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Phase 2 N=60 Randomized Triple-blind Treatment

IINB vs. QLB for Elective Open Inguinal Herniorrhaphy

Nerve Block · Herniorrhaphy · Regional Anesthesia

Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcome: Primary: Post-operative Verbal Pain Score With Movement — 5.10; 5.03 score on a scale

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Ilioinguinal / Iliohypogastric Block (Procedure); Quadratus Lumborum Block (Procedure); Bupivacaine 0.25% (Drug); Epinephrine 1:200k (Drug); Clonidine 1.66mcg/cc (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Wake Forest University Health Sciences
Primary completion
Feb 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Post-operative Verbal Pain Score With Movement
5.10; 5.03
SECONDARY
Post-operative Verbal Pain Score at Rest
3; 2.7
SECONDARY
Post-operative Verbal Pain Score at Rest
3; 2.7
SECONDARY
Post-operative Verbal Pain Score With Activity
4.9; 5.3
SECONDARY
Time to First Oral Analgesic
141; 91
SECONDARY
Time to Onset of Post Operative Pain
SECONDARY
Total Opioid Consumption
19.7; 25.2
SECONDARY
Number of Participants With Presence of Opioid Related Side Effects--Nausea
6; 3
SECONDARY
Number of Participants With Presence of Opioid Related Side Effects--Itching
0; 4
SECONDARY
Number of Participants With Presence of Opioid Related Side Effects--Itching
0; 4
SECONDARY
Number of Participants With Presence of Opioid Related Side Effects--Vomiting
3; 2
SECONDARY
Number of Participants With Presence of Opioid Related Side Effects--Nausea
6; 3
SECONDARY
Number of Participants With Presence of Opioid Related Side Effects--Vomiting
3; 2

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03007966). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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