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
|Condition or disease||Intervention/treatment|
|Superior Hypogastric Plexus Block Hysterectomy Minimally Invasive Surgery Laparoscopy Pain, Postoperative Gynecologic Disease||Procedure: Procedure/Surgery: superior hypogastric block|
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|
|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|
The participants with a superior hypogastric block
Procedure: Procedure/Surgery: superior hypogastric block
superior hypogastric blockade during surgery
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)
- 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
- 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,.. )
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
|Contact: Hande Aytuluk, MDfirstname.lastname@example.org|
|Derince Training and Research Hospital||Recruiting|
|Kocaeli, Derince, Turkey, 41900|
|Contact: Hande G. Aytuluk, MD +90 533 651 56 50 email@example.com|
|Contact: Gulfem Basol, MD +90 530 140 23 20 firstname.lastname@example.org|
|Principal Investigator: Hande G. Aytuluk, MD|
|Sub-Investigator: Gulfem Basol, MD|
|Sub-Investigator: Ahmet Kale, Prof|
|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|