None listed
Conditions
Brief summary
The purpose of the TIPS study is to compare the effectiveness of two different interventions given before surgery to see if they improve the time needed to recover after surgery. The two interventions being tested are a ‘carboloading’ drink and pain medication called pregabalin (Lyrica ®). The study aim is to reduce the time needed to recover after surgery. Who is it for? You may be eligible for this study if you are an adult woman who will undergo an operation for ovarian cancer. Study details The study involves randomly allocating participants to two different interventions. Firstly, participants are randomised to receive a carbohydrate drink (Nutricia PreOp Drink), water or no drink before surgery. The drink is to be taken 2 hours before the operation. Secondly, participants are randomised to receive pain medication capsule (pregabalin) or a placebo capsule. The capsule is given by mouth 1 hour before the operation and 12 hours after the first dose. Following routine surgery participants will have to complete some questionnaires and answer some questions about how they're feeling, once discharged from hospital the study team will call them 30 days after discharge to ask some questions about their recovery. It is hoped that the findings from this study may improve women having surgery for ovarian cancers comfort prior to an operation and reducing pain after the operation.
Interventions
This study involves randomly allocating participant into one of three study groups for the drink (intervention 1) and into one of two study groups for the pain medication capsule (intervention 2) as follows:
Intervention 1:
Drink 1: Carbo-loading drink (400 ml, 50g carbohydrate) to be consumed within 5-10 minutes, 2 hours before the operation
Drink 2: Water (400ml, 0g carbohydrates) to be consumed within 5-10 minutes, 2 hours before the operation
Drink 3: No drink (0ml, 0g carbohydrates).
Inte
This study involves randomly allocating participant into one of three study groups for the drink (intervention 1) and into one of two study groups for the pain medication capsule (intervention 2) as follows: Intervention 1: Drink 1: Carbo-loading drink (400 ml, 50g carbohydrate) to be consumed within 5-10 minutes, 2 hours before the operation Drink 2: Water (400ml, 0g carbohydrates) to be consumed within 5-10 minutes, 2 hours before the operation Drink 3: No drink (0ml, 0g carbohydrates). Intervention 2: Capsule 1: 75 mg pregabalin capsule 1 hour before the operation and about 12 hours after the first capsule Capsule 2: Placebo capsule 1 hour before the operation and about 12 hours after the first capsule. A placebo is a medication with no active ingredients that is identical in appearance to the active medication.
Sponsors
University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Factorial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Women aged 18 and older with suspected advanced malignancy of the ovary/fallopian tube or peritoneum. 2. Disease suspected to be at least Stage III disease at initial diagnosis. 3. Planned to undergo laparotomy (primary surgery or after neoadjuvant chemotherapy of a maximum 4 cycles of chemotherapy). 4. Adequate renal function (e.g. creatinine clearance greater than 50 ml/min). 5. Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments. 6. Signed, written informed consent.
Exclusion criteria
1. History of uncontrolled insulin-dependent diabetes mellitus. 2. Uncontrolled gastro-oesophageal reflux disease or disorders of gastric emptying. 3. Intestinal obstruction 4. Known allergy to pregabalin or to any ingredients of the Nutricia pre-op drink. 5. Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol. 6. Pregnant or lactating.
Outcome results
None listed