Dexmedetomidine to Levobupivacaine for Transversus Abdominis Plane Block in Elderly Patients Undergoing Inguinal Hernia Repair Surgery
Primary Purpose
Dexmedetomidine, Fentanyl
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Levobupivacaine
Dexmedetomidine Hydrochloride
Fentanyl
Sponsored by
About this trial
This is an interventional treatment trial for Dexmedetomidine
Eligibility Criteria
Inclusion Criteria:
- ASA status I, II, and III patients,
- aged 60-75 y,
- both male and female,
- undergoing inguinal hernia repair surgery.
Exclusion Criteria:
- 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.
Sites / Locations
- Assiut governorate
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Group L
LD group
LF group
Arm Description
30 Patients will receive Levobupivacaine 5%
30 patients will receive Levobupivacaine 5% + 1 µg/kg dexmedetomidine.
30 patients will receive Levobupivacaine 5% + 1µg/kg fentanyl
Outcomes
Primary Outcome Measures
first analgesic request
time for the first analgesia rescue call.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04971759
Brief Title
Dexmedetomidine to Levobupivacaine for Transversus Abdominis Plane Block in Elderly Patients Undergoing Inguinal Hernia Repair Surgery
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?
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
December 30, 2020 (Actual)
Study Completion Date
February 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dexmedetomidine, Fentanyl
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group L
Arm Type
Experimental
Arm Description
30 Patients will receive Levobupivacaine 5%
Arm Title
LD group
Arm Type
Experimental
Arm Description
30 patients will receive Levobupivacaine 5% + 1 µg/kg dexmedetomidine.
Arm Title
LF group
Arm Type
Experimental
Arm Description
30 patients will receive Levobupivacaine 5% + 1µg/kg fentanyl
Intervention Type
Drug
Intervention Name(s)
Levobupivacaine
Intervention Description
Levobupivacaine 5%
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine Hydrochloride
Intervention Description
Levobupivacaine 5% + 1 µg/kg dexmedetomidine.
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Intervention Description
Levobupivacaine 5% + 1µg/kg fentanyl
Primary Outcome Measure Information:
Title
first analgesic request
Description
time for the first analgesia rescue call.
Time Frame
24 hours postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ASA status I, II, and III patients,
aged 60-75 y,
both male and female,
undergoing inguinal hernia repair surgery.
Exclusion Criteria:
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.
Facility Information:
Facility Name
Assiut governorate
City
Assiut
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
23160979
Citation
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.
Results Reference
result
PubMed Identifier
23355160
Citation
Favuzza 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 Reference
result
PubMed Identifier
23389068
Citation
Walter 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.
Results Reference
result
Learn more about this trial
Dexmedetomidine to Levobupivacaine for Transversus Abdominis Plane Block in Elderly Patients Undergoing Inguinal Hernia Repair Surgery
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