None listed
Conditions
Brief summary
We propose a study which is first of its kind in Australia/New Zealand with an aim to objectively assess the role of performing a paracervical block in reducing postoperative pain and enhancing post-operative recovery following benign indicated laparoscopic hysterectomy. Paracervical block with 0.5% Bupivacaine (with adrenaline) has been previously tested as a potential strategy to optimise post-operative pain management following total laparoscopic hysterectomies (TLH). However, data in this regards remains scarce. Our proposed study aims to conduct objective evaluation of pain by measuring opioid intake post-operatively as well as by determining the impact of paracervical block in patient reported pain beyond the first 24 hours postextubation. In addition, we also attempt to determine subsequent impact on return to normal activity. The proposed study is a two-arm single centre double blinded randomized placebo-controlled trial. We believe this study will not only add to the current body of limited evidence but will also assist in planning and implementation of methods to improve perioperative pain management, maximise enhance recovery after surgery, and increase patient satisfaction. The potential overall impact in cost efficacy and economic gain is also worth consideration. Drug used in trial: The medication that we will examine and use in ‘treatment’ group is 0.5% Bupivacaine with Adrenaline. This is a TGA approved drug, with a well-established safety profile, frequently used in a number of gynecological procedures, and readily available in the institution where the trial will be carried out.
Interventions
Paracervical block with 0.5% Bupivacaine (with 1:200,000 Adrenaline) before benign laparoscopic hysterectomy
The study will objectively evaluate pain by measuring opioid intake postoperatively and by determining the impact in patient reported pain beyond the first 24 hours postextubation. Subsequent impact on return to normal activity and quality of life score (QOL) will also be determined using the widely validated tool EQ-5D 5L.
Two-arm single centre double blinded randomized placebo-contro
Paracervical block with 0.5% Bupivacaine (with 1:200,000 Adrenaline) before benign laparoscopic hysterectomy The study will objectively evaluate pain by measuring opioid intake postoperatively and by determining the impact in patient reported pain beyond the first 24 hours postextubation. Subsequent impact on return to normal activity and quality of life score (QOL) will also be determined using the widely validated tool EQ-5D 5L. Two-arm single centre double blinded randomized placebo-controlled trial. 1. Treatment arm: Paracervical injection of 0.5% bupivacaine with adrenaline 1:200,000 (20 mL) containing 100mg of anhydrous bupivacaine HCL and 100 micrograms of adrenaline. 2. Placebo arm: Paracervical injection of normal saline (20 mL) Cervical infiltration technique: Infiltration will be performed just prior the insertion of uterine manipulator by the primary surgeon. The content will be injected into the cervical stroma at the 3 and 9 o’clock positions with a depth of 2-3 cm, with 10 mL injected at each side. Data will be routinely reviewed for completeness and accuracy as well as any evidence that may be indicative of participant risk. When the data are incomplete, attempts will be made to obtain the data whenever possible. Ensuring satisfactory response rate, data completeness and identifying missing data will remain responsibilities of the core research team. Every reasonable attempt will be made to determine the reason for a patient being lost to follow-up. All participants will be given a standardised discharge prescription of twenty tablets of 5 mg Oxycodone for use as ‘PRN’.
Sponsors
Tarana Lucky
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
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. Age greater than or equal to 18 years 2. Undergoing a total laparoscopic hysterectomy for benign indications (elective) 3. Indication of prophylactic surgery for at-risk patients can be included 4. With or without the following concurrent procedures: a. Unilateral or bilateral salpingo-oophorectomy b. Excision of endometriosis (below pelvic brim)
Exclusion criteria
1. Allergy to either of Bupivacaine, Adrenaline, or any amide anaesthetics or opioids 2. Any other contraindications to Adrenaline or Bupivacaine 3. Weight <50kg or >100kg 4. Emergency hysterectomy 5. For non-English speaking participants: Unable to collect data adequately despite use of language interpreter 6. Excision of endometriosis that is above pelvic brim 7. Concurrent bowel or upper abdominal surgery 8. Chronic pain requiring ongoing opioid analgesia 9. Any indication of malignancy pre-op 10. Any intra-op suspicion/detection of malignancy requiring lymph node dissection 11. Any concomitant vaginal procedures (prolapse repair, mid-urethral slings, etc.) 12. Intraoperative conversion to laparotomy 13. Inability to perform the paracervical block due to anatomic abnormalities 14. Intraoperative injury to gastrointestinal or urologic tract that necessitated repair 15. Patient needing return to OT for complications 16. Procedures requiring extensive additional tissue manipulation such as: a. Pelvic lymph node dissection b. Laparoscopic pelvic floor repair procedures
Outcome results
None listed