The Effect of Local Anesthesia on Postoperative Pain in Vaginal Hysterectomy

NCT03268525 | Completed Early Phase 1 DMC

• 1 other identifier: 0156-17-WOMC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• Pain at movement

  Movement-evoked pain will be scored after the operation

  24 hours

Secondary Outcomes (1)

• pain at rest

  24 hours

Study Arms (2)

Study

ACTIVE COMPARATOR

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

Control

PLACEBO COMPARATOR

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%

Interventions

Marcaine 0.5 % Injectable Solution DRUG

Local infiltration by Marcaine 0.5% Injectable Solution prior to incision

Also known as: Study

Study

Sodium Chloride 0.9% DRUG

Local infiltration by Sodium Chloride 0.9% prior to incision

Also known as: Placebo

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective vaginal hysterectomy on benign indication

You may not qualify if:

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

Sponsors & Collaborators

• Wolfson Medical Center: lead

Study Sites (1)

Wolfson medical center

Holon, Israel

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Shimon Ginat, MD

  Wolfson Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The surgeons, the pain assessing researchers, and the participating women will all be blinded to what the syringes contain.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: OBGYN resident

Model Details: Drug group versus placebo group

Study Record Dates

• First Submitted: August 22, 2017
• First Posted: August 31, 2017
• Study Start: September 1, 2017
• Primary Completion: November 30, 2019
• Study Completion: November 30, 2019
• Last Updated: June 9, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)