Clinical trial NCT03428152: Superior Hypogastric Blockade for Postoperative Pain
Official title: The Efficacy of Superior Hypogastric Blockade for Postoperative Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Superior Hypogastric Plexus Block
Hysterectomy
Pain, Postoperative
Gynecologic Disease
Keywords: superior hypogastric plexus block
hysterectomy
postoperative pain
Lead sponsor: Derince Training and Research Hospital
Sponsor class: OTHER
First posted: 2018-02-09
Enrollment: 78
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 hysterectomy under general anesthesia.

Brief summary: 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.

Detailed description: Nerve blocks are frequently used in daily practice as an anesthetic and analgesia technique for surgery, postoperative pain and chronic pain. Total abdominal hysterectomy causes significant postoperative pain. Epidural blocks are frequently preferred for postoperative pain control, since most of the anesthetists are skilled with neuraxial blocks. However, an epidural catheter placement and epidural injections have some side effects and complications.

Pelvis is innervated by thoracolumbar and sacral segments. Autonomic (sympathetic and parasympathetic) and somatic (motor and sensory) nerves provide innervation of pelvis. The sympathetic nervous system, which transmits nociceptive messages from the viscera to brain, plays an important role in the transmission of visceral pain. Generally, in order to block transmission of nociceptive information from the pelvic viscera to the spinal cord, interruption of sympathetic pathways will be necessary. The sympathetic nerve block on the sympathetic nervous system for the management of chronic pelvic pain has been proposed at three main levels: ganglion impar, hypogastric plexus and L2 lumbar sympathetic blocks. By following the pelvic anatomy, there could be an alternative way for acute pain relief for abdominal hysterectomy: superior hypogastric block.

The superior hypogastric plexus lies retroperitoneally in front of L4 as a bunch of fibers. As these fibers descend, at the level of L5 they divide into the hypogastric nerves. The hypogastric nerves pass downward from L5-S1, following the concave curve of the sacrum and passing on each side of the rectum to form the inferior hypogastric plexus. These nerves continue their down¬ward course along each side of the bladder to provide innervation to the pelvic viscera and vasculature.

The primary indication for superior hypogastric block (SHNB) is visceral pelvic pain, most commonly from malignancy of the ovary, uterus, cervix, bladder, rectum or prostate. Percutaneous SHP blocks can be done by using posterior approach (transdiscal) and paravertebral) and anterior techniques. All of these interventions 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 complications.

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. Performing SHP block during hysterectomy surgery, gives advantages to rule out these complications by exploring the whole intraabdominal anatomy. Based on the complexity of the pelvic innervation, SHP blocks do not offer a total painless period like central neuraxial blocks for sure. If SHP block is performed in patients who do not have epidural catheters, it can be useful to decrease postoperative pain scores and opioid or NSAID consumption significantly.

Eligibility criteria: Inclusion Criteria:

* ASA I - II
* Elective 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
timeFrame: postoperative 48 hour follow-up (PACU and ward)
measure: Postoperative Analgesic Consumption
timeFrame: postoperative 48 hour follow-up (PACU and ward)
Secondary outcomes:
measure: Rescue Analgesic Time
timeFrame: 48 hours (time to the first analgesic demand will be recorded)
measure: Duration of Operation
timeFrame: from the induction of anesthesia and the end of the surgery
measure: Length of Hospital Stay
timeFrame: assessed up to 1 week
measure: Number of Participants With Complications Due to SHP Block
timeFrame: From the SHP block time (intraoperative) until discharge
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 G. Aytuluk, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Derince Training and Research Hospital
name: Gulfem Basol, MD
role: STUDY_CHAIR
affiliation: Derince Training and Research Hospital
name: Ahmet Kale, Prof
role: STUDY_CHAIR
affiliation: Derince Training and Research Hospital
name: Canan Balci, Assoc Prof
role: STUDY_CHAIR
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citation: 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.
citation: 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.