Ultrasound Guided Local Anesthetic Field Block (A Five Step Procedure) for Open Inguinal Hernia Repair
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|ClinicalTrials.gov Identifier: NCT03193723|
Recruitment Status : Completed
First Posted : June 21, 2017
Last Update Posted : October 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Inguinal Hernia||Procedure: US guided five step field block Procedure: Spinal anesthesia||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||96 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||A Randomized Controlled study.|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Masking Description:||Single blinded|
|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.|
|Actual Study Start Date :||October 1, 2016|
|Actual Primary Completion Date :||July 1, 2018|
|Actual Study Completion Date :||August 1, 2018|
Active Comparator: Group A
US guided five step field block will be performed
Procedure: US guided five step field block
Ultrasound will guide needle insertion in the following layers (except intradermic injection):
Active Comparator: Group B
Spinal anesthesia will be administered in sitting position
Procedure: Spinal anesthesia
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.
- NRS 4 hours postoperative [ Time Frame: 4 hours ]Numerical Rating pain score 4 hours postoperative
- NRS 30 minutes postoperative [ Time Frame: 30 minutes ]Numerical Rating pain score 30 minutes postoperative.
- NRS 12 hours postoperative [ Time Frame: 12 hours ]Numerical Rating pain score 12 hours postoperative.
- Time of first rescue analgesic dose [ Time Frame: 12 hours ]The time of request for the first rescue dose of analgesic medication
- Total analgesic dose in the first 12 hours postoperative [ Time Frame: 12 hours ]The total doses of analgesics needed (whether opioids or non-opioids) to maintain an NRS score < 3 over the first 12 hours post-operative
- Incidence of Side effects [ Time Frame: 12 hours ]Complications including nausea, vomiting, wound hematoma, hypotension, persistent headache and urinary retention
- Time for ambulation [ Time Frame: 12 hours ]The time needed to start pain free unassisted ambulation and the duration of hospital stay.
- Intra operative patient satisfaction [ Time Frame: 12 hours ]Intra operative patient satisfaction (rated as 1 to be very satisfied, 2 moderately satisfied and 3 poorly satisfied.)
- Intra operative surgeon satisfaction [ Time Frame: 12 hours ]Intra operative surgeon satisfaction with the type of anesthesia (satisfied or not)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03193723
|Faculty of medicine, Cairo University teaching hospitals (Kasr Alainy)|