None listed
Conditions
Brief summary
Despite the best efforts of medical practitioners, a short period of severe post-operative pain is still experienced by many patients undergoing surgery. This is particularly so in patients that undergo laparoscopic repair of a hiatus hernia, since there are limited pain relief options that do not cause nausea and vomiting (as these could ultimately lead to disruption of the surgical repair). Many studies have shown that intravenous lignocaine infusion in the perioperative period is safe and has clear advantages in patients undergoing abdominal surgery. These same studies concluded that further research is needed to determine the optimum dose, timing and duration of infusion of lignocaine in this setting. This study aims to evaluate the benefits and validate the safety of intravenous lignocaine for pain relief for patients undergoing laparoscopic repair of hiatus hernia.
Interventions
Patients will be randomised to receive lignocaine or placebo, to begin following the induction of anaesthesia. The treatment regimen is as follows:
1. Loading dose (lignocaine or placebo): 1mg/kg (0.1ml/kg) administered intravenously as a single dose at a rate of 20mg/minute (2ml/minute). Following completion of the loading dose, immediate commencement of;
2. Constant rate infusion (lignocaine or placebo): 2mg/kg/hr (0.2ml/kg/hr) for 24 hours.
Dose titration / adjustment will not be performed.
Patients will be randomised to receive lignocaine or placebo, to begin following the induction of anaesthesia. The treatment regimen is as follows: 1. Loading dose (lignocaine or placebo): 1mg/kg (0.1ml/kg) administered intravenously as a single dose at a rate of 20mg/minute (2ml/minute). Following completion of the loading dose, immediate commencement of; 2. Constant rate infusion (lignocaine or placebo): 2mg/kg/hr (0.2ml/kg/hr) for 24 hours. Dose titration / adjustment will not be performed. If adverse effects are seen, the infusion will be ceased. At the end of the treatment period, the study drug will be discontinued without tapering. Each participant's involvement in the trial will end when they are discharged from hospital.
Sponsors
Dr Stephanie Phillips
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female, aged 18 years or over; 2. Undergoing laparoscopic surgical repair of hiatus hernia by Prof Gregory Falk.
Exclusion criteria
1. Known allergies to local anaesthetics; 2. Chronic use of analgesics or corticosteroids; 3. Impaired hepatic function; 4. Epilepsy or other seizure disorder; 5. Severe cardiac failure or cardiac arrhythmias (e.g. supraventricular arrhythmias, Stokes-Adams syndrome, severe sinoatrial, atrioventricular or intraventicular block); 6. Pregnancy.
Outcome results
None listed