Para-cervical Block Prior to Laparoscopic Hysterectomy as an Adjuvant Treatment to Reduce Postoperative Pain.
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Bupivacaine; 0.9% Sodium Chloride
Intervention description: Inject 10 mL of 0.5% bupivacaine into cervical stroma; Inject 10 mL of 0.9% NaCl into cervical stroma
Intervention MeSH terms: Bupivacaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 41.0
Sex: Female
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: para-cervical block; laparoscopic hysterectomy

Summary:

      This is a prospective randomized controlled trial in which patients that are scheduled to
      undergo a laparoscopic hysterectomy would be allocated to one of two groups: Paracervical
      block with local anesthetic (bupivacaine 0.5%), or placebo. This would be achieved using
      block randomization. The intervention would be performed after the patient is under general
      anesthesia, prior to starting the surgery. Patients would be consented in the office or
      preoperative area (before receiving sedatives). As far as the intervention itself, it would
      consist of injecting 5 mL of 0.5% bupivacaine into the cervical stroma at 3 and 9 o'clock,
      which is standard technique for para-cervical block. The remainder of the procedure will then
      continue in a regular fashion. Alternatively, patients in the control group will be injected
      with 5 mL of normal saline. The surgeon would be blinded as to patient allocation. Research
      staff will have previously prepared the formulations (saline or bupivacaine) and have sent
      them to the operating room prior to beginning the procedure depending on assigned group. At
      the end of the case, pain will be assessed using a visual analogue scale with a range from 0
      to 10 by one of the researches who will also be blinded to the group. This will be done at 30
      and 60 minutes after surgical stop time. Additional pain control in the postanesthesia care
      unit (PACU) will be standardized to all patients.

      Hypothesis:

      Performing a para-cervical block with local anesthetic prior to a laparoscopic hysterectomy
      significantly reduces pain after the procedure
    

Eligibility criteria:

        Inclusion Criteria:

          -  Undergoing laparoscopic hysterectomy with or without salpingoophorectomy for benign
             indications

          -  Undergoing laparoscopic hysterectomy with robotic assistance with or without
             salpingoophorectomy for benign indications

          -  Between 18 and 60 years of age

        Exclusion Criteria:

          -  Intraoperative detection of malignancy

          -  Undergoing additional procedures at the time of surgery (except prophylactic McCall
             culdoplasty/uterosacral ligament suspension, excision of endometriosis, appendectomy,
             cystoscopy)

          -  Inability to perform paracervical block due to anatomic abnormalities (absent/flush
             cervix)

          -  Known allergy/sensitivity to bupivacaine

          -  Intraoperative bowel injury, bladder injury, ureter injury or major vessel injury that
             required repair.