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Completed

NCT Number: NCT03268525

The Effect of Local Anesthesia on Postoperative Pain in Vaginal Hysterectomy

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Wolfson medical center

Holon, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Elective vaginal hysterectomy on benign indication

Exclusion criteria

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

Treatment and study plan

Marcaine 0.5 % Injectable Solution

Drug

Local infiltration by Marcaine 0.5% Injectable Solution prior to incision

Other names: Study

Sodium chloride 0.9%

Drug

Local infiltration by Sodium Chloride 0.9% prior to incision

Other names: Placebo

Primary outcomes

  1. Pain at movement

    Time frame: 24 hours

    Movement-evoked pain will be scored after the operation

Secondary outcomes

  1. pain at rest

    Time frame: 24 hours

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

Sponsors and collaborators

Lead sponsor

Wolfson Medical Center

Other Gov

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 31, 2017
Registry last updated
Jun 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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