Trial Outcomes & Findings for IINB vs. QLB for Elective Open Inguinal Herniorrhaphy (NCT NCT03007966)
NCT ID: NCT03007966
Last Updated: 2019-11-18
Results Overview
Assessed on an 11-point (0-10) numeric analog scale with a higher score denoting a worse outcome.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
8 hrs Post Nerve Block
Results posted on
2019-11-18
Participant Flow
Participant milestones
| Measure |
Ilioinguinal / Iliohypogastric Block
Patient's randomized to receive an Ilioinguinal / Iliohypogastric nerve block (IINB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a supine position in a manner consistent with the technique described by Willschke, but modified to utilize an in-plane technique rather than an out-of-plane technique for needle to ultrasound probe orientation. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.
Ilioinguinal / Iliohypogastric Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided ilioinguinal / iliohypogastric block technique.
|
Quadratus Lumborum Block
Patient's randomized to receive a Quadratus Lumborum block (QLB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a lateral position in a manner consistent with the technique described by Børglum. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.
Quadratus Lumborum Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided quadratus lumborum block technique.
Bupivacaine 0.25%: Administered as part of the local anesthetic mixture Epinephrine 1:200k: Administered as part of the local anesthetic mixture Clonidine 1.66mcg/c
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
29
|
30
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Ilioinguinal / Iliohypogastric Block
Patient's randomized to receive an Ilioinguinal / Iliohypogastric nerve block (IINB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a supine position in a manner consistent with the technique described by Willschke, but modified to utilize an in-plane technique rather than an out-of-plane technique for needle to ultrasound probe orientation. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.
Ilioinguinal / Iliohypogastric Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided ilioinguinal / iliohypogastric block technique.
|
Quadratus Lumborum Block
Patient's randomized to receive a Quadratus Lumborum block (QLB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a lateral position in a manner consistent with the technique described by Børglum. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.
Quadratus Lumborum Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided quadratus lumborum block technique.
Bupivacaine 0.25%: Administered as part of the local anesthetic mixture Epinephrine 1:200k: Administered as part of the local anesthetic mixture Clonidine 1.66mcg/c
|
|---|---|---|
|
Overall Study
Did not meeting inclusion/exclusion
|
1
|
0
|
Baseline Characteristics
IINB vs. QLB for Elective Open Inguinal Herniorrhaphy
Baseline characteristics by cohort
| Measure |
Ilioinguinal / Iliohypogastric Block
n=29 Participants
Patient's randomized to receive an Ilioinguinal / Iliohypogastric nerve block (IINB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a supine position in a manner consistent with the technique described by Willschke, but modified to utilize an in-plane technique rather than an out-of-plane technique for needle to ultrasound probe orientation. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.
Ilioinguinal / Iliohypogastric Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided ilioinguinal / iliohypogastric block technique.
|
Quadratus Lumborum Block
n=30 Participants
Patient's randomized to receive a Quadratus Lumborum block (QLB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a lateral position in a manner consistent with the technique described by Børglum. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.
Quadratus Lumborum Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided quadratus lumborum block technique.
Bupivacaine 0.25%: Administered as part of the local anesthetic mixture Epinephrine 1:200k: Administered as part of the local anesthetic mixture Clonidine 1.66mcg/c
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.4 Years
STANDARD_DEVIATION 18.6 • n=5 Participants
|
58.9 Years
STANDARD_DEVIATION 11.2 • n=7 Participants
|
56.2 Years
STANDARD_DEVIATION 14.84 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
17 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=5 Participants
|
30 participants
n=7 Participants
|
59 participants
n=5 Participants
|
|
BMI
|
25.2 kg/m^2
STANDARD_DEVIATION 4.3 • n=5 Participants
|
26.4 kg/m^2
STANDARD_DEVIATION 6.2 • n=7 Participants
|
25.8 kg/m^2
STANDARD_DEVIATION 5.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: 8 hrs Post Nerve BlockAssessed on an 11-point (0-10) numeric analog scale with a higher score denoting a worse outcome.
Outcome measures
| Measure |
Ilioinguinal / Iliohypogastric Block
n=29 Participants
Patient's randomized to receive an Ilioinguinal / Iliohypogastric nerve block (IINB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a supine position in a manner consistent with the technique described by Willschke, but modified to utilize an in-plane technique rather than an out-of-plane technique for needle to ultrasound probe orientation. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.
Ilioinguinal / Iliohypogastric Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided ilioinguinal / iliohypogastric block technique.
|
Quadratus Lumborum Block
n=30 Participants
Patient's randomized to receive a Quadratus Lumborum block (QLB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a lateral position in a manner consistent with the technique described by Børglum. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.
Quadratus Lumborum Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided quadratus lumborum block technique.
Bupivacaine 0.25%: Administered as part of the local anesthetic mixture Epinephrine 1:200k: Administered as part of the local anesthetic mixture Clonidine 1.66mcg/c
|
|---|---|---|
|
Post-operative Verbal Pain Score With Movement
|
5.10 score on a scale
Standard Deviation 3.02
|
5.03 score on a scale
Standard Deviation 3.01
|
SECONDARY outcome
Timeframe: 8 hrs Post Nerve BlockAssessed on an 11-point (0-10) numeric analog scale with a higher score denoting a worse outcome
Outcome measures
| Measure |
Ilioinguinal / Iliohypogastric Block
n=29 Participants
Patient's randomized to receive an Ilioinguinal / Iliohypogastric nerve block (IINB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a supine position in a manner consistent with the technique described by Willschke, but modified to utilize an in-plane technique rather than an out-of-plane technique for needle to ultrasound probe orientation. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.
Ilioinguinal / Iliohypogastric Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided ilioinguinal / iliohypogastric block technique.
|
Quadratus Lumborum Block
n=30 Participants
Patient's randomized to receive a Quadratus Lumborum block (QLB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a lateral position in a manner consistent with the technique described by Børglum. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.
Quadratus Lumborum Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided quadratus lumborum block technique.
Bupivacaine 0.25%: Administered as part of the local anesthetic mixture Epinephrine 1:200k: Administered as part of the local anesthetic mixture Clonidine 1.66mcg/c
|
|---|---|---|
|
Post-operative Verbal Pain Score at Rest
|
3.6 score on a scale
Standard Deviation 3
|
3.3 score on a scale
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: 24 hrs Post Nerve BlockPopulation: One patient was lost to follow up in the Ilioinguinal Block arm after the 8 hour post block time point which is why the patient flow number for that arm differs from the 24 hour time frame.
Assessed on an 11 point (0-10) numeric analog scale with a higher score denoting a worse outcome
Outcome measures
| Measure |
Ilioinguinal / Iliohypogastric Block
n=28 Participants
Patient's randomized to receive an Ilioinguinal / Iliohypogastric nerve block (IINB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a supine position in a manner consistent with the technique described by Willschke, but modified to utilize an in-plane technique rather than an out-of-plane technique for needle to ultrasound probe orientation. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.
Ilioinguinal / Iliohypogastric Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided ilioinguinal / iliohypogastric block technique.
|
Quadratus Lumborum Block
n=30 Participants
Patient's randomized to receive a Quadratus Lumborum block (QLB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a lateral position in a manner consistent with the technique described by Børglum. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.
Quadratus Lumborum Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided quadratus lumborum block technique.
Bupivacaine 0.25%: Administered as part of the local anesthetic mixture Epinephrine 1:200k: Administered as part of the local anesthetic mixture Clonidine 1.66mcg/c
|
|---|---|---|
|
Post-operative Verbal Pain Score at Rest
|
3 score on a scale
Standard Deviation 2.4
|
2.7 score on a scale
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: 24hrs Post Nerve BlockAssessed on an 11 point (0-10) numeric analog scale with a higher score denoting a worse outcome
Outcome measures
| Measure |
Ilioinguinal / Iliohypogastric Block
n=28 Participants
Patient's randomized to receive an Ilioinguinal / Iliohypogastric nerve block (IINB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a supine position in a manner consistent with the technique described by Willschke, but modified to utilize an in-plane technique rather than an out-of-plane technique for needle to ultrasound probe orientation. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.
Ilioinguinal / Iliohypogastric Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided ilioinguinal / iliohypogastric block technique.
|
Quadratus Lumborum Block
n=30 Participants
Patient's randomized to receive a Quadratus Lumborum block (QLB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a lateral position in a manner consistent with the technique described by Børglum. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.
Quadratus Lumborum Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided quadratus lumborum block technique.
Bupivacaine 0.25%: Administered as part of the local anesthetic mixture Epinephrine 1:200k: Administered as part of the local anesthetic mixture Clonidine 1.66mcg/c
|
|---|---|---|
|
Post-operative Verbal Pain Score With Activity
|
4.9 score on a scale
Standard Deviation 2.5
|
5.3 score on a scale
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: 24hrs Post Nerve BlockPopulation: One patient was lost to follow up in the Ilioinguinal Block arm after the 8 hour post block time point which is why the patient flow number for that arm differs from the 24 hour time frame.
When does the patient require their first post operative analgesic dose?
Outcome measures
| Measure |
Ilioinguinal / Iliohypogastric Block
n=28 Participants
Patient's randomized to receive an Ilioinguinal / Iliohypogastric nerve block (IINB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a supine position in a manner consistent with the technique described by Willschke, but modified to utilize an in-plane technique rather than an out-of-plane technique for needle to ultrasound probe orientation. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.
Ilioinguinal / Iliohypogastric Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided ilioinguinal / iliohypogastric block technique.
|
Quadratus Lumborum Block
n=30 Participants
Patient's randomized to receive a Quadratus Lumborum block (QLB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a lateral position in a manner consistent with the technique described by Børglum. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.
Quadratus Lumborum Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided quadratus lumborum block technique.
Bupivacaine 0.25%: Administered as part of the local anesthetic mixture Epinephrine 1:200k: Administered as part of the local anesthetic mixture Clonidine 1.66mcg/c
|
|---|---|---|
|
Time to First Oral Analgesic
|
141 minutes
Interval 71.0 to 742.0
|
91 minutes
Interval 58.0 to 390.0
|
SECONDARY outcome
Timeframe: 24hrs Post Nerve BlockPopulation: Data not collected
When does the patient first note post operative pain?
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 hrs Post Nerve BlockPopulation: One patient was lost to follow up in the Ilioinguinal Block arm after the 8 hour post block time point which is why the patient flow number for that arm differs from the 24 hour time frame.
Total opioids consumed during the first 24hrs post operatively. Measured as 24hr Oxycodone Equivalent
Outcome measures
| Measure |
Ilioinguinal / Iliohypogastric Block
n=28 Participants
Patient's randomized to receive an Ilioinguinal / Iliohypogastric nerve block (IINB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a supine position in a manner consistent with the technique described by Willschke, but modified to utilize an in-plane technique rather than an out-of-plane technique for needle to ultrasound probe orientation. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.
Ilioinguinal / Iliohypogastric Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided ilioinguinal / iliohypogastric block technique.
|
Quadratus Lumborum Block
n=30 Participants
Patient's randomized to receive a Quadratus Lumborum block (QLB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a lateral position in a manner consistent with the technique described by Børglum. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.
Quadratus Lumborum Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided quadratus lumborum block technique.
Bupivacaine 0.25%: Administered as part of the local anesthetic mixture Epinephrine 1:200k: Administered as part of the local anesthetic mixture Clonidine 1.66mcg/c
|
|---|---|---|
|
Total Opioid Consumption
|
19.7 milligrams
Standard Deviation 19
|
25.2 milligrams
Standard Deviation 22
|
SECONDARY outcome
Timeframe: 8 hrs Post Nerve BlockOutcome measures
| Measure |
Ilioinguinal / Iliohypogastric Block
n=29 Participants
Patient's randomized to receive an Ilioinguinal / Iliohypogastric nerve block (IINB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a supine position in a manner consistent with the technique described by Willschke, but modified to utilize an in-plane technique rather than an out-of-plane technique for needle to ultrasound probe orientation. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.
Ilioinguinal / Iliohypogastric Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided ilioinguinal / iliohypogastric block technique.
|
Quadratus Lumborum Block
n=30 Participants
Patient's randomized to receive a Quadratus Lumborum block (QLB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a lateral position in a manner consistent with the technique described by Børglum. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.
Quadratus Lumborum Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided quadratus lumborum block technique.
Bupivacaine 0.25%: Administered as part of the local anesthetic mixture Epinephrine 1:200k: Administered as part of the local anesthetic mixture Clonidine 1.66mcg/c
|
|---|---|---|
|
Number of Participants With Presence of Opioid Related Side Effects--Nausea
|
9 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 24 hrs Post Nerve BlockPopulation: One patient was lost to follow up in the Ilioinguinal Block arm after the 8 hour post block time point which is why the patient flow number for that arm differs from the 24 hour time frame.
Outcome measures
| Measure |
Ilioinguinal / Iliohypogastric Block
n=28 Participants
Patient's randomized to receive an Ilioinguinal / Iliohypogastric nerve block (IINB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a supine position in a manner consistent with the technique described by Willschke, but modified to utilize an in-plane technique rather than an out-of-plane technique for needle to ultrasound probe orientation. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.
Ilioinguinal / Iliohypogastric Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided ilioinguinal / iliohypogastric block technique.
|
Quadratus Lumborum Block
n=30 Participants
Patient's randomized to receive a Quadratus Lumborum block (QLB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a lateral position in a manner consistent with the technique described by Børglum. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.
Quadratus Lumborum Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided quadratus lumborum block technique.
Bupivacaine 0.25%: Administered as part of the local anesthetic mixture Epinephrine 1:200k: Administered as part of the local anesthetic mixture Clonidine 1.66mcg/c
|
|---|---|---|
|
Number of Participants With Presence of Opioid Related Side Effects--Itching
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 8 hrs Post Nerve BlockOutcome measures
| Measure |
Ilioinguinal / Iliohypogastric Block
n=29 Participants
Patient's randomized to receive an Ilioinguinal / Iliohypogastric nerve block (IINB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a supine position in a manner consistent with the technique described by Willschke, but modified to utilize an in-plane technique rather than an out-of-plane technique for needle to ultrasound probe orientation. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.
Ilioinguinal / Iliohypogastric Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided ilioinguinal / iliohypogastric block technique.
|
Quadratus Lumborum Block
n=30 Participants
Patient's randomized to receive a Quadratus Lumborum block (QLB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a lateral position in a manner consistent with the technique described by Børglum. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.
Quadratus Lumborum Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided quadratus lumborum block technique.
Bupivacaine 0.25%: Administered as part of the local anesthetic mixture Epinephrine 1:200k: Administered as part of the local anesthetic mixture Clonidine 1.66mcg/c
|
|---|---|---|
|
Number of Participants With Presence of Opioid Related Side Effects--Itching
|
0 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 8 hrs Post Nerve BlockOutcome measures
| Measure |
Ilioinguinal / Iliohypogastric Block
n=29 Participants
Patient's randomized to receive an Ilioinguinal / Iliohypogastric nerve block (IINB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a supine position in a manner consistent with the technique described by Willschke, but modified to utilize an in-plane technique rather than an out-of-plane technique for needle to ultrasound probe orientation. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.
Ilioinguinal / Iliohypogastric Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided ilioinguinal / iliohypogastric block technique.
|
Quadratus Lumborum Block
n=30 Participants
Patient's randomized to receive a Quadratus Lumborum block (QLB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a lateral position in a manner consistent with the technique described by Børglum. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.
Quadratus Lumborum Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided quadratus lumborum block technique.
Bupivacaine 0.25%: Administered as part of the local anesthetic mixture Epinephrine 1:200k: Administered as part of the local anesthetic mixture Clonidine 1.66mcg/c
|
|---|---|---|
|
Number of Participants With Presence of Opioid Related Side Effects--Vomiting
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 24 hrs Post Nerve BlockPopulation: One patient was lost to follow up in the Ilioinguinal Block arm after the 8 hour post block time point which is why the patient flow number for that arm differs from the 24 hour time frame.
Outcome measures
| Measure |
Ilioinguinal / Iliohypogastric Block
n=28 Participants
Patient's randomized to receive an Ilioinguinal / Iliohypogastric nerve block (IINB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a supine position in a manner consistent with the technique described by Willschke, but modified to utilize an in-plane technique rather than an out-of-plane technique for needle to ultrasound probe orientation. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.
Ilioinguinal / Iliohypogastric Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided ilioinguinal / iliohypogastric block technique.
|
Quadratus Lumborum Block
n=30 Participants
Patient's randomized to receive a Quadratus Lumborum block (QLB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a lateral position in a manner consistent with the technique described by Børglum. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.
Quadratus Lumborum Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided quadratus lumborum block technique.
Bupivacaine 0.25%: Administered as part of the local anesthetic mixture Epinephrine 1:200k: Administered as part of the local anesthetic mixture Clonidine 1.66mcg/c
|
|---|---|---|
|
Number of Participants With Presence of Opioid Related Side Effects--Nausea
|
6 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 24 hrs Post Nerve BlockPopulation: One patient was lost to follow up in the Ilioinguinal Block arm after the 8 hour post block time point which is why the patient flow number for that arm differs from the 24 hour time frame.
Outcome measures
| Measure |
Ilioinguinal / Iliohypogastric Block
n=28 Participants
Patient's randomized to receive an Ilioinguinal / Iliohypogastric nerve block (IINB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a supine position in a manner consistent with the technique described by Willschke, but modified to utilize an in-plane technique rather than an out-of-plane technique for needle to ultrasound probe orientation. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.
Ilioinguinal / Iliohypogastric Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided ilioinguinal / iliohypogastric block technique.
|
Quadratus Lumborum Block
n=30 Participants
Patient's randomized to receive a Quadratus Lumborum block (QLB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a lateral position in a manner consistent with the technique described by Børglum. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.
Quadratus Lumborum Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided quadratus lumborum block technique.
Bupivacaine 0.25%: Administered as part of the local anesthetic mixture Epinephrine 1:200k: Administered as part of the local anesthetic mixture Clonidine 1.66mcg/c
|
|---|---|---|
|
Number of Participants With Presence of Opioid Related Side Effects--Vomiting
|
3 Participants
|
2 Participants
|
Adverse Events
Ilioinguinal / Iliohypogastric Block
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Quadratus Lumborum Block
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ilioinguinal / Iliohypogastric Block
n=29 participants at risk
Patient's randomized to receive an Ilioinguinal / Iliohypogastric nerve block (IINB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a supine position in a manner consistent with the technique described by Willschke, but modified to utilize an in-plane technique rather than an out-of-plane technique for needle to ultrasound probe orientation. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.
Ilioinguinal / Iliohypogastric Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided ilioinguinal / iliohypogastric block technique.
|
Quadratus Lumborum Block
n=30 participants at risk
Patient's randomized to receive a Quadratus Lumborum block (QLB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a lateral position in a manner consistent with the technique described by Børglum. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.
Quadratus Lumborum Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided quadratus lumborum block technique.
Bupivacaine 0.25%: Administered as part of the local anesthetic mixture Epinephrine 1:200k: Administered as part of the local anesthetic mixture Clonidine 1.66mcg/c
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
41.4%
12/29 • 8 - 24 hours
|
26.7%
8/30 • 8 - 24 hours
|
|
Gastrointestinal disorders
Vomiting
|
20.7%
6/29 • 8 - 24 hours
|
16.7%
5/30 • 8 - 24 hours
|
|
Skin and subcutaneous tissue disorders
Itching
|
6.9%
2/29 • 8 - 24 hours
|
23.3%
7/30 • 8 - 24 hours
|
Additional Information
Christopher Edwards
Wake Forest University Health Sciences
Phone: 336-716-4498
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place