Superior Hypogastric Plexus Blockade in Laparoscopic Hysterectomy

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

• Registration Number: NCT03427840
• Lead Sponsor: Derince Training and Research Hospital

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.

Study Timeline

• Study First Submitted: 2018-02-01
• Study First Submitted QC: 2018-02-03
• Study First Posted: 2018-02-09
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-17
• Study Start: 2018-03-18
• Last Update Posted: 2018-03-20
• Primary Completion: 2018-06-30
• Study Completion: 2018-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
postoperative pain scores (PACU)	1 hour (postoperatively)	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)
postoperative opioid/NSAID consumption (PACU)	1 hour (postoperatively)	nonsteroid antiinflammatory drugs (NSAID) or opioid drugs that are applied to patients will be noted down.
rescue analgesic time	48 hours (first analgesic demand time will be noted down)	Time to first analgesic demand at gynecology ward (after transfer from PACU to gynecology ward)
postoperative pain scores (ward)	48 hours (postoperatively)	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)
postoperative opioid/NSAID consumption (ward)	48 hours (total)	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Derince Training and Research Hospital; 🇹🇷 Kocaeli, Derince, Turkey