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

The University of The West Indies

Status and phase: Unknown; Phase 3

Conditions: Anesthesia, Local; Conscious Sedation; Inguinal Hernia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02444260

ECP342,12/13

Details and patient eligibility

About

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

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Reducible inguinal hernia

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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180 participants in 2 patient groups

Intravenous Normal Saline

Sham Comparator group

Description:

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

Treatment:

Drug: Lignocaine HCl

Drug: Bupivocaine

Drug: Intravenous Normal Saline

Midazolam

Active Comparator group

Description:

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.

Treatment:

Drug: Lignocaine HCl

Drug: Bupivocaine

Drug: Midazolam