Superior Hypogastric Plexus Blockade in Laparoscopic Hysterectomy

NCT03427840 | Unknown

• 1 other identifier: U1111-1208-8608
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Superior Hypogastric Plexus Block; Hysterectomy; Minimally Invasive Surgery; Laparoscopy; Pain, Postoperative; Gynecologic Disease

Keywords

Superior Hypogastric Plexus Block; Hysterectomy; Minimally invasive surgery; Laparoscopy; Pain; Gynecologic Disease

Outcome Measures

Primary Outcomes (5)

• 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)

• 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)

Secondary Outcomes (3)

• 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)

Study Arms (2)

Hypo

The participants with a superior hypogastric block

Procedure: Procedure/Surgery: superior hypogastric block

NoHypo

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)

Interventions

Procedure/Surgery: superior hypogastric block PROCEDURE

superior hypogastric blockade during surgery

Hypo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: patients who are scheduled for hysterectomy
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patients who are scheduled for elective laparoscopic hysterectomy under general anesthesia.

You may qualify if:

• ASA I - II
• Elective laparoscopic hysterectomy

You may not qualify if:

• ASA III
• Different kind of surgery
• Known allergy to local anesthetic drugs
• Different analgesia protocol (ie: epidural, TAP block,..)
• Refusal of the patient

Sponsors & Collaborators

• Derince Training and Research Hospital: lead

Study Sites (1)

Derince Training and Research Hospital

Kocaeli, Derince, 41900, Turkey (Türkiye)

RECRUITING

Related Publications (5)

• 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.

  PMID: 28381342 RESULT

• 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.

  PMID: 25814108 RESULT

• 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.

  PMID: 27208713 RESULT

• 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.

  PMID: 12945023 RESULT

• 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.

  PMID: 30165185 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Genital Diseases, Female; Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Hande Aytuluk, MD

  Derince Training and Research Hospital

  PRINCIPAL INVESTIGATOR

• Ahmet Kale, Prof

  Derince Training and Research Hospital

  STUDY CHAIR

• Gulfem Basol, MD

  Derince Training and Research Hospital

  STUDY CHAIR

Central Study Contacts

Hande Aytuluk, MD

CONTACT

+902623198000; handegrbz@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Principal investigator

Study Record Dates

• First Submitted: February 1, 2018
• First Posted: February 9, 2018
• Study Start: March 18, 2018
• Primary Completion: June 30, 2018
• Study Completion: July 1, 2018
• Last Updated: March 20, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)