A Trial of Local Anaesthesia Versus Local Anaesthesia and Conscious Sedation for Hernioplasty

NCT02444260 | Unknown Phase 3 DMC

• 1 other identifier: ECP342,12/13
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this RCT is to compare patient outcomes of inguinal hernioplasty under Local Anaesthesia alone versus Local Anaesthesia and Conscious Sedation Specific study objectives are to determine the effect of conscious sedation on: (i) patient satisfaction (ii) postoperative pain (iii) time to discharge (iv) intraoperative complications (v) postoperative functional status (vi) short-term postoperative complications (vii) long-term postoperative complications

Conditions

Inguinal Hernia; Anesthesia, Local; Conscious Sedation

Keywords

Inguinal Hernia,; Local Anesthesia; Randomized Clinical trial; HERNIOPLASTY

Outcome Measures

Primary Outcomes (1)

• patient satisfaction as assessed with the Iowa Satisfaction with Anesthesia Scale

  Change in the Iowa Satisfaction with Anesthesia Scale from baseline (pre-discharge assessment)

  1 year

Secondary Outcomes (5)

• Operative time

  2 weeks

• Frequency (total count) of postoperative complications using a questionaire

  1 year

• Post-operative assessment of physical activity using Activities Assessment Scale

  1 year

• Time to discharge

  2 weeks

• change in postoperative pain score from baseline assessed with visual analog scale

  1 year

Study Arms (2)

Intravenous Normal Saline

SHAM COMPARATOR

Intravenous Normal Saline plus Lignocaine HCl (1%) - administered by wound infiltration to a maximum dose of 4.5mg/kg ; Bupivocaine HCl (0.25%) - administered by wound infiltration to a maximum dose of 2 mg/kg plus i

Drug: Intravenous Normal Saline; Drug: Bupivocaine; Drug: Lignocaine HCl

Midazolam

ACTIVE COMPARATOR

Lignocaine HCl (1%) - administered by wound infiltration to a maximum dose of 4.5mg/kg Bupivocaine HCl (0.25%) - administered by wound infiltration to a maximum dose of 2 mg/kg plus Midazolam - administered intravenously. 1 mg given stat. Titrated by 1 mg to a maximum dose of 10 mg.

Drug: Midazolam; Drug: Bupivocaine; Drug: Lignocaine HCl

Interventions

Midazolam DRUG

Midazolam will administered intravenously. 1 mg given stat. Titrated by 1 mg to a maximum dose of 10 mg. Additional sedation will be given to achieve and maintain a score of 2-3 on the Ramsay sedation scale during the procedure, up to the maximum dose of 10mg.

Also known as: Dormicum

Midazolam

Intravenous Normal Saline DRUG

Intravenous normal saline will be infused by non-blinded anaesthetist

Also known as: 0.9% sodium chloride solution

Intravenous Normal Saline

Bupivocaine DRUG

Bupivcaine 0.25% solution administered by wound infiltration to a maximum dose of 2 mg/kg

Also known as: Marcaine

Intravenous Normal Saline; Midazolam

Lignocaine HCl DRUG

Lignocaine !% solution administered by wound infiltration to a maximum dose of 4.5mg/kg

Also known as: xylocaine

Intravenous Normal Saline; Midazolam

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Reducible inguinal hernia

You may not qualify if:

• Renal, hepatic, respiratory, cardiovascular, neurologic or psychiatric disease
• Body mass index \< 18.5 kg/m2 or \> 30 kg/m2
• Recurrent inguinal hernias
• Bilateral inguinal hernias
• Large inguinoscrotal hernias
• Incarcerated hernia
• Allergies to local anaesthetic and sedative agents
• Pregnancy
• Lactation
• Chronic pain syndromes
• Anxiety disorders
• Marijuana use
• Long term use of opioid or sedative agents

Sponsors & Collaborators

• The University of The West Indies: lead

Study Sites (1)

University of the West Indies, mona

Kingston, Please Select, Jamaica

RECRUITING

Related Publications (1)

• Leake PA, Toppin PJ, Reid M, Plummer JM, Roberts PO, Harding-Goldson H, McFarlane ME. Local Anesthesia Versus Local Anesthesia and Conscious Sedation for Inguinal Hernioplasty: Protocol of a Randomized Controlled Trial. JMIR Res Protoc. 2017 Feb 7;6(2):e20. doi: 10.2196/resprot.6754.

  PMID: 28174148 DERIVED

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

Midazolam; Sodium Chloride; Bupivacaine; Lidocaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Acetanilides

Central Study Contacts

Pierre Leake, DM

CONTACT

Pierre-Anthony Leake <paeleake@yahoo.com>

Marvin Reid, PhD

CONTACT

marvin.reid@uwimona.edu.jm

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2015
• First Posted: May 14, 2015
• Study Start: December 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2016
• Last Updated: May 14, 2015

Record last verified: 2015-03

Locations

JA (1)