Para-cervical Block Prior to Laparoscopic Hysterectomy as an Adjuvant Treatment to Reduce Postoperative Pain.

Completed · Phase 3

Conditions studied: Pain, Postoperative

In brief

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

Key facts

Study ID

NCT03027661

Run by

University of Tennessee

People needed

41

Starts

2017-08-01

Expected to finish

2018-06-30

Last updated by the study team

2018-11-15

Who can join

Age: 18 and older, up to 60. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Erlanger Medical Center — Chattanooga, Tennessee, United States

Full record on ClinicalTrials.gov

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