The Effect of Local Anesthesia on Postoperative Pain in Vaginal Hysterectomy

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03268525
• Other study ID #: 0156-17-WOMC
• Status: Completed
• Phase: Early Phase 1
• Start date: September 1, 2017
• Est. completion date: November 30, 2019

Study information

• Verified date: June 2020
• Source: Wolfson Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 30, 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Elective vaginal hysterectomy on benign indication

Exclusion Criteria:

additional abdominal, chronic pelvic pain, malignancy, and allergy to Bupivacaine.

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Marcaine 0.5 % Injectable Solution
Local infiltration by Marcaine 0.5% Injectable Solution prior to incision
• Sodium Chloride 0.9%
Local infiltration by Sodium Chloride 0.9% prior to incision

Locations

Country	Name	City	State
Israel	Wolfson medical center	H_olon

Sponsors (1)

Lead Sponsor	Collaborator
Wolfson Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain at movement	Movement-evoked pain will be scored after the operation	24 hours
Secondary	pain at rest	Pain at rest will be scored with the woman lying in bed after the operation	24 hours