NCT03428152|CompletedResults
Superior Hypogastric Blockade for Postoperative Pain
The Efficacy of Superior Hypogastric Blockade for Postoperative Pain
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The Efficacy of Superior Hypogastric Blockade for Postoperative Pain
Sponsor study identifier
observational
78
1 country
1
Study Start
February 9, 2018
Actual (reported)Primary Completion
July 23, 2018
Actual (reported)Study Completion
July 24, 2018
Actual (reported)The primary indication for superior hypogastric (SHP) block is visceral pelvic pain, most commonly from malignancy of the ovary, uterus, cervix, bladder, rectum or prostate. Percutaneous SHP blocks should be done under guidance of ultrasonography, fluoroscopy, magnetic resonance or computed tomography. Because of the close proximity of SHP to major vessels, and structures like vertebral column (for posterior) and guts (for anterior) are being on the way of the needle, these percutaneous blocks are associated with serious complications. Performing SHP during hysterectomy surgery, gives advantages to rule out these complications by exploring the whole intraabdominal anatomy. The investigators' theory is to find out if SHP blocks (during pelvic surgery) are useful for decreasing VAS pain scores and opioid consumption for postoperative pain.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 24, 2018
Actual (reported)Click on a node to explore related trials.
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.
January 30, 2018
Actual (reported)February 9, 2018
Actual (reported)February 9, 2018
Actual (reported)July 23, 2018
Actual (reported)July 24, 2018
Actual (reported)June 3, 2019
Actual (reported)Postoperative Pain Scores
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) (PACU: Post-anesthesia care unit) VAS-PACU: VAS scores at PACU VAS 1: VAS scores at postoperative 1st hour (ward) VAS 6: VAS scores at postoperative 6th hour (ward) VAS 12: VAS scores at postoperative 12th hour (ward) VAS 24: VAS scores at postoperative 24th hour (ward) VAS 48: VAS scores at postoperative 48th hour (ward)
postoperative 48 hour follow-up (PACU and ward)
Postoperative Analgesic Consumption
Total number of non-steroid anti-inflammatory drug (NSAID) and opioid vials that are applied to patients in post-anesthesia care unit (PACU) and at ward will be recorded. Target VAS score for NSAID is \>4; if there is no response to NSAID and pain is worsening opioid drugs will be applied (this is our routine clinical practice) NSAID: Diclofenac sodium 75mg per vial; opioid: Tramadol 100mg per vial.
postoperative 48 hour follow-up (PACU and ward)
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 retro-peritoneum 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 hysterectomy under general anesthesia.
Derince Training and Research Hospital
Kocaeli, Derince, 41900, Turkey (Türkiye)
Plancarte R, de Leon-Casasola OA, El-Helaly M, Allende S, Lema MJ. Neurolytic superior hypogastric plexus block for chronic pelvic pain associated with cancer. Reg Anesth. 1997 Nov-Dec;22(6):562-8.
de Leon-Casasola OA, Kent E, Lema MJ. Neurolytic superior hypogastric plexus block for chronic pelvic pain associated with cancer. Pain. 1993 Aug;54(2):145-151. doi: 10.1016/0304-3959(93)90202-Z.
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.
Hande G. Aytuluk, MD
Derince Training and Research Hospital
Gulfem Basol, MD
Derince Training and Research Hospital
Ahmet Kale, Prof
Derince Training and Research Hospital
Canan Balci, Assoc Prof
Derince Training and Research Hospital
78 participants (actual enrollment reported by the registry).
First Submitted
January 30, 2018
First Posted
February 9, 2018
Study Start
February 9, 2018
Actual (reported)Additive Effect of Intravenous Acetaminophen on Postoperative Pain Control
Rescue Analgesic Time
48 hours (time to the first analgesic demand will be recorded)
Duration of Operation
from the induction of anesthesia and the end of the surgery
Length of Hospital Stay
assessed up to 1 week
Number of Participants With Complications Due to SHP Block
From the SHP block time (intraoperative) until discharge
Contact the study team to confirm eligibility.
Choi JW, Kim WH, Lee CJ, Sim WS, Park S, Chae HB. The Optimal Approach for a Superior Hypogastric Plexus Block. Pain Pract. 2018 Mar;18(3):314-321. doi: 10.1111/papr.12603. Epub 2017 Jul 6.
Turker G, Basagan-Mogol E, Gurbet A, Ozturk C, Uckunkaya N, Sahin S. A new technique for superior hypogastric plexus block: the posteromedian transdiscal approach. Tohoku J Exp Med. 2005 Jul;206(3):277-81. doi: 10.1620/tjem.206.277.
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.
Rapp H, Ledin Eriksson S, Smith P. Superior hypogastric plexus block as a new method of pain relief after abdominal hysterectomy: double-blind, randomised clinical trial of efficacy. BJOG. 2017 Jan;124(2):270-276. doi: 10.1111/1471-0528.14119. Epub 2016 Jun 12.
Aytuluk HG, Kale A, Astepe BS, Basol G, Balci C, Colak T. Superior Hypogastric Plexus Blocks for Postoperative Pain Management in Abdominal Hysterectomies. Clin J Pain. 2020 Jan;36(1):41-46. doi: 10.1097/AJP.0000000000000767.
Primary Completion
July 23, 2018
Actual (reported)Study Completion
July 24, 2018
Actual (reported)Last Updated
March 13, 2024
Results First Posted
June 3, 2019
Record last verified: 2024-02
The investigators do not prefer to share the study plan and records.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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