Inguinal HerniaNCT04792164
Effect of Ultra-Sound Guided Pre-emptive Nerve Block on Post-operative Pain Following Open Inguinal Hernia Repair.
A study testing Ultra sound guided nerve block and Usual infiltration in people with Inguinal Hernia, run by Imam Abdulrahman Bin Faisal University.
Trial summary
A hernia occurs when an organ 'like intestines' or fatty tissue protrude through a weak point in muscle or connective tissue and one of the most common types of hernia is inguinal. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Ultra sound guided nerve block and Usual infiltration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2021to 29 Jun 2023
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who underwent elective inguinal hernia repair (will consider the hernia size).
- Age from 18-70. (70 with no other comorbiditeis)
- Their ASA score 1,2 or 3 (American Society of Anesthesia)
- General Anesthesia.
- Open inguinal hernia repair.
Who cannot join
- All emergency inguinal hernia repair and recurrent hernia.
- Children and pregnant women.
- Patients having regional anesthesia. (Spinal/Local).
- Laparoscopic inguinal hernia.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Ultra-Sound Guided Pre-emptive Nerve Block on Post-operative Pain Following Open Inguinal Hernia Repair: Randomised Control Trial
A hernia occurs when an organ 'like intestines' or fatty tissue protrude through a weak point in muscle or connective tissue and one of the most common types of hernia is inguinal. Inguinal hernia defined as a bulge in the inguinal region or scrotum, may be accompanied by dull or burning pain, which worsens by exercise or cough. There are 2 types of inguinal hernia: direct and indirect. Direct inguinal hernia occurs because of a defect or weakness in the transversalis fascia area of the Hesselbach triangle. On the other hand, the indirect inguinal hernia which is the most common inguinal hernia follows the tract of inguinal canal and result from a persistent processus vaginalis.
Immediate pain after inguinal herniorrhaphy delays the ambulation which leads to delay in the hospital discharge. Besides that, is the chronic pain that affect 50% of patients which is an important issue that needs to be dealt with.
Our aim of this study, is to compare between postoperative period in the patients who received US guided nerve block and in patients who received infiltration only before open inguinal hernia repair, and to show that pre-emptive local anaesthesia will result in better pain control, less postoperative complication, earlier mobilisation, earlier recovery and less analgesia consumption by patients.
Read the detailed description
In this study our aim in detail is to:
- Asses the outcomes (early postoperative pain management in day case "day 1,2,3, 30 and 3 month and 6 month" , length of hospital stay, analgesia consumption، recovery to work, driving and usual activity) of the US guided nerve block in patients who underwent inguinal hernia repair comparing to patient who received only skin infiltration.
- Evaluate the advantages of the US guided nerve block in postoperative inguinal hernia repair patients.
- Demonstrate its compatibly as a one day procedure (less length of hospital stay), with earlier return to work and driving and recovery in general.
- Compare our result with other international studies result.
Study in details:
it is Randomised Control Trial, Double blinded (patients and recruiter), study will be conducted in King Fahd University Hospital, Khobar, Eastern Province, Saudi Arabia. It contains 2 Arms ,Two Parallel groups. The experimental group will receive US guided nerve block and the control group will receive usual infiltration. Lidocaine+ Marcaine will be used in both group with same concentration (1%+.25%). The random allocation will be done using simple random allocation with a help of the following software (random.org).
Will compare the two groups regarding, a questionary with visual analogue will be distributed and data will be collected by recruiters regarding pain scale, length of hospital stay, return to work, return to driving and usual activity, and analgesia consumption post operative, all in day 1,2,3,4,30,3 month and 6 month post operatives (details in outcome section).
We are expecting to have a reduction in pain score from severe to moderate, about 20% in experimental group, and reducing the length of hospital stay from 1-2 days to one day procedure. And reduction in consumption of Analgesia postoperative.
our sample size will be 134 with a power of 80% and an effect size of 0.5, will include all patients who will have inguinal hernia repair and meet our inclusion criteria, in period of 12-18 months starting after obtaining of IRB approval.
- Inclusion criteria:
- Patients who underwent elective inguinal hernia repair (will consider the hernia size).
- Age from 18-70.
- Their ASA score 1,2 or 3 (American Society of Anesthesia)
- Operation under general anaesthesia.
- Open inguinal hernia repair.
- Exclusion criteria:
- All emergency inguinal hernia repair and recurrent hernia.
- Children and pregnant women.
- Patients having regional anaesthesia. (Spinal/Local).
- Laparoscopic inguinal hernia.
Data Management and analysis plan:
- SPSS latest version will be used for data analysis.
- Summary statistic will be obtained as frequency, and percentage for qualitative data, and means, medians and standard deviations from continuous variables.
- Analysis will be done by epidemiologist and biostatistician.
Ethical Considerations:
- Our study does not have any physical, psychological, social, legal, economic risk.
- The study will be reviewed by IRB, ethics committee; then the approval will be obtained.
- Written approval will be obtained from the patients prior to the procedure.
- Preemptive analgesia and infiltration are usually used in our practice and aim to compare.
- Conditions
- Inguinal Hernia
- Being tested
- Ultra sound guided nerve block, Usual infiltration
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultra sound guided nerve blockProcedure or surgery
Ultra sound guided nerve block by lidocaine before open inguinal hernia repair.
Usual infiltrationProcedure or surgery
Usual infiltration by lidocaine before open inguinal hernia repair.
| Study group | Role | What they receive |
|---|---|---|
| The experimental group will receive US guided nerve block | Experimental | The experimental group will receive US guided nerve block by lidocaine before open inguinal hernia repair. Receives: Procedure: Ultra sound guided nerve block |
| The control group will receive usual infiltration | Other | The control group will receive usual infiltration by lidocaine before open inguinal hernia repair. Receives: Procedure: Usual infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scale (from 1 to 10) 1 is the minimum and 10 the maximum pain severity.
Assessment of pain scale post operative, lower score mean a better outcome.
Measured: Day 1 postoperative.
Pain Scale (from 1 to 10) 1 is the minimum and 10 the maximum pain severity.
Assessment of pain scale post operative, lower score mean a better outcome.
Measured: Day 2 postoperative.
Pain Scale (from 1 to 10) 1 is the minimum and 10 the maximum pain severity.
Assessment of pain scale post operative, lower score mean a better outcome.
Measured: Day 3 postoperative.
Pain Scale (from 1 to 10) 1 is the minimum and 10 the maximum pain severity.
Assessment of pain scale post operative, lower score mean a better outcome.
Measured: Day 4 postoperative.
Pain Scale (from 1 to 10) 1 is the minimum and 10 the maximum pain severity.
Assessment of pain scale post operative, lower score mean a better outcome.
Measured: Day 30 postoperative.
Pain Scale (from 1 to 10) 1 is the minimum and 10 the maximum pain severity.
Assessment of pain scale post operative, lower score mean a better outcome.
Measured: 3 month postoperative for chronic pain.
Pain Scale (from 1 to 10) 1 is the minimum and 10 the maximum pain severity.
Assessment of pain scale post operative, lower score mean a better outcome.
Measured: 6 month postoperative for chronic pain.
Assessment of early mobilisation.
When the patient started to mobilise? assessed by monitoring the patients postoperative and record when he started to mobilise.
Measured: Day 1 postoperative period.
Assessment of early mobilisation.
When the patient started to mobilise? assessed by monitoring the patients postoperative and record when he started to mobilise.
Measured: Day 2 postoperative period.
Assessment of early mobilisation.
When the patient started to mobilise? assessed by monitoring the patients postoperative and record when he started to mobilise.
Measured: Day 3 postoperative period.
Retain to driving (how many days between surgery and patient back to dive)
When the patient back to drive his car? assessed by monitoring the patients postoperative and record when he started to drive the car again.
Measured: Postoperative period up to 8 weeks.
Retain to work (how many days between surgery and patient back to his work)
When the patient back to his work or usual activity? assessed by monitoring the patients postoperative and record when he started to work again.
Measured: Postoperative period up to 8 weeks.
Length of hospital stay (in days).
Length of hospital stay post open inguinal hernia repair ( how many days patient spend in the hospital postoperative).
Measured: immediately after the surgery until patient discharged.
Frequency of analgesia consumption postoperative.
Analgesia consumption by patient postoperative (How frequent patient taking analgesia postoperative).
Measured: Day 1 postoperative.
Frequency of analgesia consumption postoperative.
Analgesia consumption by patient postoperative (How frequent patient taking analgesia postoperative).
Measured: Day 2 postoperative.
Frequency of analgesia consumption postoperative.
Analgesia consumption by patient postoperative (How frequent patient taking analgesia postoperative).
Measured: Day 3 postoperative.
Frequency of analgesia consumption postoperative.
Analgesia consumption by patient postoperative (How frequent patient taking analgesia postoperative).
Measured: Day 4 postoperative.
Frequency of analgesia consumption postoperative.
Analgesia consumption by patient postoperative (How frequent patient taking analgesia postoperative).
Measured: Day 5 postoperative.
Frequency of analgesia consumption postoperative.
Analgesia consumption by patient postoperative (How frequent patient taking analgesia postoperative).
Measured: Day 6 postoperative.
Frequency of analgesia consumption postoperative.
Analgesia consumption by patient postoperative (How frequent patient taking analgesia postoperative).
Measured: Day 7 postoperative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start1 Dec 2021 (estimated)
- Primary completion29 Dec 2022 (estimated)
- Study completion29 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 Arms Arm1) The experimental group will receive US guided nerve block by Lidocaine+Marcaine concentration (1%+.25%). Arm2) The control group will receive usual infiltration by Lidocaine+Marcaine concentration (1%+.25%).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imam Abdulrahman Bin Faisal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nasser Mohamed Amer, Imam Abdulrahman Bin Faisal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04792164
- Sponsor's protocol ID
- USG-PENB-IHR
- Status last verified
- Oct 2021
- First submitted
- 9 Feb 2021
- Last updated
- 2 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ultra-Sound Guided Pre-emptive Nerve Block on Post-operative Pain Following Open Inguinal Hernia Repair: Randomised Control Trial
- ClinicalTrials.gov ID
- NCT04792164
- Acronym / sponsor ID
- USG-PENB-IHR
- Conditions
- Inguinal Hernia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Imam Abdulrahman Bin Faisal UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 29 Dec 2022 (estimated)
- Study completion
- 29 Jun 2023 (estimated)
- First posted
- 10 Mar 2021 (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.
A hernia occurs when an organ 'like intestines' or fatty tissue protrude through a weak point in muscle or connective tissue and one of the most common types of hernia is inguinal. Inguinal hernia defined as a bulge in the inguinal region or scrotum, may be accompanied by dull or burning pain, which worsens by exercise or cough. There are 2 types of inguinal hernia: direct and indirect. Direct inguinal hernia occurs because of a defect or weakness in the transversalis fascia area of the Hesselbach triangle. On the other hand, the indirect inguinal hernia which is the most common inguinal hernia follows the tract of inguinal canal and result from a persistent processus vaginalis.
Immediate pain after inguinal herniorrhaphy delays the ambulation which leads to delay in the hospital discharge. Besides that, is the chronic pain that affect 50% of patients which is an important issue that needs to be dealt with.
Our aim of this study, is to compare between postoperative period in the patients who received US guided nerve block and in patients who received infiltration only before open inguinal hernia repair, and to show that pre-emptive local anaesthesia will result in better pain control, less postoperative complication, earlier mobilisation, earlier recovery and less analgesia consumption by patients.
Detailed description
In this study our aim in detail is to:
- Asses the outcomes (early postoperative pain management in day case "day 1,2,3, 30 and 3 month and 6 month" , length of hospital stay, analgesia consumption، recovery to work, driving and usual activity) of the US guided nerve block in patients who underwent inguinal hernia repair comparing to patient who received only skin infiltration.
- Evaluate the advantages of the US guided nerve block in postoperative inguinal hernia repair patients.
- Demonstrate its compatibly as a one day procedure (less length of hospital stay), with earlier return to work and driving and recovery in general.
- Compare our result with other international studies result.
Study in details:
it is Randomised Control Trial, Double blinded (patients and recruiter), study will be conducted in King Fahd University Hospital, Khobar, Eastern Province, Saudi Arabia. It contains 2 Arms ,Two Parallel groups. The experimental group will receive US guided nerve block and the control group will receive usual infiltration. Lidocaine+ Marcaine will be used in both group with same concentration (1%+.25%). The random allocation will be done using simple random allocation with a help of the following software (random.org).
Will compare the two groups regarding, a questionary with visual analogue will be distributed and data will be collected by recruiters regarding pain scale, length of hospital stay, return to work, return to driving and usual activity, and analgesia consumption post operative, all in day 1,2,3,4,30,3 month and 6 month post operatives (details in outcome section).
We are expecting to have a reduction in pain score from severe to moderate, about 20% in experimental group, and reducing the length of hospital stay from 1-2 days to one day procedure. And reduction in consumption of Analgesia postoperative.
our sample size will be 134 with a power of 80% and an effect size of 0.5, will include all patients who will have inguinal hernia repair and meet our inclusion criteria, in period of 12-18 months starting after obtaining of IRB approval.
- Inclusion criteria:
- Patients who underwent elective inguinal hernia repair (will consider the hernia size).
- Age from 18-70.
- Their ASA score 1,2 or 3 (American Society of Anesthesia)
- Operation under general anaesthesia.
- Open inguinal hernia repair.
- Exclusion criteria:
- All emergency inguinal hernia repair and recurrent hernia.
- Children and pregnant women.
- Patients having regional anaesthesia. (Spinal/Local).
- Laparoscopic inguinal hernia.
Data Management and analysis plan:
- SPSS latest version will be used for data analysis.
- Summary statistic will be obtained as frequency, and percentage for qualitative data, and means, medians and standard deviations from continuous variables.
- Analysis will be done by epidemiologist and biostatistician.
Ethical Considerations:
- Our study does not have any physical, psychological, social, legal, economic risk.
- The study will be reviewed by IRB, ethics committee; then the approval will be obtained.
- Written approval will be obtained from the patients prior to the procedure.
- Preemptive analgesia and infiltration are usually used in our practice and aim to compare.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 2 Arms Arm1) The experimental group will receive US guided nerve block by Lidocaine+Marcaine concentration (1%+.25%). Arm2) The control group will receive usual infiltration by Lidocaine+Marcaine concentration (1%+.25%).
| Arm | Type | Receives |
|---|---|---|
| The experimental group will receive US guided nerve block | Experimental | Procedure: Ultra sound guided nerve blockThe experimental group will receive US guided nerve block by lidocaine before open inguinal hernia repair. |
| The control group will receive usual infiltration | Other | Procedure: Usual infiltrationThe control group will receive usual infiltration by lidocaine before open inguinal hernia repair. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
Key exclusion criteria (4 listed)
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 |
|---|---|---|
| Ultra sound guided nerve blockUltra sound guided nerve block by lidocaine before open inguinal hernia repair. | Procedure or surgery | The experimental group will receive US guided nerve block |
| Usual infiltrationUsual infiltration by lidocaine before open inguinal hernia repair. | Procedure or surgery | The control group will receive usual infiltration |
Primary outcome
Pain Scale (from 1 to 10) 1 is the minimum and 10 the maximum pain severity.
Time frame: Day 1 postoperative.
Assessment of pain scale post operative, lower score mean a better outcome.
Pain Scale (from 1 to 10) 1 is the minimum and 10 the maximum pain severity.
Time frame: Day 2 postoperative.
Assessment of pain scale post operative, lower score mean a better outcome.
Pain Scale (from 1 to 10) 1 is the minimum and 10 the maximum pain severity.
Time frame: Day 3 postoperative.
Assessment of pain scale post operative, lower score mean a better outcome.
Pain Scale (from 1 to 10) 1 is the minimum and 10 the maximum pain severity.
Time frame: Day 4 postoperative.
Assessment of pain scale post operative, lower score mean a better outcome.
Pain Scale (from 1 to 10) 1 is the minimum and 10 the maximum pain severity.
Time frame: Day 30 postoperative.
Assessment of pain scale post operative, lower score mean a better outcome.
Pain Scale (from 1 to 10) 1 is the minimum and 10 the maximum pain severity.
Time frame: 3 month postoperative for chronic pain.
Assessment of pain scale post operative, lower score mean a better outcome.
Pain Scale (from 1 to 10) 1 is the minimum and 10 the maximum pain severity.
Time frame: 6 month postoperative for chronic pain.
Assessment of pain scale post operative, lower score mean a better outcome.
Assessment of early mobilisation.
Time frame: Day 1 postoperative period.
When the patient started to mobilise? assessed by monitoring the patients postoperative and record when he started to mobilise.
Assessment of early mobilisation.
Time frame: Day 2 postoperative period.
When the patient started to mobilise? assessed by monitoring the patients postoperative and record when he started to mobilise.
Assessment of early mobilisation.
Time frame: Day 3 postoperative period.
When the patient started to mobilise? assessed by monitoring the patients postoperative and record when he started to mobilise.
Retain to driving (how many days between surgery and patient back to dive)
Time frame: Postoperative period up to 8 weeks.
When the patient back to drive his car? assessed by monitoring the patients postoperative and record when he started to drive the car again.
Retain to work (how many days between surgery and patient back to his work)
Time frame: Postoperative period up to 8 weeks.
When the patient back to his work or usual activity? assessed by monitoring the patients postoperative and record when he started to work again.
Length of hospital stay (in days).
Time frame: immediately after the surgery until patient discharged.
Length of hospital stay post open inguinal hernia repair ( how many days patient spend in the hospital postoperative).
Frequency of analgesia consumption postoperative.
Time frame: Day 1 postoperative.
Analgesia consumption by patient postoperative (How frequent patient taking analgesia postoperative).
Frequency of analgesia consumption postoperative.
Time frame: Day 2 postoperative.
Analgesia consumption by patient postoperative (How frequent patient taking analgesia postoperative).
Frequency of analgesia consumption postoperative.
Time frame: Day 3 postoperative.
Analgesia consumption by patient postoperative (How frequent patient taking analgesia postoperative).
Frequency of analgesia consumption postoperative.
Time frame: Day 4 postoperative.
Analgesia consumption by patient postoperative (How frequent patient taking analgesia postoperative).
Frequency of analgesia consumption postoperative.
Time frame: Day 5 postoperative.
Analgesia consumption by patient postoperative (How frequent patient taking analgesia postoperative).
Frequency of analgesia consumption postoperative.
Time frame: Day 6 postoperative.
Analgesia consumption by patient postoperative (How frequent patient taking analgesia postoperative).
Frequency of analgesia consumption postoperative.
Time frame: Day 7 postoperative.
Analgesia consumption by patient postoperative (How frequent patient taking analgesia postoperative).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2021.
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.
Questions about this trial
What is this clinical trial studying?
A study testing Ultra sound guided nerve block and Usual infiltration in people with Inguinal Hernia, run by Imam Abdulrahman Bin Faisal University.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 2 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nasser M Amer (00966 53 865 9290, nmamer@iau.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Scale (from 1 to 10) 1 is the minimum and 10 the maximum pain severity. (time frame: Day 1 postoperative.). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2021.