Nerve BlockPhase 2NCT03007966
IINB vs. QLB for Elective Open Inguinal Herniorrhaphy
A Phase 2 study testing Ilioinguinal / Iliohypogastric Block, Quadratus Lumborum Block and Bupivacaine 0.25% in people with Nerve Block and Herniorrhaphy, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Nerve Block, Herniorrhaphy, Regional Anesthesia
- What is being tested?
- Ilioinguinal / Iliohypogastric Block, Quadratus Lumborum Block and Bupivacaine 0.25%
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2017to 17 Feb 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patient's scheduled for elective unilateral open inguinal hernia repair at WFUBMC.
Who cannot join
- 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
Show all 11Show fewer
- Patient refusal
- Pregnancy
- Institutionalized individuals
- Extremes of age: Age > 90 or < 18
- Non English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
Official title: Ilioinguinal/Iliohypogastric vs. Quadratus Lumborum Nerve Blockade for Elective Open Inguinal Herniorrhaphy
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.
Read the 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.
- Conditions
- Nerve Block, Herniorrhaphy, Regional Anesthesia
- Being tested
- Ilioinguinal / Iliohypogastric Block, Quadratus Lumborum Block, Bupivacaine 0.25%, Epinephrine 1:200k, Clonidine 1.66mcg/cc
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ilioinguinal / Iliohypogastric BlockProcedure or surgery
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 BlockProcedure or surgery
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 1:200kDrug
Administered as part of the local anesthetic mixture
Clonidine 1.66mcg/ccDrug
Administered as part of the local anesthetic mixture
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Ilioinguinal / Iliohypogastric Block; Drug: Bupivacaine 0.25%; Drug: Epinephrine 1:200k; Drug: 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. Receives: Procedure: Quadratus Lumborum Block; Drug: Bupivacaine 0.25%; Drug: Epinephrine 1:200k; Drug: Clonidine 1.66mcg/cc |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 hrs Post Nerve Block
Secondary outcomes (12)
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
Measured: 8 hrs Post Nerve Block
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
Measured: 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
Measured: 24hrs Post Nerve Block
Time to First Oral Analgesic
When does the patient require their first post operative analgesic dose?
Measured: 24hrs Post Nerve Block
Time to Onset of Post Operative Pain
When does the patient first note post operative pain?
Measured: 24hrs Post Nerve Block
Total Opioid Consumption
Total opioids consumed during the first 24hrs post operatively. Measured as 24hr Oxycodone Equivalent
Measured: 24 hrs Post Nerve Block
Number of Participants With Presence of Opioid Related Side Effects--Nausea
Measured: 8 hrs Post Nerve Block
Number of Participants With Presence of Opioid Related Side Effects--Itching
Measured: 24 hrs Post Nerve Block
Number of Participants With Presence of Opioid Related Side Effects--Itching
Measured: 8 hrs Post Nerve Block
Number of Participants With Presence of Opioid Related Side Effects--Vomiting
Measured: 8 hrs Post Nerve Block
Number of Participants With Presence of Opioid Related Side Effects--Nausea
Measured: 24 hrs Post Nerve Block
Number of Participants With Presence of Opioid Related Side Effects--Vomiting
Measured: 24 hrs Post Nerve Block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2017 (estimated)
- Study start30 Jan 2017
- Primary completion17 Feb 2018
- Study completion17 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Nerve BlockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher J Edwards, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03007966
- Sponsor's protocol ID
- IRB00040354
- Status last verified
- Oct 2019
- First submitted
- 22 Dec 2016
- Last updated
- 18 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 15108988Toivonen 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.
PubMed 15025612Børglum 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)
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.
PubMed 12727037Willschke 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.
PubMed 15923270Schuirmann 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.
PubMed 34508487. Julious SA. Sample Sizes for Clinical Trials. Chapman and Hall/CRC, Boca Raton, FL, 2010.
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ilioinguinal/Iliohypogastric vs. Quadratus Lumborum Nerve Blockade for Elective Open Inguinal Herniorrhaphy
- ClinicalTrials.gov ID
- NCT03007966
- Acronym / sponsor ID
- IRB00040354
- Conditions
- Nerve Block, Herniorrhaphy, Regional Anesthesia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 30 Jan 2017 (actual)
- Primary completion
- 17 Feb 2018 (actual)
- Study completion
- 17 Feb 2018 (actual)
- First posted
- 2 Jan 2017 (estimated)
- Results
- Posted 18 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ilioinguinal / Iliohypogastric Block | Active comparator | Procedure: Ilioinguinal / Iliohypogastric Block, Drug: Bupivacaine 0.25%, Drug: Epinephrine 1:200k, Drug: Clonidine 1.66mcg/ccPatient'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 | Procedure: Quadratus Lumborum Block, Drug: Bupivacaine 0.25%, Drug: Epinephrine 1:200k, Drug: Clonidine 1.66mcg/ccPatient'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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patient's scheduled for elective unilateral open inguinal hernia repair at WFUBMC.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ilioinguinal / Iliohypogastric BlockPatients 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. | Procedure or surgery | Ilioinguinal / Iliohypogastric Block |
| Quadratus Lumborum BlockPatients 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. | Procedure or surgery | Quadratus Lumborum Block |
| Bupivacaine 0.25%Administered as part of the local anesthetic mixture | Drug | Ilioinguinal / Iliohypogastric Block, Quadratus Lumborum Block |
| Epinephrine 1:200kAdministered as part of the local anesthetic mixture | Drug | Ilioinguinal / Iliohypogastric Block, Quadratus Lumborum Block |
| Clonidine 1.66mcg/ccAdministered as part of the local anesthetic mixture | Drug | Ilioinguinal / Iliohypogastric Block, Quadratus Lumborum Block |
Primary outcome
Post-operative Verbal Pain Score With Movement
Time frame: 8 hrs Post Nerve Block
Assessed on an 11-point (0-10) numeric analog scale with a higher score denoting a worse outcome.
12 secondary outcomes
Post-operative Verbal Pain Score at Rest
Time frame: 8 hrs Post Nerve Block
Post-operative Verbal Pain Score at Rest
Time frame: 24 hrs Post Nerve Block
Post-operative Verbal Pain Score With Activity
Time frame: 24hrs Post Nerve Block
Time to First Oral Analgesic
Time frame: 24hrs Post Nerve Block
Time to Onset of Post Operative Pain
Time frame: 24hrs Post Nerve Block
Total Opioid Consumption
Time frame: 24 hrs Post Nerve Block
Number of Participants With Presence of Opioid Related Side Effects--Nausea
Time frame: 8 hrs Post Nerve Block
Number of Participants With Presence of Opioid Related Side Effects--Itching
Time frame: 24 hrs Post Nerve Block
Number of Participants With Presence of Opioid Related Side Effects--Itching
Time frame: 8 hrs Post Nerve Block
Number of Participants With Presence of Opioid Related Side Effects--Vomiting
Time frame: 8 hrs Post Nerve Block
Number of Participants With Presence of Opioid Related Side Effects--Nausea
Time frame: 24 hrs Post Nerve Block
Number of Participants With Presence of Opioid Related Side Effects--Vomiting
Time frame: 24 hrs Post Nerve Block
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15108988Williams 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.
- Background: PubMed 15025612Toivonen 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.
- BackgroundBørglum 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)
- Background: PubMed 12727037Farrar 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.
- Background: PubMed 15923270Willschke 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.
- Background: PubMed 3450848Schuirmann 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.
- Background7. Julious SA. Sample Sizes for Clinical Trials. Chapman and Hall/CRC, Boca Raton, FL, 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher J Edwards, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ilioinguinal / Iliohypogastric Block, Quadratus Lumborum Block and Bupivacaine 0.25% in people with Nerve Block and Herniorrhaphy, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative Verbal Pain Score With Movement (time frame: 8 hrs Post Nerve Block). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03007966, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2019.