Inguinal HerniaNCT03193723
Ultrasound Guided Local Anesthetic Field Block (A Five Step Procedure) for Open Inguinal Hernia Repair
A study testing US guided five step field block and Spinal anesthesia in people with Inguinal Hernia, run by Eslam Ayman Mohamed Shawki at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate success, efficacy, feasibility and safety of a simple five step ultrasound guided local anesthetic infiltration technique for unilateral open inguinal hernia repair and to determine the non-inferiority of the block to spinal anesthesia by comparing intraoperative and postoperative… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- US guided five step field block and Spinal anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2016to 1 Aug 2018
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA score I, II or Ш.
- Patients with unilateral inguinal hernia for elective open mesh repair hernioplasty operation.
Who cannot join
- Bilateral, recurrent or complicated inguinal hernia.
- Emergency operations or operation that lasts more than two hours.
- Patients with drug or alcohol abuse history.
- Chronic pain, with daily use of analgesics.
- Contraindication to local anesthesia.
- Contraindication of spinal anesthesia.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of medicine, Cairo University teaching hospitals (Kasr Alainy)
Cairo
About this study
Official title: Efficacy of Ultrasound Guided Local Anesthetic Field Block (A Five Step Procedure) as a Sole Anesthetic for Open Inguinal Hernia Repair Versus Spinal Anesthesia: A Randomized Controlled Study.
The aim of this study is to evaluate success, efficacy, feasibility and safety of a simple five step ultrasound guided local anesthetic infiltration technique for unilateral open inguinal hernia repair and to determine the non-inferiority of the block to spinal anesthesia by comparing intraoperative and postoperative complications, pain control and patient and surgeon satisfaction of the block with spinal anesthesia.
Read the detailed description
Open Inguinal hernia repair is one of the commonest procedures performed worldwide. Still, there is no consensus regarding the optimum anesthesia technique for this surgery. General, spinal, epidural and local anesthesia techniques have all been used, each having its own advantages and disadvantages.
General anesthesia carries risks of possible airway complications, postoperative deterioration of cognitive function, sore throat, nausea, vomiting and prolonged period of immobilization with associated risk of deep vein thrombosis and longer hospital stay. Spinal anesthesia, although effective, is not without risk in patients with decompensated heart disease, recent head injury, convulsions and coagulopathies. Also spinal and epidural anesthesia have been associated with hemodynamic instability, vomiting, urinary retention, post-dural puncture headache, and backache.
Use of pre-incision infiltration of local anesthetics for field blocks has been found to be an effective adjunct as well as an alternative to spinal and general anesthesia in many studies. Combined with sedation or on its own, it offers less cardiovascular instability, early ambulation and effective post-operative pain control. Also, it has been found to reduce hospital costs by 50% and gives better patient satisfaction.
Harvey Cushing and William Halsted first described the inguinal field block in 1900. since then, its efficacy and advantages have been compared by many surgeons and anesthesiologists in a number of studies. Refinements and modifications in the technique still continue. In 1963, Joseph L Ponka described in great detail a seven step procedure of performing it in 837 patients successfully.
In 1994, Parvis and colleagues did a step by step technique for local anesthetic infiltration field block for open inguinal hernia repair.
Ultrasonography is a safe and effective form of imaging. Over the past two decades, ultrasound equipment has become more compact, of higher quality and less expensive. Ultrasounds have been used to guide needle insertion and a number of approaches to nerves and plexuses have been reported. A clear advantage of the technique is that ultrasound produces "living pictures" or "real-time" images. The identification of neuronal and adjacent anatomical structures (blood vessels, peritoneum, bone, organs) along with the needle is another advantage. Moreover, anatomical variability may be responsible for block failures, and ultrasound technology enabling direct visualization may overcome this problem. Sonographic visualization allows for the performance of extra-epineurial needle tip positioning and administration of local anesthetic avoiding intra-epineurial injection.
A modification to the technique performed by Parvis and colleagues will be tested in this study. Our modification will be performing the technique under ultrasound guidance and completely before skin incision, which, to the best of our knowledge, was not attempted in the literature before.
Local anesthesia administered before skin incision produces longer postoperative analgesia because local infiltration theoretically inhibits the build-up of local nociceptive molecules and, therefore, there is better pain control in the postoperative period.This study aims at evaluating success, efficacy, feasibility and safety of a simple five step ultrasound guided local anesthetic infiltration technique for unilateral open inguinal hernia repair and also to compare intraoperative and postoperative complications and pain control of the block with spinal anesthesia.
- Conditions
- Inguinal Hernia
- Being tested
- US guided five step field block, Spinal anesthesia
- Keywords
- Hernia, Local anesthesia, ultrasound
- Medical subject headings
- Hernia, Inguinal, Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
US guided five step field blockProcedure or surgery
Ultrasound will guide needle insertion in the following layers (except intradermic injection):
- Subdermic infiltration. Approximately 8 milliliters
- Intradermic injection (making of the skin wheal). of approximately 6 milliliters.
- Deep subcutaneous injection. 8 milliliters of the mixture will be injected deep into the subcutaneous adipose
- Subfascial infiltration. Approximately eight milliliters of the anesthetic mixture will be injected immediately underneath the aponeurosis of the external oblique.
- Pubic tubercle and hernia sac injection. Occasionally, infiltration of ten milliliters of the mixture at the level of the pubic tubercle, around the neck and inside the indirect hernia sac
Spinal anesthesiaProcedure or surgery
Spinal anesthesia will be administered in sitting position, with 25 gauge Quincke spinal needle in L3-L4 intervertebral space, under all aseptic precautions and local infiltration, with 3.0 ml of 0.5% bupivacaine (heavy) after ensuring free, clear and adequate flow of cerebrospinal fluid. After giving spinal anesthesia, patient will be made to lie supine.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | US guided five step field block will be performed Receives: Procedure: US guided five step field block |
| Group B | Active comparator | Spinal anesthesia will be administered in sitting position Receives: Procedure: Spinal anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS 4 hours postoperative
Numerical Rating pain score 4 hours postoperative
Measured: 4 hours
Secondary outcomes (8)
NRS 30 minutes postoperative
Numerical Rating pain score 30 minutes postoperative.
Measured: 30 minutes
NRS 12 hours postoperative
Numerical Rating pain score 12 hours postoperative.
Measured: 12 hours
Time of first rescue analgesic dose
The time of request for the first rescue dose of analgesic medication
Measured: 12 hours
Total analgesic dose in the first 12 hours postoperative
The total doses of analgesics needed (whether opioids or non-opioids) to maintain an NRS score < 3 over the first 12 hours post-operative
Measured: 12 hours
Incidence of Side effects
Complications including nausea, vomiting, wound hematoma, hypotension, persistent headache and urinary retention
Measured: 12 hours
Time for ambulation
The time needed to start pain free unassisted ambulation and the duration of hospital stay.
Measured: 12 hours
Intra operative patient satisfaction
Intra operative patient satisfaction (rated as 1 to be very satisfied, 2 moderately satisfied and 3 poorly satisfied.)
Measured: 12 hours
Intra operative surgeon satisfaction
Intra operative surgeon satisfaction with the type of anesthesia (satisfied or not)
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2017
- Study start1 Oct 2016
- Primary completion1 Jul 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Randomized Controlled study.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eslam Ayman Mohamed Shawki
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eslam Ayman Mohamed Shawki, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03193723
- Sponsor's protocol ID
- UsHernia
- Status last verified
- Oct 2018
- First submitted
- 19 Jun 2017
- Last updated
- 4 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Anand A, Sinha PA, Kittappa K, Mulchandani MH, Debrah S, Brookstein R. Review of Inguinal Hernia Repairs by Various Surgical Techniques in a District General Hospital in the UK. Indian J Surg. 2011 Jan;73(1):13-8. doi: 10.1007/s12262-010-0156-7. Epub 2011 Jan 8.
PubMed 22211031Santos Gde C, Braga GM, Queiroz FL, Navarro TP, Gomez RS. Assessment of postoperative pain and hospital discharge after inguinal and iliohypogastric nerve block for inguinal hernia repair under spinal anesthesia: a prospective study. Rev Assoc Med Bras (1992). 2011 Sep-Oct;57(5):545-9. doi: 10.1590/s0104-42302011000500013. English, Portuguese.
PubMed 22012289Flanagan L Jr, Bascom JU. Repair of the groin hernia. Outpatient approach with local anesthesia. Surg Clin North Am. 1984 Apr;64(2):257-67. doi: 10.1016/s0039-6109(16)43283-4.
PubMed 6729669Belavy D, Cowlishaw PJ, Howes M, Phillips F. Ultrasound-guided transversus abdominis plane block for analgesia after Caesarean delivery. Br J Anaesth. 2009 Nov;103(5):726-30. doi: 10.1093/bja/aep235. Epub 2009 Aug 22.
PubMed 19700776Rozen WM, Tran TM, Ashton MW, Barrington MJ, Ivanusic JJ, Taylor GI. Refining the course of the thoracolumbar nerves: a new understanding of the innervation of the anterior abdominal wall. Clin Anat. 2008 May;21(4):325-33. doi: 10.1002/ca.20621.
PubMed 18428988Chanthong P, Abrishami A, Wong J, Herrera F, Chung F. Systematic review of questionnaires measuring patient satisfaction in ambulatory anesthesia. Anesthesiology. 2009 May;110(5):1061-7. doi: 10.1097/ALN.0b013e31819db079.
PubMed 19352161Prakash D, Heskin L, Doherty S, Galvin R. Local anaesthesia versus spinal anaesthesia in inguinal hernia repair: A systematic review and meta-analysis. Surgeon. 2017 Feb;15(1):47-57. doi: 10.1016/j.surge.2016.01.001. Epub 2016 Feb 16.
PubMed 26895656
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Ultrasound Guided Local Anesthetic Field Block (A Five Step Procedure) as a Sole Anesthetic for Open Inguinal Hernia Repair Versus Spinal Anesthesia: A Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT03193723
- Acronym / sponsor ID
- UsHernia
- Conditions
- Inguinal Hernia
- Keywords
- Hernia, Local anesthesia, ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Eslam Ayman Mohamed ShawkiUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 21 Jun 2017 (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 aim of this study is to evaluate success, efficacy, feasibility and safety of a simple five step ultrasound guided local anesthetic infiltration technique for unilateral open inguinal hernia repair and to determine the non-inferiority of the block to spinal anesthesia by comparing intraoperative and postoperative complications, pain control and patient and surgeon satisfaction of the block with spinal anesthesia.
Detailed description
Open Inguinal hernia repair is one of the commonest procedures performed worldwide. Still, there is no consensus regarding the optimum anesthesia technique for this surgery. General, spinal, epidural and local anesthesia techniques have all been used, each having its own advantages and disadvantages.
General anesthesia carries risks of possible airway complications, postoperative deterioration of cognitive function, sore throat, nausea, vomiting and prolonged period of immobilization with associated risk of deep vein thrombosis and longer hospital stay. Spinal anesthesia, although effective, is not without risk in patients with decompensated heart disease, recent head injury, convulsions and coagulopathies. Also spinal and epidural anesthesia have been associated with hemodynamic instability, vomiting, urinary retention, post-dural puncture headache, and backache.
Use of pre-incision infiltration of local anesthetics for field blocks has been found to be an effective adjunct as well as an alternative to spinal and general anesthesia in many studies. Combined with sedation or on its own, it offers less cardiovascular instability, early ambulation and effective post-operative pain control. Also, it has been found to reduce hospital costs by 50% and gives better patient satisfaction.
Harvey Cushing and William Halsted first described the inguinal field block in 1900. since then, its efficacy and advantages have been compared by many surgeons and anesthesiologists in a number of studies. Refinements and modifications in the technique still continue. In 1963, Joseph L Ponka described in great detail a seven step procedure of performing it in 837 patients successfully.
In 1994, Parvis and colleagues did a step by step technique for local anesthetic infiltration field block for open inguinal hernia repair.
Ultrasonography is a safe and effective form of imaging. Over the past two decades, ultrasound equipment has become more compact, of higher quality and less expensive. Ultrasounds have been used to guide needle insertion and a number of approaches to nerves and plexuses have been reported. A clear advantage of the technique is that ultrasound produces "living pictures" or "real-time" images. The identification of neuronal and adjacent anatomical structures (blood vessels, peritoneum, bone, organs) along with the needle is another advantage. Moreover, anatomical variability may be responsible for block failures, and ultrasound technology enabling direct visualization may overcome this problem. Sonographic visualization allows for the performance of extra-epineurial needle tip positioning and administration of local anesthetic avoiding intra-epineurial injection.
A modification to the technique performed by Parvis and colleagues will be tested in this study. Our modification will be performing the technique under ultrasound guidance and completely before skin incision, which, to the best of our knowledge, was not attempted in the literature before.
Local anesthesia administered before skin incision produces longer postoperative analgesia because local infiltration theoretically inhibits the build-up of local nociceptive molecules and, therefore, there is better pain control in the postoperative period.This study aims at evaluating success, efficacy, feasibility and safety of a simple five step ultrasound guided local anesthetic infiltration technique for unilateral open inguinal hernia repair and also to compare intraoperative and postoperative complications and pain control of the block with spinal anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A Randomized Controlled study.
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Procedure: US guided five step field blockUS guided five step field block will be performed |
| Group B | Active comparator | Procedure: Spinal anesthesiaSpinal anesthesia will be administered in sitting position |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA score I, II or Ш.
- Patients with unilateral inguinal hernia for elective open mesh repair hernioplasty operation.
Key exclusion criteria (6 listed)
- Bilateral, recurrent or complicated inguinal hernia.
- Emergency operations or operation that lasts more than two hours.
- Patients with drug or alcohol abuse history.
- Chronic pain, with daily use of analgesics.
- Contraindication to local anesthesia.
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 |
|---|---|---|
| US guided five step field blockUltrasound will guide needle insertion in the following layers (except intradermic injection): * Subdermic infiltration. Approximately 8 milliliters * Intradermic injection (making of the skin wheal). of approximately 6 milliliters. * Deep subcutaneous injection. 8 milliliters of the mixture will be injected deep into the subcutaneous adipose * Subfascial infiltration. Approximately eight milliliters of the anesthetic mixture will be injected immediately underneath the aponeurosis of the external oblique. * Pubic tubercle and hernia sac injection. Occasionally, infiltration of ten milliliters of the mixture at the level of the pubic tubercle, around the neck and inside the indirect hernia sac | Procedure or surgery | Group A |
| Spinal anesthesiaSpinal anesthesia will be administered in sitting position, with 25 gauge Quincke spinal needle in L3-L4 intervertebral space, under all aseptic precautions and local infiltration, with 3.0 ml of 0.5% bupivacaine (heavy) after ensuring free, clear and adequate flow of cerebrospinal fluid. After giving spinal anesthesia, patient will be made to lie supine. | Procedure or surgery | Group B |
Primary outcome
NRS 4 hours postoperative
Time frame: 4 hours
Numerical Rating pain score 4 hours postoperative
8 secondary outcomes
NRS 30 minutes postoperative
Time frame: 30 minutes
NRS 12 hours postoperative
Time frame: 12 hours
Time of first rescue analgesic dose
Time frame: 12 hours
Total analgesic dose in the first 12 hours postoperative
Time frame: 12 hours
Incidence of Side effects
Time frame: 12 hours
Time for ambulation
Time frame: 12 hours
Intra operative patient satisfaction
Time frame: 12 hours
Intra operative surgeon satisfaction
Time frame: 12 hours
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 4 Oct 2018.
- Background: PubMed 22211031Anand A, Sinha PA, Kittappa K, Mulchandani MH, Debrah S, Brookstein R. Review of Inguinal Hernia Repairs by Various Surgical Techniques in a District General Hospital in the UK. Indian J Surg. 2011 Jan;73(1):13-8. doi: 10.1007/s12262-010-0156-7. Epub 2011 Jan 8.
- Background: PubMed 22012289Santos Gde C, Braga GM, Queiroz FL, Navarro TP, Gomez RS. Assessment of postoperative pain and hospital discharge after inguinal and iliohypogastric nerve block for inguinal hernia repair under spinal anesthesia: a prospective study. Rev Assoc Med Bras (1992). 2011 Sep-Oct;57(5):545-9. doi: 10.1590/s0104-42302011000500013. English, Portuguese.
- Background: PubMed 6729669Flanagan L Jr, Bascom JU. Repair of the groin hernia. Outpatient approach with local anesthesia. Surg Clin North Am. 1984 Apr;64(2):257-67. doi: 10.1016/s0039-6109(16)43283-4.
- Background: PubMed 19700776Belavy D, Cowlishaw PJ, Howes M, Phillips F. Ultrasound-guided transversus abdominis plane block for analgesia after Caesarean delivery. Br J Anaesth. 2009 Nov;103(5):726-30. doi: 10.1093/bja/aep235. Epub 2009 Aug 22.
- Background: PubMed 18428988Rozen WM, Tran TM, Ashton MW, Barrington MJ, Ivanusic JJ, Taylor GI. Refining the course of the thoracolumbar nerves: a new understanding of the innervation of the anterior abdominal wall. Clin Anat. 2008 May;21(4):325-33. doi: 10.1002/ca.20621.
- Background: PubMed 19352161Chanthong P, Abrishami A, Wong J, Herrera F, Chung F. Systematic review of questionnaires measuring patient satisfaction in ambulatory anesthesia. Anesthesiology. 2009 May;110(5):1061-7. doi: 10.1097/ALN.0b013e31819db079.
- Background: PubMed 26895656Prakash D, Heskin L, Doherty S, Galvin R. Local anaesthesia versus spinal anaesthesia in inguinal hernia repair: A systematic review and meta-analysis. Surgeon. 2017 Feb;15(1):47-57. doi: 10.1016/j.surge.2016.01.001. Epub 2016 Feb 16.
- Individual participant dataSharing planned: No
Related trials for Inguinal Hernia
Recruiting
Permanent Versus Slowly Dissolving Stitches for Non-Mesh (Shouldice) Groin Hernia Repair
Inguinal Hernia
Recruiting
Watchful Waiting Versus Immediate Repair for Occult Contralateral Inguinal Hernias.
Inguinal Hernia Bilateral, Inguinal Hernia Unilateral
Recruiting
Primary Sac Abandonment and Distal Sac Fixation vs Complete Sac Dissection for Inguinoscrotal Hernias
Seroma, Inguinal Hernias
Recruiting
Comparing Two Laparoscopic Techniques for Hernia Repair in Children
Inguinal Hernia
Not yet recruiting
Lumbar ESP Block Versus TAP Block for Postoperative Pain Control in Children Undergoing Open Inguinal Hernia Repair
Inguinal Hernia, Postoperative Pain
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing US guided five step field block and Spinal anesthesia in people with Inguinal Hernia, run by Eslam Ayman Mohamed Shawki at 1 site in Egypt.
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 6 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 4 Oct 2018. 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 Egypt. 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?
NRS 4 hours postoperative (time frame: 4 hours). 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 NCT03193723, 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 4 Oct 2018.