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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

Tracking Information
First Submitted Date February 1, 2018
First Posted Date February 9, 2018
Last Update Posted Date March 20, 2018
Actual Study Start Date March 18, 2018
Estimated Primary Completion Date June 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 3, 2018)
  • 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)
  • 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.
  • 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)
  • 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)
  • 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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03427840 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: February 3, 2018)
  • 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
  • length of stay [ Time Frame: 3-5 days (expected) ]
    length of hospital stay time will be noted
  • 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,.. )
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Superior Hypogastric Plexus Blockade in Laparoscopic Hysterectomy
Official Title Efficacy of Intraoperative Superior Hypogastric Plexus Blockade for Postoperative Pain in Laparoscopic Hysterectomy
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The patients who are scheduled for elective laparoscopic hysterectomy under general anesthesia.
Condition
  • Superior Hypogastric Plexus Block
  • Hysterectomy
  • Minimally Invasive Surgery
  • Laparoscopy
  • Pain, Postoperative
  • Gynecologic Disease
Intervention Procedure: Procedure/Surgery: superior hypogastric block
superior hypogastric blockade during surgery
Study Groups/Cohorts
  • Hypo
    The participants with a superior hypogastric block
    Intervention: Procedure: Procedure/Surgery: 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 retroperitone is opened intraoperatively by the surgeon)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 3, 2018)
60
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 1, 2018
Estimated Primary Completion Date June 30, 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: patients who are scheduled for hysterectomy
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Hande Aytuluk, MD +902623198000 handegrbz@gmail.com
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT03427840
Other Study ID Numbers U1111-1208-8608
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: The investigators do not prefer to share the study plan and records.
Responsible Party Hande G. Aytuluk, Derince Training and Research Hospital
Study Sponsor Derince Training and Research Hospital
Collaborators Not Provided
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
PRS Account Derince Training and Research Hospital
Verification Date March 2018