10.5812/aapm.80024. eCollection 2018 Oct.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2019
Primary Completion (Actual)
November 1, 2019
Study Completion (Actual)
December 1, 2019
Study Registration Dates
First Submitted
December 16, 2018
First Submitted That Met QC Criteria
December 16, 2018
First Posted (Actual)
December 19, 2018
Study Record Updates
Last Update Posted (Actual)
October 18, 2021
Last Update Submitted That Met QC Criteria
October 8, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Analgesics, Non-Narcotic
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Analgesics, Opioid
- Narcotics
- Hypnotics and Sedatives
- Adjuvants, Anesthesia
- Anesthetics, Local
- Fentanyl
- Dexmedetomidine
- Levobupivacaine
Other Study ID Numbers
- 17300222
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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