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

NCT02444260 — Phase 3, Unknown, 180 participants, The University of The West Indies

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Improving Patient Outcomes With Inguinal Hernioplasty - a Randomized Controlled Trial of Local Anaesthesia Versus Local Anaesthesia and Conscious Sedation

Registry	NCT02444260
Status	Unknown
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: triple, treatment
Enrollment	180 (Estimated)
Sponsor	The University of The West Indies (Other)
Conditions	Inguinal Hernia, Anesthesia, Local, Conscious Sedation
Interventions	Midazolam, Intravenous Normal Saline, Bupivocaine, Lignocaine HCl (Drug)
Dates	start 2013-12-01, primary completion 2015-12-01 (estimated), completion 2016-12-01 (estimated), first posted 2015-05-14, last updated 2015-05-14
Locations	1 site in Jamaica

-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

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Intravenous Normal Saline	Sham comparator	Drug: Intravenous Normal Saline; Drug: Bupivocaine; Drug: Lignocaine HCl	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
Midazolam	Active comparator	Drug: Midazolam; Drug: Bupivocaine; Drug: Lignocaine HCl	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.

Midazolam (Drug), also known as Dormicum: 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.
Intravenous Normal Saline (Drug), also known as 0.9% sodium chloride solution: Intravenous normal saline will be infused by non-blinded anaesthetist
Bupivocaine (Drug), also known as Marcaine: Bupivcaine 0.25% solution administered by wound infiltration to a maximum dose of 2 mg/kg
Lignocaine HCl (Drug), also known as xylocaine: Lignocaine !% solution administered by wound infiltration to a maximum dose of 4.5mg/kg

+Outcome measures

Primary outcomes

patient satisfaction as assessed with the Iowa Satisfaction with Anesthesia Scale [1 year]: Change in the Iowa Satisfaction with Anesthesia Scale from baseline (pre-discharge assessment)

Secondary outcomes

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]: change in postoperative pain from baseline (pre-discharge assessment) assessed with visual analog scale

+Eligibility

Sex: All, ages: 18 Years to 75 Years

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

+Locations (1)

Facility	City	Country	Status
University of the West Indies, mona	Kingston, Please Select	Jamaica	Recruiting

+Publications

Results publication: 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