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
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Experimental: Pre-sacral nerve block
10 mL bupivacaine (5mg/mL)
10 mL (5mg/mL)
Sham Comparator: Sham block
10 mL normal saline
10 mL normal saline
- 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).
- 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).
- 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).
- 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
- 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
- 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.
- Estimated blood loss [ Time Frame: On day of surgery ]Amount of blood lost during the surgery (as reported by the surgical team)
- Operative Time [ Time Frame: On day of surgery ]Duration of surgery (from first skin incision to time of extubation)
- Time to first ambulation [ Time Frame: On day of surgery ]Duration of time from end of surgery (time of extubation) until first ambulation
- Time to first void [ Time Frame: On day of surgery ]Duration of time from end of surgery (time of extubation) until first urination
- Time to discharge [ Time Frame: On day of surgery ]Total duration of time between end of surgery (time of extubation) until discharge home
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
|Contact: Mara Sobel, MDemail@example.com|
|Mount Sinai Hospital||Recruiting|
|Toronto, Ontario, Canada, M5G1Z5|
|Contact: Mara Sobel, MD 416-586-4800 ext 8273 firstname.lastname@example.org|
|Principal Investigator:||Mara Sobel, MD||MOUNT SINAI HOSPITAL|