Recruiting

Pre-sacral Nerve Block

Sponsor:

Mount Sinai Hospital, Canada

Code:

NCT03646006

Conditions

Pain, Postoperative

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Bupivacaine

Placebo

Study Details

Brief summary:

Hysterectomy (removal of the uterus) is the most common major gynecologic surgery performed in Canada. With a focus on minimally invasive techniques and optimization of peri-operative pain control, gynaecologists have made great strides towards reducing hospital stay and accelerating post-operative recovery. These are essential achievements, both for patients and their families and for our resource-limited public healthcare system.

Optimization of peri-operative pain control is multifactorial and includes, for example, administration of pre-operative analgesics, infiltration of incision sites with local anesthetic and provision of post-operative pain medications. As the understanding of pain mechanisms evolves, the incorporation of intra-operative nerve blocks has become yet another effective strategy to reduce post-operative pain.

The presacral nerve plexus, which carries nerve fibers from the uterus to the brain, is an important pathway that transmits midline pelvic pain in women. Destruction of the pre-sacral nerves has been shown to provide excellent pain control in a variety of clinical settings.

While transection of the presacral nerve at the time of surgery is technically challenging, instilling a presacral nerve block is surprisingly straightforward making this technique safe to perform in the hands of many gynecologists. In this technique, local anesthetic is instilled into the presacral space using a needle inserted through the abdomen.

Given that the presacral nerve plexus is an integral pain pathway for the uterus, the investigators hypothesize that the addition of a presacral nerve block during laparoscopic (camera surgery) hysterectomy would confer an additional reduction in immediate post-operative pain. The proposed study therefore aims to look at the impact of presacral nerve block versus a sham (blank) block on immediate post-operative pain in a group of women scheduled to undergo laparoscopic hysterectomy.

Conditions

Pain, Postoperative

Study ID

NCT03646006

Start date

Aug 1, 2018

Status verified date

Aug, 2018

Completion date

Jul, 2019

Anticipated

Primary completion date

Mar, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Women undergoing elective total laparoscopic hysterectomy
  • Age > 18 years

Exclusion Criteria:

  • Previous presacral neurectomy
  • Concurrent surgical procedure other than salpingectomy and/or oophorectomy
  • Gynecological cancer beyond stage 1 disease
  • Chronic narcotic consumption
  • Fibromyalgia
  • Inability to provide consent

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Pre-sacral nerve block

10 mL bupivacaine (5mg/mL)

sham comparator: Sham block

10 mL normal saline

Interventions

Bupivacaine

10 mL (5mg/mL)

Placebo

10 mL normal saline

Primary outcome measure

  • Post-operative pain at 3 hours [ Time Frame: 3 hours post-operatively ]

Central Contacts and Locations

Central contacts

Locations

Mount Sinai Hospital

Recruiting

Toronto, Ontario, Canada, M5G1Z5

Contacts

More Information

Sponsor

Mount Sinai Hospital, Canada

Last update posted

Aug 27, 2018

Last verified

Aug, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mount Sinai Hospital, Canada on 2018-08-27.