SUSTAIN For PAI

Not Applicable

Recruiting

• Conditions: Post-operative laparotomy patients; Anaesthesiology - Pain management

• Registration Number: ACTRN12610000246088
• Lead Sponsor: Western Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-24
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Patients age 18 years or over.
Elective or semi-elective surgery requiring a mid-line abdominal incision.
Planned intraoperative Transversus Abdominis Plane blocks and postoperative morphine patient controlled analgesia.

Exclusion Criteria

Plan for epidural and/or spinal analgesia.
Surgeon or anaesthetist refusal to placement of catheters.
Inability to communicate in English due to a language barrier, cognitive deficit or intellectual disability.
Inability of patient to use patient controlled analgesia (PCA) pump postoperatively or to understand visual analogue pain score.
Patients flagged for postoperative ventilation.
Asthma if exacerbated by non-steroidal anti-inflammatory drugs (NSAIDs) or asthma if a patient has never taken a NSAID.
Acute abdomen, with clinical signs of abdominal peritonism.
Septicaemia involving positive bacterial blood cultures.
Localised infection at the site of proposed needle insertion.
Opioid tolerant patients, i.e. any of the following:
-Patient taking an average of 8 Panadeine Forte tablets per day for a greater than one week.
-Patients taking greater than 40 mg oxycodone per day for greater than one week.
-Patients receiving 20 mg morphine parenterally per day for greater than one week.
-Patients on a fentanyl patch of dose greater than 12.5 mcg/hour for greater than one week.
-Any patient receiving buprenorphine.
-Any patient receiving methadone.
-Any patient receiving naltrexone or naloxone as part of an opioid abstinence program.
Any history of injected or inhaled illicit drug use in the previous six months.
A clinical history of chronic pain, where patients may benefit from early commencement of ketamine.
Renal impairment with creatinine clearance less than 60 mL/min.
Severe hepatic impairment (Child-Pugh score greater than or equal to 10).
Patients with unstable or uncontrolled epilepsy.
Allergy or contraindication to morphine, ropivacaine, tramadol, parocoxib, sulphonamides or paracetamol.
Patients on ketaconazole, fluconazole, monoamine oxidase inhibitors, selective serotonin reuptake inhibitors (SSRIs), serotonin noradradrenaline reuptake inhibitors (SNRIs), tricyclic anti-depressents, carbemazepine, quinidine, antipsychotics, zidovudine or warfarin.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint of the trial will be the ratio of total morphine administration between 24-48 hours postoperatively and 0-24 hours post-operatively.[48 hrs post-operatively.]