NCT03427840|Unknown
Superior Hypogastric Plexus Blockade in Laparoscopic Hysterectomy
Efficacy of Intraoperative Superior Hypogastric Plexus Blockade for Postoperative Pain in Laparoscopic Hysterectomy
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Efficacy of Intraoperative Superior Hypogastric Plexus Blockade for Postoperative Pain in Laparoscopic Hysterectomy
Sponsor study identifier
observational
60
1 country
1
Study Start
March 18, 2018
Actual (reported)Primary Completion
June 30, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 1, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The primary indication for superior hypogastric plexus (SHP) block is visceral pelvic pain, most commonly from malignancy of the ovary, uterus, cervix, bladder, rectum or prostate. Per-cutaneous SHP blocks should be done under guidance of ultrasonography, fluoroscopy, magnetic resonance or computed tomography. During minimally invasive laparoscopic surgery, percutaneous technique can be done under the guidance of cameras.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 1, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 1, 2018
Actual (reported)February 9, 2018
Actual (reported)March 18, 2018
Actual (reported)June 30, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 1, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
postoperative pain scores (PACU)
Patients' pain scores will be scored with a 10 cm Visual Analogue Scale (VAS). Each will be scored between 0-10 (0: no pain; 10: worst pain ever)
1 hour (postoperatively)
postoperative opioid/NSAID consumption (PACU)
nonsteroid antiinflammatory drugs (NSAID) or opioid drugs that are applied to patients will be noted down.
1 hour (postoperatively)
rescue analgesic time
Time to first analgesic demand at gynecology ward (after transfer from PACU to gynecology ward)
48 hours (first analgesic demand time will be noted down)
The participants with a superior hypogastric block
The participants without a superior hypogastric block; the patients with an epidural catheter, who receive a different block technique (ie: TAP block), or who are unsuitable for SHP block (ie: if retroperitone is opened intraoperatively by the surgeon)
superior hypogastric blockade during surgery
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The patients who are scheduled for elective laparoscopic hysterectomy under general anesthesia.
Derince Training and Research Hospital
Kocaeli, Derince, 41900, Turkey (Türkiye)
Song T, Kim MK, Jung YW, Yun BS, Seong SJ, Choi CH, Kim TJ, Lee JW, Bae DS, Kim BG. Minimally invasive compared with open surgery in patients with borderline ovarian tumors. Gynecol Oncol. 2017 Jun;145(3):508-512. doi: 10.1016/j.ygyno.2017.03.019. Epub 2017 Apr 2.
Lovich-Sapola J, Smith CE, Brandt CP. Postoperative pain control. Surg Clin North Am. 2015 Apr;95(2):301-18. doi: 10.1016/j.suc.2014.10.002. Epub 2015 Jan 24.
Hande Aytuluk, MD
Derince Training and Research Hospital
Ahmet Kale, Prof
Derince Training and Research Hospital
Gulfem Basol, MD
Derince Training and Research Hospital
First Submitted
February 1, 2018
First Posted
February 9, 2018
Study Start
March 18, 2018
Actual (reported)Primary Completion
June 30, 2018
Estimated (date passed)Inflammatory Markers in Natural Orifice Hysterectomies
postoperative pain scores (ward)
Patients' pain scores will be scored with a 10 cm Visual Analogue Scale (VAS). Each will be scored between 0-10 (0: no pain; 10: worst pain ever)
48 hours (postoperatively)
postoperative opioid/NSAID consumption (ward)
NSAID or opioid drugs that are applied to patients will be noted down. Target VAS score for NSAID is \>4; if there is no response to NSAID and pain is worsening opioid drugs will be applied
48 hours (total)
Intraoperative hemodynamics
from SHP block to the end of the surgery (approximately 15 min)
length of stay
3-5 days (expected)
complications due to SHP block
3-5 days (from surgery to discharge from the hospital)
Contact the study team to confirm eligibility.
Sindt JE, Brogan SE. Interventional Treatments of Cancer Pain. Anesthesiol Clin. 2016 Jun;34(2):317-39. doi: 10.1016/j.anclin.2016.01.004.
Erdine S, Yucel A, Celik M, Talu GK. Transdiscal approach for hypogastric plexus block. Reg Anesth Pain Med. 2003 Jul-Aug;28(4):304-8. doi: 10.1016/s1098-7339(03)00191-3.
Aytuluk HG, Kale A, Basol G. Laparoscopic Superior Hypogastric Blocks for Postoperative Pain Management in Hysterectomies: A New Technique for Superior Hypogastric Blocks. J Minim Invasive Gynecol. 2019 May-Jun;26(4):740-747. doi: 10.1016/j.jmig.2018.08.008. Epub 2018 Aug 28.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 1, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 20, 2018
Record last verified: 2018-03
The investigators do not prefer to share the study plan and records.
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Source: ClinicalTrials.gov.
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