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Ultrasound Guided Local Anesthetic Field Block (A Five Step Procedure) for Open Inguinal Hernia Repair

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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03193723
Enrollment
96
Registered
2017-06-21
Start date
2016-10-01
Completion date
2018-08-01
Last updated
2018-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inguinal Hernia

Keywords

Hernia, Local anesthesia, ultrasound

Brief 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 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.

Interventions

PROCEDUREUS guided five step field block

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

PROCEDURESpinal 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.

Sponsors

Eslam Ayman Mohamed Shawki
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

Single blinded

Intervention model description

A Randomized Controlled study.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* ASA score I, II or Ш. * Patients with unilateral inguinal hernia for elective open mesh repair hernioplasty operation.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
NRS 4 hours postoperative4 hoursNumerical Rating pain score 4 hours postoperative

Secondary

MeasureTime frameDescription
NRS 12 hours postoperative12 hoursNumerical Rating pain score 12 hours postoperative.
Time of first rescue analgesic dose12 hoursThe time of request for the first rescue dose of analgesic medication
Total analgesic dose in the first 12 hours postoperative12 hoursThe total doses of analgesics needed (whether opioids or non-opioids) to maintain an NRS score \< 3 over the first 12 hours post-operative
NRS 30 minutes postoperative30 minutesNumerical Rating pain score 30 minutes postoperative.
Time for ambulation12 hoursThe time needed to start pain free unassisted ambulation and the duration of hospital stay.
Intra operative patient satisfaction12 hoursIntra operative patient satisfaction (rated as 1 to be very satisfied, 2 moderately satisfied and 3 poorly satisfied.)
Intra operative surgeon satisfaction12 hoursIntra operative surgeon satisfaction with the type of anesthesia (satisfied or not)
Incidence of Side effects12 hoursComplications including nausea, vomiting, wound hematoma, hypotension, persistent headache and urinary retention

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026