MedTrace Logo

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

NCT03027661 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2018-11-15

Study results available
· View outcomes & findings →

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

Conditions

  • Pain, Postoperative

Interventions

DRUG

Bupivacaine

Inject 10 mL of 0.5% bupivacaine into cervical stroma

DRUG

0.9% Sodium Chloride

Inject 10 mL of 0.9% NaCl into cervical stroma

Sponsors & Collaborators

  • University of Tennessee

    lead OTHER

Principal Investigators

  • Steven J Radtke, MD · UT College of Medicine MIGS Fellow & Faculty

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-01
Primary Completion
2018-06-30
Completion
2018-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03027661 on ClinicalTrials.gov