NCT06314815

Brief Summary

The introduction of ilioinguinal-iliohypogastric nerve blocks into the preoperative care regimen at Shouldice Hospital for inguinal hernia repair marks a significant shift in pain management strategies. While Shouldice Hospital has traditionally not employed this technique, recent literature highlighting its potential benefits has prompted its trial within their patient population. Research in this area, although limited, suggests promising outcomes. Studies such as those by Beaussier et al. (2005) and Nehra et al. (1995) have demonstrated decreased postoperative pain and opioid use, as well as increased mobility associated with the use of ilioinguinal-iliohypogastric nerve blocks. However, concerns such as orthostatic hypotension and rebound pain have also been noted, indicating the need for careful consideration and monitoring of potential adverse effects. More recent studies, particularly those focusing on the Lichtenstein repair, have further supported the potential benefits of ilioinguinal-iliohypogastric nerve blocks. Kacmaz and Bolat (2020) found improved patient satisfaction, reduced opioid consumption, and shorter hospital stays associated with nerve block techniques. Additionally, the use of adjuncts such as dexamethasone has shown promise in reducing rebound pain and opioid requirements postoperatively. The purpose of evaluating the use of ilioinguinal-iliohypogastric nerve blocks at Shouldice Hospital is multifaceted. Not only does it aim to enhance patient care and satisfaction by improving pain management strategies, but it also provides valuable insights for anesthetists and surgeons regarding the utility and efficacy of this technique within the context of inguinal hernia repair. Furthermore, the trial may facilitate the refinement of current practices, potentially leading to standardized protocols that optimize patient outcomes while minimizing adverse effects. In summary, the introduction of ilioinguinal-iliohypogastric nerve blocks at Shouldice Hospital represents a proactive approach toward enhancing perioperative care for inguinal hernia patients. By leveraging emerging evidence and adapting to evolving clinical practices, the hospital stands to benefit from improved patient outcomes and potentially contribute to the advancement of pain management strategies in hernia surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 11, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2024

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 11, 2024

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 18, 2024

Completed
Last Updated

March 21, 2024

Status Verified

March 1, 2024

Enrollment Period

1.2 years

First QC Date

March 11, 2024

Last Update Submit

March 19, 2024

Conditions

Keywords

Inguinal herniaPain

Outcome Measures

Primary Outcomes (1)

  • Compare pain and pain medication use between patients receiving an ilioinguinal-iliohypogastric nerve block prior to hernia surgery with those who do not.

    Aldrete scoring/system

    3 days after surgery

Secondary Outcomes (2)

  • Evaluate the impact of the ilioinguinal-iliohypogastric nerve block on patients with pain conditions, mental health conditions, and substance use histories.

    3 days after surgery

  • Determine sample size for future prospective trial.

    3 days after surgery

Study Arms (2)

1

Patients that received the ilioinguinal-iliohypogastric nerve block \[IINB\] were chosen by the anesthetists prior to surgery based on patient suitability, consultation with patients, and availability of time and resources. The Ilioinguinal-iliohypogastric nerve block contained one of 0.5% Bupivacaine and 2% Lidocaine, 0.5% Marcaine and 2% Lidocaine, 0.25% Marcaine with Epinephrine, 0.25% or 0.1% Bupivacaine 2ith 2% Lidocaine (mixtures such as: 0.5% Bupivacaine (also called Marcaine) and 2% Lidocaine, with or without Epinephrine mix).

2

Matched patients in terms of biometric and peroperative data, who did not receive an Ilioinguinal-iliohypogastric nerve block.

Eligibility Criteria

Age16 Years - 99 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The population will focus on all patients that had a hernia operation at Shouldice Hospital. The exclusion criteria are if there is missing information in patient charts or patients are unable to be matched 1:1. As this is the first study of its kind at Shouldice Hospital the required sample size is unknown, and we intend to include a small pilot analysis. The patients that receive the ilioinguinal-iliohypogastric nerve block are having it administered in the operating room when on the table. The onset of the block is within minutes and lasts up to 12 hours after administration. The ilioinguinal-iliohypogastric nerve block is an option for almost everyone and may provide additional support for patients with lower pain thresholds and/or substance use issues. There is no difference in postoperative course for those patients who do and do not receive the nerve block, and there are no additional risks.

You may qualify if:

  • Patients of all gender
  • Shouldice repair due to a groin hernia operation at Shouldice Hospital.

You may not qualify if:

  • Missing information in patient charts or patients are unable to be matched 1:1

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shouldice hospital

Thornhill, Ontario, L3T 4A3, Canada

Location

Related Publications (1)

  • 1- Nehra D, Gemmell L, Pye JK. Pain relief after inguinal hernia repair: a randomized double-blind study. Br J Surg. 1995;82(9):1245-7. https://doi.org/10.1002/bjs.1800820929 2- Beaussier M, Weickmans H, Abdelhalim Z, Lienhart A. Inguinal herniorrhaphy under monitored anesthesia care with ilioinguinal-iliohypogastric block: the impact of adding clonidine to ropivacaine. Anesth Analg. 2005;101(6):1659-62. https://doi.org/10.1213/01.ANE.0000184046.64631.50 3- Stav A, Reytman L, Stav MY, Troitsa A, Kirshon M, Alfici R, Dudkiewicz M, and Sternberg A. Transversus abdominis plane versus ilioinguinal and iliohypogastric nerve blocks for analgesia following open inguinal herniorrhaphy. Rambam Maimonides Medical Journal. 2016;7(3). 4- Kacmaz M and Bolat H. Comparison of spinal anaesthsia versus ilioinguinal-iliohypogastric nerve block applied with tumescent anaesthsia for single-sided inguinal hernia. Hernia. 2020;24;1049-1056. 5- Korkusuz M, Basaran B, Et T, Bilge A, Yarimoglu R, and Kurucay Y. The effects of dexamethasone added to ilioinguinal/iliohypogastric nerve (IIN/IHN) block on rebound pain in inguinal hernia surgery: a randomized controlled trial. Hernia. 2023. https://doi.org/10.1007/s10029-023-02841-9.

    BACKGROUND

MeSH Terms

Conditions

Hernia, InguinalPain, PostoperativePain

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic ProcessesNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Marguerite Mainprize

    Shouldice Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2024

First Posted

March 18, 2024

Study Start

January 11, 2023

Primary Completion

March 10, 2024

Study Completion

March 15, 2024

Last Updated

March 21, 2024

Record last verified: 2024-03

Locations