Herniorrhaphy, Nerve Block, Regional Anesthesia
Conditions
Brief summary
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.
Detailed description
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.
Interventions
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.
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.
Administered as part of the local anesthetic mixture
Administered as part of the local anesthetic mixture
Administered as part of the local anesthetic mixture
Sponsors
Study design
Eligibility
Inclusion criteria
* All patient's scheduled for elective unilateral open inguinal hernia repair at WFUBMC.
Exclusion criteria
* The anesthesiologist performing the intraoperative anesthetic deems the patient inappropriate for general anesthesia. * If the patient uses more than 40mg of Oxycodone equivalents per 24 hours or is on extended release opioid formulations. * If there is a contraindication to the performance of a regional block * Concomitant anticoagulation use * Allergy to local anesthetic * Infectious or dermatologic conditions in the area of block placement that would otherwise increase the risk of peripheral nerve blockade * Patient refusal * Pregnancy * Institutionalized individuals * Extremes of age: Age \> 90 or \< 18 * Non English speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Verbal Pain Score With Movement | 8 hrs Post Nerve Block | Assessed on an 11-point (0-10) numeric analog scale with a higher score denoting a worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Verbal Pain Score With Activity | 24hrs Post Nerve Block | Assessed on an 11 point (0-10) numeric analog scale with a higher score denoting a worse outcome |
| Time to First Oral Analgesic | 24hrs Post Nerve Block | When does the patient require their first post operative analgesic dose? |
| Time to Onset of Post Operative Pain | 24hrs Post Nerve Block | When does the patient first note post operative pain? |
| Post-operative Verbal Pain Score at Rest | 8 hrs Post Nerve Block | Assessed on an 11-point (0-10) numeric analog scale with a higher score denoting a worse outcome |
| 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--Vomiting | 8 hrs Post Nerve Block | — |
| Total Opioid Consumption | 24 hrs Post Nerve Block | Total opioids consumed during the first 24hrs post operatively. Measured as 24hr Oxycodone Equivalent |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 29 |
| 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 | 30 |
| Total | 59 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not meeting inclusion/exclusion | 1 | 0 |
Baseline characteristics
| Characteristic | Ilioinguinal / Iliohypogastric Block | Quadratus Lumborum Block | Total |
|---|---|---|---|
| Age, Continuous | 53.4 Years STANDARD_DEVIATION 18.6 | 58.9 Years STANDARD_DEVIATION 11.2 | 56.2 Years STANDARD_DEVIATION 14.84 |
| BMI | 25.2 kg/m^2 STANDARD_DEVIATION 4.3 | 26.4 kg/m^2 STANDARD_DEVIATION 6.2 | 25.8 kg/m^2 STANDARD_DEVIATION 5.2 |
| Race/Ethnicity, Customized African American | 10 Participants | 4 Participants | 14 Participants |
| Race/Ethnicity, Customized Caucasian | 17 Participants | 25 Participants | 42 Participants |
| Race/Ethnicity, Customized Hispanic | 2 Participants | 1 Participants | 3 Participants |
| Region of Enrollment United States | 29 participants | 30 participants | 59 participants |
| Sex: Female, Male Female | 3 Participants | 3 Participants | 6 Participants |
| Sex: Female, Male Male | 26 Participants | 27 Participants | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 30 |
| other Total, other adverse events | 12 / 29 | 12 / 30 |
| serious Total, serious adverse events | 0 / 29 | 0 / 30 |
Outcome results
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.
Time frame: 8 hrs Post Nerve Block
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ilioinguinal / Iliohypogastric Block | Post-operative Verbal Pain Score With Movement | 5.10 score on a scale | Standard Deviation 3.02 |
| Quadratus Lumborum Block | Post-operative Verbal Pain Score With Movement | 5.03 score on a scale | Standard Deviation 3.01 |
Number of Participants With Presence of Opioid Related Side Effects--Itching
Time frame: 8 hrs Post Nerve Block
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ilioinguinal / Iliohypogastric Block | Number of Participants With Presence of Opioid Related Side Effects--Itching | 0 Participants |
| Quadratus Lumborum Block | Number of Participants With Presence of Opioid Related Side Effects--Itching | 4 Participants |
Number of Participants With Presence of Opioid Related Side Effects--Itching
Time frame: 24 hrs Post Nerve Block
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ilioinguinal / Iliohypogastric Block | Number of Participants With Presence of Opioid Related Side Effects--Itching | 2 Participants |
| Quadratus Lumborum Block | Number of Participants With Presence of Opioid Related Side Effects--Itching | 3 Participants |
Number of Participants With Presence of Opioid Related Side Effects--Nausea
Time frame: 8 hrs Post Nerve Block
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ilioinguinal / Iliohypogastric Block | Number of Participants With Presence of Opioid Related Side Effects--Nausea | 9 Participants |
| Quadratus Lumborum Block | Number of Participants With Presence of Opioid Related Side Effects--Nausea | 5 Participants |
Number of Participants With Presence of Opioid Related Side Effects--Nausea
Time frame: 24 hrs Post Nerve Block
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ilioinguinal / Iliohypogastric Block | Number of Participants With Presence of Opioid Related Side Effects--Nausea | 6 Participants |
| Quadratus Lumborum Block | Number of Participants With Presence of Opioid Related Side Effects--Nausea | 3 Participants |
Number of Participants With Presence of Opioid Related Side Effects--Vomiting
Time frame: 24 hrs Post Nerve Block
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ilioinguinal / Iliohypogastric Block | Number of Participants With Presence of Opioid Related Side Effects--Vomiting | 3 Participants |
| Quadratus Lumborum Block | Number of Participants With Presence of Opioid Related Side Effects--Vomiting | 2 Participants |
Number of Participants With Presence of Opioid Related Side Effects--Vomiting
Time frame: 8 hrs Post Nerve Block
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ilioinguinal / Iliohypogastric Block | Number of Participants With Presence of Opioid Related Side Effects--Vomiting | 3 Participants |
| Quadratus Lumborum Block | Number of Participants With Presence of Opioid Related Side Effects--Vomiting | 3 Participants |
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
Time frame: 8 hrs Post Nerve Block
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ilioinguinal / Iliohypogastric Block | Post-operative Verbal Pain Score at Rest | 3.6 score on a scale | Standard Deviation 3 |
| Quadratus Lumborum Block | Post-operative Verbal Pain Score at Rest | 3.3 score on a scale | Standard Deviation 2.7 |
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
Time frame: 24 hrs Post Nerve Block
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ilioinguinal / Iliohypogastric Block | Post-operative Verbal Pain Score at Rest | 3 score on a scale | Standard Deviation 2.4 |
| Quadratus Lumborum Block | Post-operative Verbal Pain Score at Rest | 2.7 score on a scale | Standard Deviation 2.2 |
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
Time frame: 24hrs Post Nerve Block
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ilioinguinal / Iliohypogastric Block | Post-operative Verbal Pain Score With Activity | 4.9 score on a scale | Standard Deviation 2.5 |
| Quadratus Lumborum Block | Post-operative Verbal Pain Score With Activity | 5.3 score on a scale | Standard Deviation 2.4 |
Time to First Oral Analgesic
When does the patient require their first post operative analgesic dose?
Time frame: 24hrs Post Nerve Block
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ilioinguinal / Iliohypogastric Block | Time to First Oral Analgesic | 141 minutes |
| Quadratus Lumborum Block | Time to First Oral Analgesic | 91 minutes |
Time to Onset of Post Operative Pain
When does the patient first note post operative pain?
Time frame: 24hrs Post Nerve Block
Population: Data not collected
Total Opioid Consumption
Total opioids consumed during the first 24hrs post operatively. Measured as 24hr Oxycodone Equivalent
Time frame: 24 hrs Post Nerve Block
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ilioinguinal / Iliohypogastric Block | Total Opioid Consumption | 19.7 milligrams | Standard Deviation 19 |
| Quadratus Lumborum Block | Total Opioid Consumption | 25.2 milligrams | Standard Deviation 22 |