CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 41 enrolled
Drug / intervention
Bupivacaine +1 moredrug
Likely dose
Bupivacaine 10 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03027661
NCT03027661Phase 3Completed

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

University of Tennessee·interventional·Posted Jan 23, 2017·Updated Nov 15, 2018

In Brief

A Phase 3 clinical trial evaluating Bupivacaine and 0.9% Sodium Chloride for Pain, Postoperative. Completed, enrolled 41 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 23, 2017
Enrollment StartAug 1, 2017
Primary CompletionJun 30, 2018
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 9.4 years ago

Interventions

Bupivacainedrug

Inject 10 mL of 0.5% bupivacaine into cervical stroma

0.9% Sodium Chloridedrug

Inject 10 mL of 0.9% NaCl into cervical stroma