Superior Hypogastric Blockade for Postoperative Pain

NCT03428152 | Completed Results

• 1 other identifier: U1111-1205-2226
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Superior Hypogastric Plexus Block; Hysterectomy; Pain, Postoperative; Gynecologic Disease

Keywords

superior hypogastric plexus block; hysterectomy; postoperative pain

Outcome Measures

Primary Outcomes (2)

• Postoperative Pain Scores

  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) (PACU: Post-anesthesia care unit) VAS-PACU: VAS scores at PACU VAS 1: VAS scores at postoperative 1st hour (ward) VAS 6: VAS scores at postoperative 6th hour (ward) VAS 12: VAS scores at postoperative 12th hour (ward) VAS 24: VAS scores at postoperative 24th hour (ward) VAS 48: VAS scores at postoperative 48th hour (ward)

  postoperative 48 hour follow-up (PACU and ward)

• Postoperative Analgesic Consumption

  Total number of non-steroid anti-inflammatory drug (NSAID) and opioid vials that are applied to patients in post-anesthesia care unit (PACU) and at ward will be recorded. Target VAS score for NSAID is \>4; if there is no response to NSAID and pain is worsening opioid drugs will be applied (this is our routine clinical practice) NSAID: Diclofenac sodium 75mg per vial; opioid: Tramadol 100mg per vial.

  postoperative 48 hour follow-up (PACU and ward)

Secondary Outcomes (4)

• Rescue Analgesic Time

  48 hours (time to the first analgesic demand will be recorded)

• Duration of Operation

  from the induction of anesthesia and the end of the surgery

• Length of Hospital Stay

  assessed up to 1 week

• Number of Participants With Complications Due to SHP Block

  From the SHP block time (intraoperative) until discharge

Study Arms (2)

Hypo

The participants with a superior hypogastric block

Procedure: superior hypogastric block

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 retro-peritoneum is opened intraoperatively by the surgeon)

Interventions

superior hypogastric block PROCEDURE

superior hypogastric blockade during surgery

Hypo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: patients who are scheduled for hysterectomy
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• ASA I - II
• Elective hysterectomy

You may not qualify if:

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

Sponsors & Collaborators

• Derince Training and Research Hospital: lead

Study Sites (1)

Derince Training and Research Hospital

Kocaeli, Derince, 41900, Turkey (Türkiye)

Location

Related Publications (8)

• Plancarte R, de Leon-Casasola OA, El-Helaly M, Allende S, Lema MJ. Neurolytic superior hypogastric plexus block for chronic pelvic pain associated with cancer. Reg Anesth. 1997 Nov-Dec;22(6):562-8.

  PMID: 9425974 BACKGROUND

• de Leon-Casasola OA, Kent E, Lema MJ. Neurolytic superior hypogastric plexus block for chronic pelvic pain associated with cancer. Pain. 1993 Aug;54(2):145-151. doi: 10.1016/0304-3959(93)90202-Z.

  PMID: 8233527 BACKGROUND

• 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.

  PMID: 27208713 BACKGROUND

• Choi JW, Kim WH, Lee CJ, Sim WS, Park S, Chae HB. The Optimal Approach for a Superior Hypogastric Plexus Block. Pain Pract. 2018 Mar;18(3):314-321. doi: 10.1111/papr.12603. Epub 2017 Jul 6.

  PMID: 28520297 BACKGROUND

• Turker G, Basagan-Mogol E, Gurbet A, Ozturk C, Uckunkaya N, Sahin S. A new technique for superior hypogastric plexus block: the posteromedian transdiscal approach. Tohoku J Exp Med. 2005 Jul;206(3):277-81. doi: 10.1620/tjem.206.277.

  PMID: 15942158 BACKGROUND

• 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.

  PMID: 12945023 BACKGROUND

• 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.

  PMID: 27292167 RESULT

• 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.

  PMID: 31567396 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Genital Diseases, Female

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Results Point of Contact

• Title: Dr
• Organization: Derince Training and Research Hospital

handegrbz@gmail.com

+905336515650

Study Officials

• Hande G. Aytuluk, MD

  Derince Training and Research Hospital

  PRINCIPAL INVESTIGATOR

• Gulfem Basol, MD

  Derince Training and Research Hospital

  STUDY CHAIR

• Ahmet Kale, Prof

  Derince Training and Research Hospital

  STUDY CHAIR

• Canan Balci, Assoc Prof

  Derince Training and Research Hospital

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Principal investigator

Study Record Dates

• First Submitted: January 30, 2018
• First Posted: February 9, 2018
• Study Start: February 9, 2018
• Primary Completion: July 23, 2018
• Study Completion: July 24, 2018
• Last Updated: March 13, 2024
• Results First Posted: June 3, 2019

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)