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The Effect of Pre-sacral Nerve Block on Immediate Post-operative Pain Following Laparoscopic Hysterectomy.

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ClinicalTrials.gov Identifier: NCT03646006
Recruitment Status : Recruiting
First Posted : August 24, 2018
Last Update Posted : August 27, 2018
Sponsor:
Information provided by (Responsible Party):
Mara Sobel, Mount Sinai Hospital, Canada

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.


Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: Bupivacaine Drug: Placebo Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial (RCT) Comparing Presacral Nerve Block Versus Sham Block on Post-operative Pain in Women Undergoing Total Laparoscopic Hysterectomy.
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy
Drug Information available for: Bupivacaine

Arm Intervention/treatment
Experimental: Pre-sacral nerve block
10 mL bupivacaine (5mg/mL)
Drug: Bupivacaine
10 mL (5mg/mL)

Sham Comparator: Sham block
10 mL normal saline
Drug: Placebo
10 mL normal saline




Primary Outcome Measures :
  1. Post-operative pain at 3 hours [ Time Frame: 3 hours post-operatively ]
    Pain measured on a visual analogue scale (VAS). Range will be from zero (no pain) to 10 (most pain).


Secondary Outcome Measures :
  1. Post-operative pain at 1 hour [ Time Frame: 1 hour post-operatively ]
    Pain measured on a visual analogue scale (VAS). Range will be from zero (no pain) to 10 (most pain).

  2. Post-operative pain at 2 hours [ Time Frame: 2 hours post-operatively ]
    Pain measured on a visual analogue scale (VAS). Range will be from zero (no pain) to 10 (most pain).

  3. Post-operative narcotic consumption [ Time Frame: On day of surgery ]
    Total dose of narcotics consumed by the patient from end of surgery (time of extubation) until time of discharge

  4. Post-operative anti-emetic consumption [ Time Frame: On day of surgery ]
    Total dose of anti-emetics consumed by the patient from end of surgery (time of extubation) until time of discharge

  5. Adverse Events [ Time Frame: 6 weeks following surgery ]
    Any adverse events described during the operation, in the post-anaesthesia care unit (PACU) or reported by the patient at the 6-week post-operative visit.


Other Outcome Measures:
  1. Estimated blood loss [ Time Frame: On day of surgery ]
    Amount of blood lost during the surgery (as reported by the surgical team)

  2. Operative Time [ Time Frame: On day of surgery ]
    Duration of surgery (from first skin incision to time of extubation)

  3. Time to first ambulation [ Time Frame: On day of surgery ]
    Duration of time from end of surgery (time of extubation) until first ambulation

  4. Time to first void [ Time Frame: On day of surgery ]
    Duration of time from end of surgery (time of extubation) until first urination

  5. Time to discharge [ Time Frame: On day of surgery ]
    Total duration of time between end of surgery (time of extubation) until discharge home



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03646006


Contacts
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Contact: Mara Sobel, MD 416-586-4800 mara.sobel@sinaihealthsystem.ca

Locations
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Canada, Ontario
Mount Sinai Hospital Recruiting
Toronto, Ontario, Canada, M5G1Z5
Contact: Mara Sobel, MD    416-586-4800 ext 8273    mara.sobel@sinaihealthsystem.ca   
Sponsors and Collaborators
Mount Sinai Hospital, Canada
Investigators
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Principal Investigator: Mara Sobel, MD MOUNT SINAI HOSPITAL

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Responsible Party: Mara Sobel, Assistant Professor, Core Obstetrics and Gynecology, Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier: NCT03646006     History of Changes
Other Study ID Numbers: MSH REB 16-0203-A
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: August 27, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents