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Superior Hypogastric Plexus Blockade in Laparoscopic Hysterectomy

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ClinicalTrials.gov Identifier: NCT03427840
Recruitment Status : Recruiting
First Posted : February 9, 2018
Last Update Posted : March 20, 2018
Sponsor:
Information provided by (Responsible Party):
Hande G. Aytuluk, 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.

Condition or disease Intervention/treatment
Superior Hypogastric Plexus Block Hysterectomy Minimally Invasive Surgery Laparoscopy Pain, Postoperative Gynecologic Disease Procedure: Procedure/Surgery: superior hypogastric block

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 Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Efficacy of Intraoperative Superior Hypogastric Plexus Blockade for Postoperative Pain in Laparoscopic Hysterectomy
Actual Study Start Date : March 18, 2018
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : July 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy

Group/Cohort Intervention/treatment
Hypo
The participants with a superior hypogastric block
Procedure: Procedure/Surgery: superior hypogastric block
superior hypogastric blockade during surgery

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 retroperitone is opened intraoperatively by the surgeon)



Primary Outcome Measures :
  1. postoperative pain scores (PACU) [ Time Frame: 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)

  2. postoperative opioid/NSAID consumption (PACU) [ Time Frame: 1 hour (postoperatively) ]
    nonsteroid antiinflammatory drugs (NSAID) or opioid drugs that are applied to patients will be noted down.

  3. rescue analgesic time [ Time Frame: 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)

  4. postoperative pain scores (ward) [ Time Frame: 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)

  5. postoperative opioid/NSAID consumption (ward) [ Time Frame: 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 :
  1. Intraoperative hemodynamics [ Time Frame: 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

  2. length of stay [ Time Frame: 3-5 days (expected) ]
    length of hospital stay time will be noted

  3. complications due to SHP block [ Time Frame: 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,.. )



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   patients who are scheduled for hysterectomy
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The patients who are scheduled for elective laparoscopic hysterectomy under general anesthesia.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03427840


Contacts
Contact: Hande Aytuluk, MD +902623198000 handegrbz@gmail.com

Locations
Turkey
Derince Training and Research Hospital Recruiting
Kocaeli, Derince, Turkey, 41900
Contact: Hande G. Aytuluk, MD    +90 533 651 56 50    handegrbz@gmail.com   
Contact: Gulfem Basol, MD    +90 530 140 23 20    glfem412010@hotmail.com   
Principal Investigator: Hande G. Aytuluk, MD         
Sub-Investigator: Gulfem Basol, MD         
Sub-Investigator: Ahmet Kale, Prof         
Sponsors and Collaborators
Derince Training and Research Hospital
Investigators
Principal Investigator: Hande Aytuluk, MD Derince Training and Research Hospital
Study Chair: Ahmet Kale, Prof Derince Training and Research Hospital
Study Chair: Gulfem Basol, MD Derince Training and Research Hospital

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hande G. Aytuluk, M.D., Principal investigator, Derince Training and Research Hospital
ClinicalTrials.gov Identifier: NCT03427840     History of Changes
Other Study ID Numbers: U1111-1208-8608
First Posted: February 9, 2018    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The investigators do not prefer to share the study plan and records.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hande G. Aytuluk, Derince Training and Research Hospital:
Superior Hypogastric Plexus Block
Hysterectomy
Minimally invasive surgery
Laparoscopy
Pain
Gynecologic Disease

Additional relevant MeSH terms:
Pain, Postoperative
Genital Diseases, Female
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms