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

NCT03193723 | Completed

• 1 other identifier: UsHernia
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Inguinal Hernia

Keywords

Hernia; Local anesthesia; ultrasound

Outcome Measures

Primary Outcomes (1)

• NRS 4 hours postoperative

  Numerical Rating pain score 4 hours postoperative

  4 hours

Secondary Outcomes (8)

• NRS 30 minutes postoperative

  30 minutes

• NRS 12 hours postoperative

  12 hours

• Time of first rescue analgesic dose

  12 hours

• Total analgesic dose in the first 12 hours postoperative

  12 hours

• Incidence of Side effects

  12 hours

Study Arms (2)

Group A

ACTIVE COMPARATOR

US guided five step field block will be performed

Procedure: US guided five step field block

Group B

ACTIVE COMPARATOR

Spinal anesthesia will be administered in sitting position

Procedure: Spinal anesthesia

Interventions

US guided five step field block PROCEDURE

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

Group A

Spinal anesthesia PROCEDURE

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.

Group B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eslam Ayman Mohamed Shawki: lead

Study Sites (1)

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

Cairo, Egypt

Location

Related Publications (7)

• 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.

  PMID: 22211031 BACKGROUND

• 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.

  PMID: 22012289 BACKGROUND

• 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.

  PMID: 6729669 BACKGROUND

• 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.

  PMID: 19700776 BACKGROUND

• 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.

  PMID: 18428988 BACKGROUND

• 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.

  PMID: 19352161 BACKGROUND

• 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.

  PMID: 26895656 BACKGROUND

MeSH Terms

Conditions

Hernia, Inguinal; Hernia

Interventions

Anesthesia, Spinal

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Single blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer of anesthesia, SICU & Pain Management

Model Details: A Randomized Controlled study.

Study Record Dates

• First Submitted: June 19, 2017
• First Posted: June 21, 2017
• Study Start: October 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: August 1, 2018
• Last Updated: October 4, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)