The Effect of Local Anesthesia on Postoperative Pain in Vaginal Hysterectomy

NCT ID: NCT03268525

Last Updated: 2020-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2019-11-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Study

Marcaine 0.5 % Injectable Solution will be injected before incision, and in a systematic fashion as a modified paracervical block. First, 2 ml will be injected through the vaginal fornices at 03.00, 06.00, 09.00, and 12.00 hours at 2 cm depth. Thus, 8 ml will be systematically injected around the cervical circumference before incision. In addition, 1 ml of the solution will be injected in each resection line (sacro-uterine and cardinal ligaments), adding up to a total of 10 ml. In case of performing additional anterior/ posterior colporrhaphy, additional solution of Marcaine 0.25%will be prepared: 5 ml of the solution will be injected to the cutting line of the anterior/ posterior vaginal wall, respectively, prior to incision.

Group Type: ACTIVE_COMPARATOR

Marcaine 0.5 % Injectable Solution

Intervention Type: DRUG

Local infiltration by Marcaine 0.5% Injectable Solution prior to incision

Control

Sodium Chloride 0.9% will be injected before incision, and in a systematic fashion as a modified paracervical block. First, 2 ml will be injected through the vaginal fornices at 03.00, 06.00, 09.00, and 12.00 hours at 2 cm depth. Thus, 8 ml will be systematically injected around the cervical circumference before incision. In addition, 1 ml of the solution will be injected in each resection line (sacro-uterine and cardinal ligaments), adding up to a total of 10 ml. In case of performing additional anterior/ posterior colporrhaphy, additional solution of Sodium Chloride 0.9% will be prepared: 5 ml of the solution will be injected to the cutting line of the anterior/ posterior vaginal wall, respectively, prior to incision.

Group Type: PLACEBO_COMPARATOR

Sodium Chloride 0.9%

Intervention Type: DRUG

Local infiltration by Sodium Chloride 0.9% prior to incision

Interventions

Marcaine 0.5 % Injectable Solution

Local infiltration by Marcaine 0.5% Injectable Solution prior to incision

Intervention Type: DRUG

Sodium Chloride 0.9%

Local infiltration by Sodium Chloride 0.9% prior to incision

Intervention Type: DRUG

Other Intervention Names

Study; Placebo

Eligibility Criteria

Inclusion Criteria

• Elective vaginal hysterectomy on benign indication

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Wolfson Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Ohad Gluck

OBGYN resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shimon Ginat, MD

Role: STUDY_DIRECTOR

Wolfson Medical Center

Locations

Wolfson medical center

Holon, , Israel

Countries

Israel

Other Identifiers

0156-17-WOMC

Identifier Type: -

Identifier Source: org_study_id