None listed
Conditions
Brief summary
This study will investigate the quality of post surgical pain relief in patients who have undergone major gynaecological cancer surgery. Who is it for? You may be eligible to join this study if you are a woman aged 18 years or above, who is undergoing a laparotomy for gynaecological cancer procedures. Trial details Participants in this trial will be randomly (by chance) allocated to have their catheter inserted into one of three positions on the abdomen (i.e. abdominis plane, rectus sheath plane, or subcutaneous plane) at the end of their surgery whilst under general anaesthesia. The catheter is used to deliver pain-reducing medication and will remain in place for 48-72 hours post surgery. The total morphine consumption, pain, nausea and patient satisfaction will be compared amongst the three groups at 24 and 48 hours post surgery. It is hoped that the study will show that the patients who receive the rectus sheath block and transversus abdominis block will have more effective pain relief and require less morphine compared with the subcutaneous catheter group. Less morphine should reduce side effects and improve patient satisfaction.
Interventions
Participants are randomised to receive either a catheter inserted in to transversus abdominis plane, rectus sheath plane or subcutaneous plane. All procedures will be performed at the end of the operation whilst under general anaesthesia by one of the investigators. During surgery participants will receive prophylactic antiemetics (Metoclopramide 20mg and Tropisetron 2mg intravenously) and a single dose of Parecoxib 40mg intravenously (unless contraindicated). All groups for a duration og 48 hou
Participants are randomised to receive either a catheter inserted in to transversus abdominis plane, rectus sheath plane or subcutaneous plane. All procedures will be performed at the end of the operation whilst under general anaesthesia by one of the investigators. During surgery participants will receive prophylactic antiemetics (Metoclopramide 20mg and Tropisetron 2mg intravenously) and a single dose of Parecoxib 40mg intravenously (unless contraindicated). All groups for a duration og 48 hours post surgery will receive 18ml boluses of 0.5% ropivacaine every 4 hours via a Y catheter (9 mls each side) at a total of 540 mg/day . The participants will be studied for 48 hours and the catheter will remain in situ for this time. The catheters will be removed on the third post operative day (48-72 hours post surgery). In addition for the first 48 hours post surgery patients will receive pain relief in the form of a morphine PCA and regular paracetamol. Intravenous antiemetics will be administered as required.
Sponsors
Mater Health Services
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Women who are undergoing a laparotomy for gynaecological oncology procedures with an expected midline incision.
Exclusion criteria
Conditions associated with opioid tolerance: regular opioid analgesia use in the last three months, previous IVDU Abdominal wall block technically difficult to perform: eg obesity (BMI > 35) Contraindication to abdominal wall block: local sepsis, local anaesthetic allergy, abnormal anatomy (for example nephrectomy scars) Preference for other technique for postoperative analgesia, such as epidural infusion. Presence of stoma Age less than 18. Inadequate capacity to consent
Outcome results
None listed