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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.
In this study our aim in detail is to:
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:
Exclusion criteria:
Data Management and analysis plan:
Ethical Considerations:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| The control group will receive usual infiltration | Other | The control group will receive usual infiltration by lidocaine before open inguinal hernia repair. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultra sound guided nerve block | Procedure | Ultra sound guided nerve block by lidocaine before open inguinal hernia repair. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nasser M Amer | Contact | 00966 53 865 9290 | nmamer@iau.edu.sa |
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| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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%).
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Double blinded ( Patient and researcher recruiter)
| Usual infiltration | Procedure | Usual infiltration by lidocaine before open inguinal hernia repair. |
|
| 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. | 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. | 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. | 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. | 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. | 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). | immediately after the surgery until patient discharged. |
| Frequency of analgesia consumption postoperative. | Analgesia consumption by patient postoperative (How frequent patient taking analgesia postoperative). | Day 1 postoperative. |
| Frequency of analgesia consumption postoperative. | Analgesia consumption by patient postoperative (How frequent patient taking analgesia postoperative). | Day 2 postoperative. |
| Frequency of analgesia consumption postoperative. | Analgesia consumption by patient postoperative (How frequent patient taking analgesia postoperative). | Day 3 postoperative. |
| Frequency of analgesia consumption postoperative. | Analgesia consumption by patient postoperative (How frequent patient taking analgesia postoperative). | Day 4 postoperative. |
| Frequency of analgesia consumption postoperative. | Analgesia consumption by patient postoperative (How frequent patient taking analgesia postoperative). | Day 5 postoperative. |
| Frequency of analgesia consumption postoperative. | Analgesia consumption by patient postoperative (How frequent patient taking analgesia postoperative). | Day 6 postoperative. |
| Frequency of analgesia consumption postoperative. | Analgesia consumption by patient postoperative (How frequent patient taking analgesia postoperative). | Day 7 postoperative. |