Post abdominal surgery pain MedDRA version: 9.1 Level: LLT Classification code 10054711 Term: Postoperative pain
Conditions
Interventions
Trade Name: lidocaine
Pharmaceutical Form: Solution for injection
INN or Proposed INN: LIDOCAINE
CAS Number: 137586
Concentration unit: % (W/V) percent weight/volume
Concentration type: up to
Concentr
Sponsors
Department of Anaesthesia, University College Hospital Galway
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: aged 18 - 40 healthy ASA 1-2 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Pregnancy Allergy to amide type local anaesthetic agents Infection / lesions at the site of injection renal or other organ dysfunction Sepsis Heart Block (complete or partial) Acidosis Advanced liver disease Refusal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The TAP block has been shown to be an effective approach to analgesia post abdominal surgery. However studies to date have focused on single shot techniques and as such the analgesic results are time limited. We plan to pass epidural like catheters into the TAP bilterally under ultrasound guidance in healthy volunteers. Once position has been confirmed both sides will be bolused with local anaesthetic agent - lidocaine. The dermatomal spread of paraesthesia will be monitored on both sides. On one side an infusion of local anaesthetic agent (lignocaine 1%) will be commenced at a standard perineural catheter rate. On the other side at set time intervals boli of local anaesthetic agent (lignocaine 1%) will be administered and again the dermatomal spread of paraesthesia monitored.;Secondary Objective: To determine if bolus or infusions provide better paraesthesia which relates to the provision of post-surgical analgesia;Primary end point(s): The primary end point is to monitor the dermatomal spread of paraesthesia following the injection of local anaesthetic agent (lidocaine 1%). We plan to investigate whether infusion of local anaesthetic agents provide denser, longer duration of action of paraesthesia than repeated boli. | — |
Countries
Ireland
Outcome results
None listed