None listed
Conditions
Brief summary
Our study hypothesis is that 20mL of bupivacaine 0.5% infiltrated via paracervical block after induction of general anaesthesia and prior to the initial surgical incision will improve patients’ quality of recovery at 24-36 hours following total laparoscopic hysterectomy.
Interventions
The intervention group will receive 20mL of bupivacaine 0.5% with 1:200,000 adrenaline infiltrated via paracervical block, after induction of general anaesthesia and prior to the initial surgical incision. The intervention is TGA approved.
Five millilitres of the solution will be injected at the 3, 5, 7, and 9 o’clock positions of the cervicovaginal junction at a depth of 10mm as described in the 7th edition of Te Linde’s Operative Gynecology.
The injection will be prepared at the hospital pha
The intervention group will receive 20mL of bupivacaine 0.5% with 1:200,000 adrenaline infiltrated via paracervical block, after induction of general anaesthesia and prior to the initial surgical incision. The intervention is TGA approved. Five millilitres of the solution will be injected at the 3, 5, 7, and 9 o’clock positions of the cervicovaginal junction at a depth of 10mm as described in the 7th edition of Te Linde’s Operative Gynecology. The injection will be prepared at the hospital pharmacy. The Study Coordinator will deliver this to the surgeon in theatre. A copy of the randomisation sheet documenting the drug administered will be filed in the patients medical records. The surgeon, patient and anaesthetist will not be aware of which preparation is used.
Sponsors
St John of God Subiaco Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Women undergoing a total laparoscopic hysterectomy (TLH) plus or mimus bilateral Salpingo-oophorectomy (BSO) for any of the following conditions: a. Heavy menstrual bleeding/ abnormal uterine bleeding b. Stage 1 and 2 Endometriosis c. Adenomyosis d. Risk reduction surgery e.g. carriers of BRCA1/2 gene faults, Lynch Syndrome or women considered high risk due to family history e. Complex adnexal masses not suspicious for malignancy f. Early stage cervical cancer requiring simple hysterectomy 2. Patients aged 18 years of age and over 3. Fluent in English
Exclusion criteria
1. Chronic pelvic pain 2. Recent opioid use (4 weeks prior to surgery) 3. Deeply infiltrative endometriosis (evidence of nodular disease on USS) or endometrioma. 4. Allergies to protocol drugs 5. Endometrial cancer 6. Patient requiring comprehensive surgical staging of malignant disease 7. Previous midline laparotomy 8. BMI >40kg/m2 9. Renal impairment (eGFR< 60 or Cr > 100) 10. Hepatic impairment (ALT> 40 or AST > 40) 11. Alcohol and drug dependency 12. Pregnancy
Outcome results
None listed