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IINB vs. QLB for Elective Open Inguinal Herniorrhaphy

Ilioinguinal/Iliohypogastric vs. Quadratus Lumborum Nerve Blockade for Elective Open Inguinal Herniorrhaphy

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03007966
Enrollment
60
Registered
2017-01-02
Start date
2017-01-30
Completion date
2018-02-17
Last updated
2019-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Herniorrhaphy, Nerve Block, Regional Anesthesia

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

PROCEDUREIlioinguinal / 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.

PROCEDUREQuadratus 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.

DRUGBupivacaine 0.25%

Administered as part of the local anesthetic mixture

DRUGEpinephrine 1:200k

Administered as part of the local anesthetic mixture

DRUGClonidine 1.66mcg/cc

Administered as part of the local anesthetic mixture

Sponsors

Wake Forest University Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

MeasureTime frameDescription
Post-operative Verbal Pain Score With Movement8 hrs Post Nerve BlockAssessed on an 11-point (0-10) numeric analog scale with a higher score denoting a worse outcome.

Secondary

MeasureTime frameDescription
Post-operative Verbal Pain Score With Activity24hrs Post Nerve BlockAssessed on an 11 point (0-10) numeric analog scale with a higher score denoting a worse outcome
Time to First Oral Analgesic24hrs Post Nerve BlockWhen does the patient require their first post operative analgesic dose?
Time to Onset of Post Operative Pain24hrs Post Nerve BlockWhen does the patient first note post operative pain?
Post-operative Verbal Pain Score at Rest8 hrs Post Nerve BlockAssessed 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--Nausea8 hrs Post Nerve Block
Number of Participants With Presence of Opioid Related Side Effects--Itching24 hrs Post Nerve Block
Number of Participants With Presence of Opioid Related Side Effects--Vomiting8 hrs Post Nerve Block
Total Opioid Consumption24 hrs Post Nerve BlockTotal opioids consumed during the first 24hrs post operatively. Measured as 24hr Oxycodone Equivalent

Countries

United States

Participant flow

Participants by arm

ArmCount
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
Total59

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDid not meeting inclusion/exclusion10

Baseline characteristics

CharacteristicIlioinguinal / Iliohypogastric BlockQuadratus Lumborum BlockTotal
Age, Continuous53.4 Years
STANDARD_DEVIATION 18.6
58.9 Years
STANDARD_DEVIATION 11.2
56.2 Years
STANDARD_DEVIATION 14.84
BMI25.2 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 Participants4 Participants14 Participants
Race/Ethnicity, Customized
Caucasian
17 Participants25 Participants42 Participants
Race/Ethnicity, Customized
Hispanic
2 Participants1 Participants3 Participants
Region of Enrollment
United States
29 participants30 participants59 participants
Sex: Female, Male
Female
3 Participants3 Participants6 Participants
Sex: Female, Male
Male
26 Participants27 Participants53 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 290 / 30
other
Total, other adverse events
12 / 2912 / 30
serious
Total, serious adverse events
0 / 290 / 30

Outcome results

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.

Time frame: 8 hrs Post Nerve Block

ArmMeasureValue (MEAN)Dispersion
Ilioinguinal / Iliohypogastric BlockPost-operative Verbal Pain Score With Movement5.10 score on a scaleStandard Deviation 3.02
Quadratus Lumborum BlockPost-operative Verbal Pain Score With Movement5.03 score on a scaleStandard Deviation 3.01
Secondary

Number of Participants With Presence of Opioid Related Side Effects--Itching

Time frame: 8 hrs Post Nerve Block

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Ilioinguinal / Iliohypogastric BlockNumber of Participants With Presence of Opioid Related Side Effects--Itching0 Participants
Quadratus Lumborum BlockNumber of Participants With Presence of Opioid Related Side Effects--Itching4 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Ilioinguinal / Iliohypogastric BlockNumber of Participants With Presence of Opioid Related Side Effects--Itching2 Participants
Quadratus Lumborum BlockNumber of Participants With Presence of Opioid Related Side Effects--Itching3 Participants
Secondary

Number of Participants With Presence of Opioid Related Side Effects--Nausea

Time frame: 8 hrs Post Nerve Block

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Ilioinguinal / Iliohypogastric BlockNumber of Participants With Presence of Opioid Related Side Effects--Nausea9 Participants
Quadratus Lumborum BlockNumber of Participants With Presence of Opioid Related Side Effects--Nausea5 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Ilioinguinal / Iliohypogastric BlockNumber of Participants With Presence of Opioid Related Side Effects--Nausea6 Participants
Quadratus Lumborum BlockNumber of Participants With Presence of Opioid Related Side Effects--Nausea3 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Ilioinguinal / Iliohypogastric BlockNumber of Participants With Presence of Opioid Related Side Effects--Vomiting3 Participants
Quadratus Lumborum BlockNumber of Participants With Presence of Opioid Related Side Effects--Vomiting2 Participants
Secondary

Number of Participants With Presence of Opioid Related Side Effects--Vomiting

Time frame: 8 hrs Post Nerve Block

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Ilioinguinal / Iliohypogastric BlockNumber of Participants With Presence of Opioid Related Side Effects--Vomiting3 Participants
Quadratus Lumborum BlockNumber of Participants With Presence of Opioid Related Side Effects--Vomiting3 Participants
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

Time frame: 8 hrs Post Nerve Block

ArmMeasureValue (MEAN)Dispersion
Ilioinguinal / Iliohypogastric BlockPost-operative Verbal Pain Score at Rest3.6 score on a scaleStandard Deviation 3
Quadratus Lumborum BlockPost-operative Verbal Pain Score at Rest3.3 score on a scaleStandard Deviation 2.7
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

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.

ArmMeasureValue (MEAN)Dispersion
Ilioinguinal / Iliohypogastric BlockPost-operative Verbal Pain Score at Rest3 score on a scaleStandard Deviation 2.4
Quadratus Lumborum BlockPost-operative Verbal Pain Score at Rest2.7 score on a scaleStandard Deviation 2.2
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

Time frame: 24hrs Post Nerve Block

ArmMeasureValue (MEAN)Dispersion
Ilioinguinal / Iliohypogastric BlockPost-operative Verbal Pain Score With Activity4.9 score on a scaleStandard Deviation 2.5
Quadratus Lumborum BlockPost-operative Verbal Pain Score With Activity5.3 score on a scaleStandard Deviation 2.4
Secondary

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.

ArmMeasureValue (MEDIAN)
Ilioinguinal / Iliohypogastric BlockTime to First Oral Analgesic141 minutes
Quadratus Lumborum BlockTime to First Oral Analgesic91 minutes
Secondary

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

Secondary

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.

ArmMeasureValue (MEAN)Dispersion
Ilioinguinal / Iliohypogastric BlockTotal Opioid Consumption19.7 milligramsStandard Deviation 19
Quadratus Lumborum BlockTotal Opioid Consumption25.2 milligramsStandard Deviation 22

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026