Clinical trial NCT03427840: Superior Hypogastric Plexus Blockade in Laparoscopic Hysterectomy
Official title: Efficacy of Intraoperative Superior Hypogastric Plexus Blockade for Postoperative Pain in Laparoscopic Hysterectomy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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
Lead sponsor: Derince Training and Research Hospital
Sponsor class: OTHER
First posted: 2018-02-09
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients who are scheduled for elective laparoscopic hysterectomy under general anesthesia.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: postoperative pain scores (PACU)
timeFrame: 1 hour (postoperatively)
measure: postoperative opioid/NSAID consumption (PACU)
timeFrame: 1 hour (postoperatively)
measure: rescue analgesic time
timeFrame: 48 hours (first analgesic demand time will be noted down)
measure: postoperative pain scores (ward)
timeFrame: 48 hours (postoperatively)
measure: postoperative opioid/NSAID consumption (ward)
timeFrame: 48 hours (total)
Secondary outcomes:
measure: Intraoperative hemodynamics
timeFrame: from SHP block to the end of the surgery (approximately 15 min)
measure: length of stay
timeFrame: 3-5 days (expected)
measure: complications due to SHP block
timeFrame: 3-5 days (from surgery to discharge from the hospital)
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Derince Training and Research Hospital
state: Derince
Study officials:
affiliation: Derince Training and Research Hospital
name: Hande Aytuluk, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Derince Training and Research Hospital
name: Ahmet Kale, Prof
role: STUDY_CHAIR
affiliation: Derince Training and Research Hospital
name: Gulfem Basol, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.