Postoperative pain MedDRA version: 9.1 Level: LLT Classification code 10054711 Term: Postoperative pain
Conditions
Interventions
Trade Name: Naropin
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ROPIVACAINE
CAS Number: 84057954
Current Sponsor code: TAP5
Other descriptive name: Local anaesthetic
Concentration
Sponsors
Dept of Anaesthesia, University College Hospital, Galway
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ASA 1-3 Age 18 - 85 years of age Patients scheduled for abdominal surgery Written Informed Consent 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patient refusal Outside Age Range Allergy to bupivacaine, Ropivacaine morphine, paracetamol, diclofenac sodium Skin lesions/infection at site of injection Renal or other organ dysfunction Sepsis Patients with partial or complete heart block Advanced Liver disease Acidosis or reduced plasma proteins Note: The above mentioned exclusion criteria exceeds criteria mentioned in section 4.4 of the SPC
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Our recent work has proven that the Transversus Abdominis Plane (TAP) Block is a safe and an effective analgesic regime for the treatment of post laparotomy pain. However the studies to date have used a single shot technique to achieve analgesic control. We feel that increasing the length of blockade of the anterior abdominal wall blockade will increase patient analgesia and therefore comfort. In this study we would like to compare the analgesic effects of the TAP block with catheter placement against standardised morphine based analgesia for unilateral abdominal surgery. We plan to show statistical significance in the analgesia between the two approaches.;Secondary Objective: Poorly controlled analgesia is associated with prolongation of hospital stay, and increased morbidity. The use of nerve blocks is a well established approach to postoperative analgesia. We plan to show that patients that received the TAP plus catheter approach had lower pain scores, mobilised earlier and in more comfort, and had shorter hospital stay. In the long term this approach may be used to facilitate day case surgery for minor abdominal surgery. The use of opioids is associated with side effects such as nausea, vomiting, pruritis and sedation, we plan to show a statistically significant difference in these side effects in the two patient groups by demonstrating a significant difference in morphine requirements ;Primary end point(s): Primary measures: Severity of postoperative pain (VAS scores and categorical pain scores) Total opiate usage in the first 72 hours Time to first request for morphine Secondary measures: sedation postoperative nausea and vomiting patient satisfaction | — |
Countries
Ireland
Outcome results
None listed