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

October 2, 2018 updated by: Eslam Ayman Mohamed Shawki

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Faculty of medicine, Cairo University teaching hospitals (Kasr Alainy)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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):

  • 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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NRS 4 hours postoperative
Time Frame: 4 hours
Numerical Rating pain score 4 hours postoperative
4 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NRS 30 minutes postoperative
Time Frame: 30 minutes
Numerical Rating pain score 30 minutes postoperative.
30 minutes
NRS 12 hours postoperative
Time Frame: 12 hours
Numerical Rating pain score 12 hours postoperative.
12 hours
Time of first rescue analgesic dose
Time Frame: 12 hours
The time of request for the first rescue dose of analgesic medication
12 hours
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
12 hours
Incidence of Side effects
Time Frame: 12 hours
Complications including nausea, vomiting, wound hematoma, hypotension, persistent headache and urinary retention
12 hours
Time for ambulation
Time Frame: 12 hours
The time needed to start pain free unassisted ambulation and the duration of hospital stay.
12 hours
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.)
12 hours
Intra operative surgeon satisfaction
Time Frame: 12 hours
Intra operative surgeon satisfaction with the type of anesthesia (satisfied or not)
12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eslam Ayman Mohamed Shawki

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

June 19, 2017

First Submitted That Met QC Criteria

June 20, 2017

First Posted (Actual)

June 21, 2017

Study Record Updates

Last Update Posted (Actual)

October 4, 2018

Last Update Submitted That Met QC Criteria

October 2, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UsHernia

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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