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Open inguinal herniorrhaphy is a common outpatient surgical procedure. Post-operative pain can be a significant hindrance to discharge from the post anesthesia care unit. Pain can be treated with opioid therapy, but the literature supports that these agents are known to create or exacerbate adverse effects and complications, including post-operative nausea and vomiting, hypoxia, and urinary retention. In contrast, analgesia provided by regional anesthesia results in a decreased risk of the aforementioned complications.1 Because of this, various regional anesthetic techniques have been developed to provide analgesia following open herniorrhaphy. One technique is a combined ilioinguinal and iliohypogastric nerve block (IINB), which has been shown to decrease the initial pain after inguinal herniorrhaphy.2 The quadratus lumborum block (QLB) is a newer regional anesthetic technique that we think could be as effective as IINB at providing pain control following open herniorrhaphy. Additionally, because local anesthetic injected during a QLB has the potential to spread cranially into the thoracic paravertebral space following its lumbar deposition it could lead to alleviation of both somatic and visceral pain.3 This might therefore improve the quality and or duration of analgesia as compared to the IINB. To the best of the author's knowledge there has been no investigation comparing the efficacy, with regards to post-operative pain management, between IINB and QLB.
This study will be a double-blinded prospective randomized controlled equivalency trial comparing QLB to IINB. Patients presenting for unilateral open inguinal herniorrhaphy who agree to participate in the study and do not meet exclusion criteria will be randomized to either receiving an IINB or a QLB for post-operative analgesia. After performing a timeout, applying monitors (ECG, capnography, Sp02, non-invasive blood pressure), and confirming all paperwork per the usual pre-procedural check list the study participants will be administered procedural sedation (fentanyl and midazolam) to comfort as well as supplemental oxygen. The anatomy of both block sites will be identified by palpation of landmarks, labeling of structures with a skin marking pen, and visualization under ultrasound guidance. Both sites will be administered a small skin wheal of lidocaine 1% at the site the block needle would be introduced into the skin. Our intent with regards to administering a local anesthetic skin wheal is to increase our success in blinding the patient to which block was actually performed. A regional anesthetic block will only be performed at the randomized block site (IINB vs. QLB). After 15-30 minutes post block or post operatively the block will be assessed for success. Loss of cold sensation in the area of the surgical site would be indicative of block success. The patient will then proceed to the operating room and receive a general anesthetic with the final details of that anesthetic to be determined by the anesthesiologist responsible for the patient in the operating room. We will ask the operating room anesthesiologist and surgeon to avoid administration of medications that would confound our results. Specifically, no additional local anesthetic is to be injected at the incision site, no long acting opioids (hydromorphone, morphine, methadone etc…), dexamethasone or ketamine. After completion of the procedure the patient will recover in the post anesthesia care unit (PACU) where the participant will recover as per the usual process. The patient's discharge disposition will be at the discretion of the surgeon and anesthesiologist responsible for the participant's PACU care. The patient will be provided a diary that the participant will complete at 8hrs and 24hrs post block that will help the participant compile the data pertinent to the investigators primary and secondary outcomes. This diary should take no more than a minute or two for each sampling time. Participants will receive two phone calls at home to obtain this data at 8hrs and 24hrs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ilioinguinal / Iliohypogastric Block | Active Comparator | 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. |
|
| Quadratus Lumborum Block | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ilioinguinal / Iliohypogastric Block | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Verbal Pain Score With Movement | Assessed on an 11-point (0-10) numeric analog scale with a higher score denoting a worse outcome. | 8 hrs Post Nerve Block |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Verbal Pain Score at Rest | Assessed on an 11-point (0-10) numeric analog scale with a higher score denoting a worse outcome | 8 hrs Post Nerve Block |
| Post-operative Verbal Pain Score at Rest |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher J Edwards, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | 27157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15108988 | Background | Williams BA, Kentor ML, Vogt MT, Vogt WB, Coley KC, Williams JP, Roberts MS, Chelly JE, Harner CD, Fu FH. Economics of nerve block pain management after anterior cruciate ligament reconstruction: potential hospital cost savings via associated postanesthesia care unit bypass and same-day discharge. Anesthesiology. 2004 Mar;100(3):697-706. doi: 10.1097/00000542-200403000-00034. | |
| 15025612 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Post-operative Verbal Pain Score With Movement | Assessed on an 11-point (0-10) numeric analog scale with a higher score denoting a worse outcome. | Posted | Mean | Standard Deviation | score on a scale | 8 hrs Post Nerve Block |
|
8 - 24 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christopher Edwards | Wake Forest University Health Sciences | 336-716-4498 | chedward@wakehealth.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 18, 2016 | Nov 14, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D004837 | Epinephrine |
| D003000 | Clonidine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Quadratus Lumborum Block | Procedure | 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% | Drug | Administered as part of the local anesthetic mixture |
|
| Epinephrine 1:200k | Drug | Administered as part of the local anesthetic mixture |
|
| Clonidine 1.66mcg/cc | Drug | Administered as part of the local anesthetic mixture |
|
Assessed on an 11 point (0-10) numeric analog scale with a higher score denoting a worse outcome
| 24 hrs Post Nerve Block |
| Post-operative Verbal Pain Score With Activity | Assessed on an 11 point (0-10) numeric analog scale with a higher score denoting a worse outcome | 24hrs Post Nerve Block |
| Time to First Oral Analgesic | When does the patient require their first post operative analgesic dose? | 24hrs Post Nerve Block |
| Time to Onset of Post Operative Pain | When does the patient first note post operative pain? | 24hrs Post Nerve Block |
| Total Opioid Consumption | Total opioids consumed during the first 24hrs post operatively. Measured as 24hr Oxycodone Equivalent | 24 hrs Post Nerve Block |
| Number of Participants With Presence of Opioid Related Side Effects--Nausea | 8 hrs Post Nerve Block |
| Number of Participants With Presence of Opioid Related Side Effects--Itching | 24 hrs Post Nerve Block |
| Number of Participants With Presence of Opioid Related Side Effects--Itching | 8 hrs Post Nerve Block |
| Number of Participants With Presence of Opioid Related Side Effects--Vomiting | 8 hrs Post Nerve Block |
| Number of Participants With Presence of Opioid Related Side Effects--Nausea | 24 hrs Post Nerve Block |
| Number of Participants With Presence of Opioid Related Side Effects--Vomiting | 24 hrs Post Nerve Block |
| Background |
| Toivonen J, Permi J, Rosenberg PH. Analgesia and discharge following preincisional ilioinguinal and iliohypogastric nerve block combined with general or spinal anaesthesia for inguinal herniorrhaphy. Acta Anaesthesiol Scand. 2004 Apr;48(4):480-5. doi: 10.1111/j.1399-6576.2004.00346.x. |
| Background | Børglum J, Jensen K, Moriggl B, et al. Ultrasound-Guided Transmuscular Quadratus Lumborum Blockade. BJA Out Blue E-Letters 2013. Available from http://bja.oxfordjournals. org/forum/topic/brjana_el%3B9919 (accessed 16 December 2015) |
| 12727037 | Background | Farrar JT, Berlin JA, Strom BL. Clinically important changes in acute pain outcome measures: a validation study. J Pain Symptom Manage. 2003 May;25(5):406-11. doi: 10.1016/s0885-3924(03)00162-3. |
| 15923270 | Background | Willschke H, Marhofer P, Bosenberg A, Johnston S, Wanzel O, Cox SG, Sitzwohl C, Kapral S. Ultrasonography for ilioinguinal/iliohypogastric nerve blocks in children. Br J Anaesth. 2005 Aug;95(2):226-30. doi: 10.1093/bja/aei157. Epub 2005 May 27. |
| 3450848 | Background | Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm. 1987 Dec;15(6):657-80. doi: 10.1007/BF01068419. |
| Background | 7. Julious SA. Sample Sizes for Clinical Trials. Chapman and Hall/CRC, Boca Raton, FL, 2010. |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Median | Standard Deviation | kg/m^2 |
|
| OG001 | 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 |
|
|
| Secondary | Post-operative Verbal Pain Score at Rest | Assessed on an 11-point (0-10) numeric analog scale with a higher score denoting a worse outcome | Posted | Mean | Standard Deviation | score on a scale | 8 hrs Post Nerve Block |
|
|
|
| Secondary | Post-operative Verbal Pain Score at Rest | Assessed on an 11 point (0-10) numeric analog scale with a higher score denoting a worse outcome | 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. | Posted | Mean | Standard Deviation | score on a scale | 24 hrs Post Nerve Block |
|
|
|
| Secondary | Post-operative Verbal Pain Score With Activity | Assessed on an 11 point (0-10) numeric analog scale with a higher score denoting a worse outcome | Posted | Mean | Standard Deviation | score on a scale | 24hrs Post Nerve Block |
|
|
|
| Secondary | Time to First Oral Analgesic | When does the patient require their first post operative analgesic dose? | 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. | Posted | Median | 95% Confidence Interval | minutes | 24hrs Post Nerve Block |
|
|
|
| Secondary | Time to Onset of Post Operative Pain | When does the patient first note post operative pain? | Data not collected | Posted | 24hrs Post Nerve Block |
|
|
| Secondary | Total Opioid Consumption | Total opioids consumed during the first 24hrs post operatively. Measured as 24hr Oxycodone Equivalent | 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. | Posted | Mean | Standard Deviation | milligrams | 24 hrs Post Nerve Block |
|
|
|
| Secondary | Number of Participants With Presence of Opioid Related Side Effects--Nausea | Posted | Count of Participants | Participants | 8 hrs Post Nerve Block |
|
|
|
| Secondary | Number of Participants With Presence of Opioid Related Side Effects--Itching | 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. | Posted | Count of Participants | Participants | 24 hrs Post Nerve Block |
|
|
|
| Secondary | Number of Participants With Presence of Opioid Related Side Effects--Itching | Posted | Count of Participants | Participants | 8 hrs Post Nerve Block |
|
|
|
| Secondary | Number of Participants With Presence of Opioid Related Side Effects--Vomiting | Posted | Count of Participants | Participants | 8 hrs Post Nerve Block |
|
|
|
| Secondary | Number of Participants With Presence of Opioid Related Side Effects--Nausea | 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. | Posted | Count of Participants | Participants | 24 hrs Post Nerve Block |
|
|
|
| Secondary | Number of Participants With Presence of Opioid Related Side Effects--Vomiting | 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. | Posted | Count of Participants | Participants | 24 hrs Post Nerve Block |
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 12 |
| 29 |
| EG001 | 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 | 0 | 30 | 0 | 30 | 12 | 30 |
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Itching | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D000588 |
| Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D048288 | Imidazolines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |