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The Effect of Local Anesthesia on Postoperative Pain in Vaginal Hysterectomy

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Early Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Marcaine 0.5 % Injectable Solution
Sodium Chloride 0.9%
Sponsored by
Wolfson Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain, Postoperative

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Elective vaginal hysterectomy on benign indication

Exclusion Criteria:

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

Sites / Locations

  • Wolfson medical center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Study

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Pain at movement
Movement-evoked pain will be scored after the operation

Secondary Outcome Measures

pain at rest
Pain at rest will be scored with the woman lying in bed after the operation

Full Information

First Posted
August 22, 2017
Last Updated
June 4, 2020
Sponsor
Wolfson Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03268525
Brief Title
The Effect of Local Anesthesia on Postoperative Pain in Vaginal Hysterectomy
Official Title
The Effect of Local Anesthesia on Postoperative Pain in Vaginal Hysterectomy: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
November 30, 2019 (Actual)
Study Completion Date
November 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wolfson Medical Center

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Drug group versus placebo group
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The surgeons, the pain assessing researchers, and the participating women will all be blinded to what the syringes contain.
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Marcaine 0.5 % Injectable Solution
Other Intervention Name(s)
Study
Intervention Description
Local infiltration by Marcaine 0.5% Injectable Solution prior to incision
Intervention Type
Drug
Intervention Name(s)
Sodium Chloride 0.9%
Other Intervention Name(s)
Placebo
Intervention Description
Local infiltration by Sodium Chloride 0.9% prior to incision
Primary Outcome Measure Information:
Title
Pain at movement
Description
Movement-evoked pain will be scored after the operation
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
pain at rest
Description
Pain at rest will be scored with the woman lying in bed after the operation
Time Frame
24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Elective vaginal hysterectomy on benign indication Exclusion Criteria: additional abdominal, chronic pelvic pain, malignancy, and allergy to Bupivacaine.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shimon Ginat, MD
Organizational Affiliation
Wolfson Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Wolfson medical center
City
H̱olon
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Local Anesthesia on Postoperative Pain in Vaginal Hysterectomy

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