Inguinal HerniaNBSSNCT06314815
Ilioinguinal-iliohypogastric Nerve Block Prior to Shouldice Inguinal Hernia Repair
An observational study of Inguinal Hernia and Pain, Postoperative, run by Shouldice Hospital at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 99 years
- Conditions the study is for
- Inguinal Hernia, Pain, Postoperative
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 11 Jan 2023to 15 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 16 to 99 years
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- Patients of all gender
- Shouldice repair due to a groin hernia operation at Shouldice Hospital.
Who cannot join
- Missing information in patient charts or patients are unable to be matched 1:1
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the detailed description
Routine preoperative care at Shouldice Hospital has not classically included the use of an ilioinguinal-iliohypogastric nerve block. However, with the purchase of an ultrasound machine and growing reports in the literature to the benefit of nerve blocks for inguinal hernia surgery1-5, it is now being trialed in patients at Shouldice Hospital.
There is limited research on the outcomes of ilioinguinal-iliohypogastric nerve block for inguinal hernia patients undergoing a Shouldice Repair, and none from the Shouldice Hospital, founder of the repair. One of the few reports evaluated patients who underwent a modified Shouldice Technique and not the actual repair2. Beaussier et al (2005), reported on 40 patients, 20 received local anesthesia with an ilioinguinal-iliohypogastric nerve block and 20 just received local anesthesia, and measured time to first analgesic request, pain intensity, and adverse events2. Their findings showed that the ilioinguinal-iliohypogastric nerve block with local anesthesia group had less pain during movement on postoperative day 3 but had an increased risk for orthostatic hypotension2. An even earlier study by Nehra et al (1995), divided 200 male inguinal hernia patients, who underwent a Shouldice Technique or modified Bassini repair, into 4 different treatment groups for comparison1. The groups included bupivacaine ilioinguinal field block with oral aspirin, bupivacaine ilioinguinal field block with oral placebo, saline with oral aspirin, and saline with oral placebo1. They measured pain scores, mobility, complications, patient experience, as well as opioid use1. The authors found that the bupivacaine ilioinguinal field block with oral aspirin group had decreased pain and opioid use, as well as increased mobility compared to groups that had saline with oral aspirin and saline with oral placebo1.
More recent research, focusing exclusively on the Lichtenstein repair for inguinal hernias, found that treatment groups had improved outcomes4,5. Kacmaz and Bolat (2020), compared 35 patients who received spinal anesthesia with 35 who received an ilioinguinal-iliohypogastric nerve block with tumescent anesthesia4. They measured sensory block onset time, patient satisfaction, postoperative opioid consumption, duration of surgery and first mobilization, length of hospital stay due to complications related to anesthetic method, and intraoperative hemodynamic values4. The authors found that in the nerve block group there was an increased duration of sensory block, intraoperative pain scores, and patient satisfaction, as well as lower postoperative pain scores, need for analgesics, and urinary retention, there was also early mobilization and discharge4. A 2023 study comparing 30 patients who received an ilioinguinal-iliohypogastric nerve block with added dexamethasone to 30 who just received a nerve block, found that the combination group had decreased rebound pain scores and opioid use5.
The purpose of this study is to evaluate the use of ilioinguinal-iliohypogastric nerve block for hernia patients at Shouldice Hospital. The results are expected to be useful in implementing the ilioinguinal-iliohypogastric nerve block within the patient population at Shouldice Hospital. Concurrently, aiding in understanding and potentially improving the current practices regarding pain management. This could enhance patient care and satisfaction, as well as provide valuable information about the utility of an ilioinguinal-iliohypogastric nerve block to the anesthetists and surgeons.
- Conditions
- Inguinal Hernia, Pain, Postoperative
- Keywords
- Inguinal hernia, Pain
- Medical subject headings
- Hernia, Inguinal, Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Aldrete scoring/system
Measured: 3 days after surgery
Determine sample size for future prospective trial.
Measured: 3 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start11 Jan 2023
- Primary completion10 Mar 2024
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inguinal HerniaStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shouldice Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marguerite Mainprize, Principal investigator, Shouldice Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06314815
- Sponsor's protocol ID
- Shouldice hospital
- Acronym
- NBSS
- Status last verified
- Mar 2024
- First submitted
- 11 Mar 2024
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ilioinguinal-iliohypogastric Nerve Block Prior to Shouldice Inguinal Hernia Repair
- ClinicalTrials.gov ID
- NCT06314815
- Acronym / sponsor ID
- NBSS / Shouldice hospital
- Conditions
- Inguinal Hernia, Pain, Postoperative
- Keywords
- Inguinal hernia, Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Shouldice HospitalUniversity, hospital or other
- Study start
- 11 Jan 2023 (actual)
- Primary completion
- 10 Mar 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 18 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Routine preoperative care at Shouldice Hospital has not classically included the use of an ilioinguinal-iliohypogastric nerve block. However, with the purchase of an ultrasound machine and growing reports in the literature to the benefit of nerve blocks for inguinal hernia surgery1-5, it is now being trialed in patients at Shouldice Hospital.
There is limited research on the outcomes of ilioinguinal-iliohypogastric nerve block for inguinal hernia patients undergoing a Shouldice Repair, and none from the Shouldice Hospital, founder of the repair. One of the few reports evaluated patients who underwent a modified Shouldice Technique and not the actual repair2. Beaussier et al (2005), reported on 40 patients, 20 received local anesthesia with an ilioinguinal-iliohypogastric nerve block and 20 just received local anesthesia, and measured time to first analgesic request, pain intensity, and adverse events2. Their findings showed that the ilioinguinal-iliohypogastric nerve block with local anesthesia group had less pain during movement on postoperative day 3 but had an increased risk for orthostatic hypotension2. An even earlier study by Nehra et al (1995), divided 200 male inguinal hernia patients, who underwent a Shouldice Technique or modified Bassini repair, into 4 different treatment groups for comparison1. The groups included bupivacaine ilioinguinal field block with oral aspirin, bupivacaine ilioinguinal field block with oral placebo, saline with oral aspirin, and saline with oral placebo1. They measured pain scores, mobility, complications, patient experience, as well as opioid use1. The authors found that the bupivacaine ilioinguinal field block with oral aspirin group had decreased pain and opioid use, as well as increased mobility compared to groups that had saline with oral aspirin and saline with oral placebo1.
More recent research, focusing exclusively on the Lichtenstein repair for inguinal hernias, found that treatment groups had improved outcomes4,5. Kacmaz and Bolat (2020), compared 35 patients who received spinal anesthesia with 35 who received an ilioinguinal-iliohypogastric nerve block with tumescent anesthesia4. They measured sensory block onset time, patient satisfaction, postoperative opioid consumption, duration of surgery and first mobilization, length of hospital stay due to complications related to anesthetic method, and intraoperative hemodynamic values4. The authors found that in the nerve block group there was an increased duration of sensory block, intraoperative pain scores, and patient satisfaction, as well as lower postoperative pain scores, need for analgesics, and urinary retention, there was also early mobilization and discharge4. A 2023 study comparing 30 patients who received an ilioinguinal-iliohypogastric nerve block with added dexamethasone to 30 who just received a nerve block, found that the combination group had decreased rebound pain scores and opioid use5.
The purpose of this study is to evaluate the use of ilioinguinal-iliohypogastric nerve block for hernia patients at Shouldice Hospital. The results are expected to be useful in implementing the ilioinguinal-iliohypogastric nerve block within the patient population at Shouldice Hospital. Concurrently, aiding in understanding and potentially improving the current practices regarding pain management. This could enhance patient care and satisfaction, as well as provide valuable information about the utility of an ilioinguinal-iliohypogastric nerve block to the anesthetists and surgeons.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 16 to 99 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients of all gender
- Shouldice repair due to a groin hernia operation at Shouldice Hospital.
Key exclusion criteria (1 listed)
- Missing information in patient charts or patients are unable to be matched 1:1
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Compare pain and pain medication use between patients receiving an ilioinguinal-iliohypogastric nerve block prior to hernia surgery with those who do not.
Time frame: 3 days after surgery
Aldrete scoring/system
2 secondary outcomes
Evaluate the impact of the ilioinguinal-iliohypogastric nerve block on patients with pain conditions, mental health conditions, and substance use histories.
Time frame: 3 days after surgery
Determine sample size for future prospective trial.
Time frame: 3 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Background1- 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.
- Individual participant dataSharing planned: Undecided
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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.
Marguerite Mainprize principal investigator
Shouldice Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inguinal Hernia and Pain, Postoperative, run by Shouldice Hospital at 1 site in Canada.
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 2 inclusion and 1 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 21 Mar 2024. 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 Canada. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Compare pain and pain medication use between patients receiving an ilioinguinal-iliohypogastric nerve block prior to hernia surgery with those who do not. (time frame: 3 days after surgery). 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 NCT06314815, which also lists 1 linked publication.
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 21 Mar 2024.