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

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

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: Marcaine 0.5 % Injectable Solution; Drug: Sodium Chloride 0.9%

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Israel
  • H̱olon, Israel
    • Wolfson Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Elective vaginal hysterectomy on benign indication

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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.	Drug: Marcaine 0.5 % Injectable Solution; Local infiltration by Marcaine 0.5% Injectable Solution prior to incision; Other Names: Study
PLACEBO_COMPARATOR: 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.	Drug: Sodium Chloride 0.9%; Local infiltration by Sodium Chloride 0.9% prior to incision; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain at movement	Movement-evoked pain will be scored after the operation	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain at rest	Pain at rest will be scored with the woman lying in bed after the operation	24 hours

Collaborators and Investigators

• Sponsor: Wolfson Medical Center
• Investigators: Study Director: Shimon Ginat, MD, Wolfson Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2017
• Primary Completion (ACTUAL): November 30, 2019
• Study Completion (ACTUAL): November 30, 2019

Study Registration Dates

• First Submitted: August 22, 2017
• First Submitted That Met QC Criteria: August 30, 2017
• First Posted (ACTUAL): August 31, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 9, 2020
• Last Update Submitted That Met QC Criteria: June 4, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 0156-17-WOMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No