Superior Hypogastric Plexus Blockade in Laparoscopic Hysterectomy

Efficacy of Intraoperative Superior Hypogastric Plexus Blockade for Postoperative Pain in Laparoscopic Hysterectomy

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.

Study Overview

• Status: Unknown
• Conditions: Pain, Postoperative; Hysterectomy; Laparoscopy; Gynecologic Disease; Minimally Invasive Surgery; Superior Hypogastric Plexus Block
• Intervention / Treatment: Procedure: Procedure/Surgery: superior hypogastric block

Detailed Description

Laparoscopic surgeries have many advantages over open surgeries. Laparoscopic procedures are mostly preferred for surgical treatment of gynecologic diseases, because of best cosmetically results, less perioperative complications, early recovery, and less postoperative pain.

There are many undesirable effects of systemic reactions to the pain. Accordingly, multi-modal analgesic approach (including nerve blocks) for postoperative acute pain can decrease the side effects of the drugs (especially opioids) significantly.

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, per-cutaneous technique can be done under the guidance of cameras.

SHP block has been performed by anesthetists or surgeons in Kocaeli Derince Training and Research Hospital regularly since they have discovered the advantages of this block technique. SHP can be useful to decrease postoperative pain scores and opioid or NSAID consumption significantly.

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• Turkey
  • Derince
    • Kocaeli, Derince, Turkey, 41900
      • Recruiting
      • Derince Training and Research Hospital
      • Contact: Hande G. Aytuluk, MD; Phone Number: +90 533 651 56 50; Email: handegrbz@gmail.com
      • Contact: Gulfem Basol, MD; Phone Number: +90 530 140 23 20; Email: glfem412010@hotmail.com
      • Principal Investigator: Hande G. Aytuluk, MD
      • Sub-Investigator: Gulfem Basol, MD
      • Sub-Investigator: Ahmet Kale, Prof

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• ASA I - II
• Elective laparoscopic hysterectomy

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hypo; The participants with a superior hypogastric block	Procedure: Procedure/Surgery: superior hypogastric block; superior hypogastric blockade during surgery
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative hemodynamics	(If the patient is received a SHP block intraoperatively) post-block hemodynamical parametres will be noted down	from SHP block to the end of the surgery (approximately 15 min)
length of stay	length of hospital stay time will be noted	3-5 days (expected)
complications due to SHP block	intra/postoperative complications will be noted. (ie: intra-vascular local anesthetic injection, vascular puncture, hemodynamical changes after injection,.. )	3-5 days (from surgery to discharge from the hospital)

Collaborators and Investigators

• Sponsor: Derince Training and Research Hospital
• Investigators: Study Chair: Gulfem Basol, MD, Derince Training and Research Hospital; Study Chair: Ahmet Kale, Prof, Derince Training and Research Hospital; Principal Investigator: Hande Aytuluk, MD, Derince Training and Research Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2018
• Primary Completion (Anticipated): June 30, 2018
• Study Completion (Anticipated): July 1, 2018

Study Registration Dates

• First Submitted: February 1, 2018
• First Submitted That Met QC Criteria: February 3, 2018
• First Posted (Actual): February 9, 2018

Study Record Updates

• Last Update Posted (Actual): March 20, 2018
• Last Update Submitted That Met QC Criteria: March 17, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Pain; Minimally invasive surgery; Laparoscopy; Hysterectomy; Superior Hypogastric Plexus Block; Gynecologic Disease
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: U1111-1208-8608

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: The investigators do not prefer to share the study plan and records.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No