The Analgesic Efficacy of Two Bupivacaine Concentrations for Combined Ilioinguinal and Iliohypogastric Nerve Block in Postherniorrhaphy Pain
Primary Purpose
Hernia, Inguinal
Status
Not yet recruiting
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Bupivacaine
Dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Hernia, Inguinal focused on measuring nerve block
Eligibility Criteria
Inclusion Criteria: Patients between 21 and 60 years age with the American Society of Anesthesiologists' status I or II scheduled for elective primary open inguinal hernia repair Exclusion Criteria: Patient refusal. Body mass index (BMI) >40 kg m2. The presence of skin infection at the injection site. Allergy to local anesthetic drugs.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Patients will receive 10 ml of 0.5% bupivacaine
Patients will receive 10 ml of 0.25% bupivacaine
Arm Description
A 2mg dexamethasone will be added
A 2mg dexamethasone will be added
Outcomes
Primary Outcome Measures
The time to first request for rescue analgesia.
if score is ≥ 3 analgesia needed
Secondary Outcome Measures
The post-operative pain in the form of NRS.
The total 24 hour opioid consumption
The incidence of complication related to nerve block
urinary retention, hematoma, hypotension and arrhythmia
Patient satisfaction
in the form of 4 point satisfaction questionnaire: where 1 would be satisfied, 2=neutral, 3=dissatisfied, and 4=extremely dissatisfied.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05687981
Brief Title
The Analgesic Efficacy of Two Bupivacaine Concentrations for Combined Ilioinguinal and Iliohypogastric Nerve Block in Postherniorrhaphy Pain
Official Title
The Analgesic Efficacy of Two Bupivacaine Concentrations for Combined Ilioinguinal and Iliohypogastric Nerve Block in Postherniorrhaphy Pain.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2023 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The present study will be undertaken to compare the postoperative analgesic effect of 0.25% bupivacaine and 0.5% bupivacaine for unilateral ilioinguinal and Iliohypogastric nerve block after open inguinal hernia repair.
Primary outcome:
The time to first request for rescue analgesia.
Secondary outcome:
The post-operative pain in the form of NRS scores at rest & during movement at 0, 2, 4, 8, 12, 18 and 24 hours post-procedure.
The total 24 hour opioid consumption.
The incidence of complication related to nerve block (urinary retention, hematoma, hypotension and arrhythmia).
Patient satisfaction
Detailed Description
Postoperative pain is a common complication that may cause a neuroendocrine stress response, which is characterized by increased release of catabolic and immunosuppressive pituitary hormones and activation of the sympathetic nervous system. Excessive postoperative pain and the physiological stress response can influence postoperative outcomes, length of hospital stay and overall costs of hospital care Inguinal herniorrhaphy is a common outpatient surgical procedure with approximately 20 million operations performed worldwide annually.
Patients undergoing this procedure often experience moderate-to-severe pain, which can hinder post anesthesia care unit (PACU) discharge. While pain can be treated with opioid therapy, the literature supports that opioids may cause postoperative nausea, vomiting, hypoxia, and urinary retention. In contrast, analgesia provided by regional block has been shown to decrease the previous complications.
There is an ongoing interest in developing regional anesthetic techniques that may reduce or eliminate the use of opioid analgesics after minor surgical procedures such as hernia repair.
Regional analgesia has found wide acceptance both by the patients and their treating physicians, and therefore, it is now an important part of multimodal analgesia techniques. Ilioinguinal/iliohypogastric nerve block(IINB),transversus abdominis plane (TAP) block, paravertebral and rectus sheath, have all been used for providing analgesia following abdominal surgeries .
The combined ilioinguinal and iliohypogastric nerve block (IINB) is a commonly used technique for blockade of the ilioinguinal/iliohypogastric (IIIH) nerves and has been shown to decrease pain after OIH as well as reduce opioid requirements.
Bupivacaine belongs to the amide family, and its structure is similar to that of lidocaine. Bupivacaine is a potent agent capable of producing prolonged anesthesia. Its long duration of action plus its tendency to provide more sensory than motor block has made it a popular drug for providing prolonged analgesia during the postoperative period.
We assume that the use of higher concentration of bupivacaine in ilioinguinal and iliohypogastric nerve block (IINB) might increase the efficacy of post-operative analgesia and patient satisfaction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia, Inguinal
Keywords
nerve block
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients will receive 10 ml of 0.5% bupivacaine
Arm Type
Active Comparator
Arm Description
A 2mg dexamethasone will be added
Arm Title
Patients will receive 10 ml of 0.25% bupivacaine
Arm Type
Active Comparator
Arm Description
A 2mg dexamethasone will be added
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
the use of higher concentration of bupivacaine in ilioinguinal and iliohypogastric nerve block (IINB) might increase the efficacy of postoperative analgesia
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
2 mg dexamethasone
Primary Outcome Measure Information:
Title
The time to first request for rescue analgesia.
Description
if score is ≥ 3 analgesia needed
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
The post-operative pain in the form of NRS.
Time Frame
at 0, 2, 4, 8, 12, 18 and 24 hours post-procedure.
Title
The total 24 hour opioid consumption
Time Frame
24 hours
Title
The incidence of complication related to nerve block
Description
urinary retention, hematoma, hypotension and arrhythmia
Time Frame
48 hours
Title
Patient satisfaction
Description
in the form of 4 point satisfaction questionnaire: where 1 would be satisfied, 2=neutral, 3=dissatisfied, and 4=extremely dissatisfied.
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients between 21 and 60 years age with the American Society of Anesthesiologists' status I or II scheduled for elective primary open inguinal hernia repair
Exclusion Criteria:
Patient refusal.
Body mass index (BMI) >40 kg m2.
The presence of skin infection at the injection site.
Allergy to local anesthetic drugs.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mariam Elkasass
Phone
00201024234668
Email
mariam160758_pg@med.tanta.ed
First Name & Middle Initial & Last Name or Official Title & Degree
Alaa Abohager
Phone
00201099220281
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammad Abduallah
Organizational Affiliation
Tanta University
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
2265166
Citation
Bugedo GJ, Carcamo CR, Mertens RA, Dagnino JA, Munoz HR. Preoperative percutaneous ilioinguinal and iliohypogastric nerve block with 0.5% bupivacaine for post-herniorrhaphy pain management in adults. Reg Anesth. 1990 May-Jun;15(3):130-3.
Results Reference
background
PubMed Identifier
29720755
Citation
Kamal K, Jain P, Bansal T, Ahlawat G. A comparative study to evaluate ultrasound-guided transversus abdominis plane block versus ilioinguinal iliohypogastric nerve block for post-operative analgesia in adult patients undergoing inguinal hernia repair. Indian J Anaesth. 2018 Apr;62(4):292-297. doi: 10.4103/ija.IJA_548_17.
Results Reference
background
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The Analgesic Efficacy of Two Bupivacaine Concentrations for Combined Ilioinguinal and Iliohypogastric Nerve Block in Postherniorrhaphy Pain
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