NCT03268525

The Effect of Local Anesthesia on Postoperative Pain in Vaginal Hysterectomy

The Effect of Local Anesthesia on Postoperative Pain in Vaginal Hysterectomy: A Randomized Controlled Trial

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Wolfson Medical Center · Other Government
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The investigators aim is to study the effect of pre-operative local anesthetic on post vaginal hysterectomy pain.

Detailed description

This is a double-blinded, randomized, controlled trial. Women who undergone elective vaginal hysterectomy and gave their informed consent were included. Exclusion criteria included additional abdominal, chronic pelvic pain, malignancy, and allergy to Bupivacaine. Solutions of either Bupivacaine-Hydrochloride 0.5%, or Sodium-Chloride 0.9% as a placebo, were prepared prior to surgery, according to randomization. The chosen solution was injected before incision, as a modified paracervical block, and in each resection line (sacro-uterine and cardinal ligaments). The amount of fluid administered was 10 ml. When colporrhaphy was also performed, an additional 5 ml of solution were injected in the midline of the vaginal wall prior to each incision line. By utilizing the 10 cm Visual-analogue-scale (VAS) we examined the differences in post-operative pain at rest at 3, 8, and 24 hours, and during ambulation at 8 and 24 hours using multivariate linear regression models. We also assessed the differences in analgesics given at the different time points between the groups using multivariate negative binomial regression models.

Conditions

• Pain, Postoperative

Interventions

Type	Name	Description
DRUG	Marcaine 0.5 % Injectable Solution	Local infiltration by Marcaine 0.5% Injectable Solution prior to incision
DRUG	Sodium Chloride 0.9%	Local infiltration by Sodium Chloride 0.9% prior to incision

Timeline

• Start date: 2017-09-01
• Primary completion: 2019-11-30
• Completion: 2019-11-30
• First posted: 2017-08-31
• Last updated: 2020-06-09

Locations

1 site across 1 country: Israel