Superior Hypogastric Plexus Blockade in Laparoscopic Hysterectomy

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03427840
• Other study ID #: U1111-1208-8608
• Status: Recruiting
• First received: February 1, 2018
• Last updated: March 17, 2018
• Start date: March 18, 2018
• Est. completion date: July 1, 2018

Study information

• Verified date: March 2018
• Source: Derince Training and Research Hospital
• Contact: Hande Aytuluk, MD
• Phone: +902623198000
• Email: handegrbz[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 1, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Genital Diseases, Female
• Gynecologic Disease
• Hysterectomy
• Laparoscopy
• Minimally Invasive Surgery
• Pain, Postoperative
• Superior Hypogastric Plexus Block

Intervention

Procedure:
• Procedure/Surgery: superior hypogastric block
superior hypogastric blockade during surgery

Locations

Country	Name	City	State
Turkey	Derince Training and Research Hospital	Kocaeli	Derince

Sponsors (1)

Lead Sponsor	Collaborator
Derince Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View 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. Review. — View 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. Review. — View 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 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	postoperative opioid/NSAID consumption (PACU)	nonsteroid antiinflammatory drugs (NSAID) or opioid drugs that are applied to patients will be noted down.	1 hour (postoperatively)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	length of stay	length of hospital stay time will be noted	3-5 days (expected)
Secondary	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)