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

Primary Purpose

Inguinal Hernia

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
US guided five step field block
Spinal anesthesia
Sponsored by
Eslam Ayman Mohamed Shawki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inguinal Hernia focused on measuring Hernia, Local anesthesia, ultrasound

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group A

Group B

Arm Description

US guided five step field block will be performed

Spinal anesthesia will be administered in sitting position

Outcomes

Primary Outcome Measures

NRS 4 hours postoperative
Numerical Rating pain score 4 hours postoperative

Secondary Outcome Measures

NRS 30 minutes postoperative
Numerical Rating pain score 30 minutes postoperative.
NRS 12 hours postoperative
Numerical Rating pain score 12 hours postoperative.
Time of first rescue analgesic dose
The time of request for the first rescue dose of analgesic medication
Total analgesic dose in the first 12 hours postoperative
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
Complications including nausea, vomiting, wound hematoma, hypotension, persistent headache and urinary retention
Time for ambulation
The time needed to start pain free unassisted ambulation and the duration of hospital stay.
Intra operative patient satisfaction
Intra operative patient satisfaction (rated as 1 to be very satisfied, 2 moderately satisfied and 3 poorly satisfied.)
Intra operative surgeon satisfaction
Intra operative surgeon satisfaction with the type of anesthesia (satisfied or not)

Full Information

First Posted
June 19, 2017
Last Updated
October 2, 2018
Sponsor
Eslam Ayman Mohamed Shawki
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1. Study Identification

Unique Protocol Identification Number
NCT03193723
Brief Title
Ultrasound Guided Local Anesthetic Field Block (A Five Step Procedure) for Open Inguinal Hernia Repair
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
October 1, 2016 (Actual)
Primary Completion Date
July 1, 2018 (Actual)
Study Completion Date
August 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Eslam Ayman Mohamed Shawki

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia
Keywords
Hernia, Local anesthesia, ultrasound

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A Randomized Controlled study.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Single blinded
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Description
US guided five step field block will be performed
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Spinal anesthesia will be administered in sitting position
Intervention Type
Procedure
Intervention Name(s)
US guided five step field block
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Spinal anesthesia
Intervention Description
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.
Primary Outcome Measure Information:
Title
NRS 4 hours postoperative
Description
Numerical Rating pain score 4 hours postoperative
Time Frame
4 hours
Secondary Outcome Measure Information:
Title
NRS 30 minutes postoperative
Description
Numerical Rating pain score 30 minutes postoperative.
Time Frame
30 minutes
Title
NRS 12 hours postoperative
Description
Numerical Rating pain score 12 hours postoperative.
Time Frame
12 hours
Title
Time of first rescue analgesic dose
Description
The time of request for the first rescue dose of analgesic medication
Time Frame
12 hours
Title
Total analgesic dose in the first 12 hours postoperative
Description
The total doses of analgesics needed (whether opioids or non-opioids) to maintain an NRS score < 3 over the first 12 hours post-operative
Time Frame
12 hours
Title
Incidence of Side effects
Description
Complications including nausea, vomiting, wound hematoma, hypotension, persistent headache and urinary retention
Time Frame
12 hours
Title
Time for ambulation
Description
The time needed to start pain free unassisted ambulation and the duration of hospital stay.
Time Frame
12 hours
Title
Intra operative patient satisfaction
Description
Intra operative patient satisfaction (rated as 1 to be very satisfied, 2 moderately satisfied and 3 poorly satisfied.)
Time Frame
12 hours
Title
Intra operative surgeon satisfaction
Description
Intra operative surgeon satisfaction with the type of anesthesia (satisfied or not)
Time Frame
12 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Faculty of medicine, Cairo University teaching hospitals (Kasr Alainy)
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22211031
Citation
Anand A, Sinha PA, Kittappa K, Mulchandani MH, Debrah S, Brookstein R. Review of Inguinal Hernia Repairs by Various Surgical Techniques in a District General Hospital in the UK. Indian J Surg. 2011 Jan;73(1):13-8. doi: 10.1007/s12262-010-0156-7. Epub 2011 Jan 8.
Results Reference
background
PubMed Identifier
22012289
Citation
Santos Gde C, Braga GM, Queiroz FL, Navarro TP, Gomez RS. Assessment of postoperative pain and hospital discharge after inguinal and iliohypogastric nerve block for inguinal hernia repair under spinal anesthesia: a prospective study. Rev Assoc Med Bras (1992). 2011 Sep-Oct;57(5):545-9. doi: 10.1590/s0104-42302011000500013. English, Portuguese.
Results Reference
background
PubMed Identifier
6729669
Citation
Flanagan L Jr, Bascom JU. Repair of the groin hernia. Outpatient approach with local anesthesia. Surg Clin North Am. 1984 Apr;64(2):257-67. doi: 10.1016/s0039-6109(16)43283-4.
Results Reference
background
PubMed Identifier
19700776
Citation
Belavy D, Cowlishaw PJ, Howes M, Phillips F. Ultrasound-guided transversus abdominis plane block for analgesia after Caesarean delivery. Br J Anaesth. 2009 Nov;103(5):726-30. doi: 10.1093/bja/aep235. Epub 2009 Aug 22.
Results Reference
background
PubMed Identifier
18428988
Citation
Rozen WM, Tran TM, Ashton MW, Barrington MJ, Ivanusic JJ, Taylor GI. Refining the course of the thoracolumbar nerves: a new understanding of the innervation of the anterior abdominal wall. Clin Anat. 2008 May;21(4):325-33. doi: 10.1002/ca.20621.
Results Reference
background
PubMed Identifier
19352161
Citation
Chanthong P, Abrishami A, Wong J, Herrera F, Chung F. Systematic review of questionnaires measuring patient satisfaction in ambulatory anesthesia. Anesthesiology. 2009 May;110(5):1061-7. doi: 10.1097/ALN.0b013e31819db079.
Results Reference
background
PubMed Identifier
26895656
Citation
Prakash D, Heskin L, Doherty S, Galvin R. Local anaesthesia versus spinal anaesthesia in inguinal hernia repair: A systematic review and meta-analysis. Surgeon. 2017 Feb;15(1):47-57. doi: 10.1016/j.surge.2016.01.001. Epub 2016 Feb 16.
Results Reference
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Ultrasound Guided Local Anesthetic Field Block (A Five Step Procedure) for Open Inguinal Hernia Repair

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