RecruitingPhase 2ACTRN12621000584831

The effect of a paracervical block prior to total laparoscopic hysterectomy on patient's quality of recovery.

Paracervical local anaethesia to mitigate post operative pain after total laparoscopic hysterectomy: A single centered, randomised, double-blinded, placebo-controlled, phase II study comparing the use of the paracervical block versus placebo.

Sponsor

St John of God Subiaco Hospital

Enrollment

94 participants

Start Date

Sep 7, 2021

Study Type

Interventional

Conditions

Hysterectomy

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.

Eligibility

Sex: FemalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Laparoscopic (keyhole) hysterectomy is one of the most common gynaecological operations, but like all surgery it causes pain afterward. A paracervical block is a technique where local anaesthetic is injected around the cervix before the operation begins, which may reduce the pain signals from the uterus and potentially improve recovery. This study tests whether this simple add-on procedure, using bupivacaine anaesthetic, improves patients' overall quality of recovery in the 24 to 36 hours after surgery. You may be eligible if you are a woman aged 18 or older who is scheduled for a total laparoscopic hysterectomy (with or without removal of the ovaries) for conditions such as heavy bleeding, endometriosis, adenomyosis, high genetic risk (BRCA), or early-stage cervical cancer, at St John of God Subiaco Hospital. Women with chronic pelvic pain, recent opioid use, deeply infiltrative endometriosis, certain allergies, or severe kidney or liver problems are not eligible. Participants are randomly assigned to receive either the bupivacaine paracervical block or a sham injection, and neither the patient nor the surgeon knows which was given. Quality of recovery is assessed using a standardised questionnaire. The hope is that this inexpensive, safe intervention can meaningfully improve the surgical experience for women undergoing hysterectomy.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

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 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.