Pain, Postoperative Clinical Trial
Official title:
Efficacy of Intraoperative Superior Hypogastric Plexus Blockade for Postoperative Pain in Laparoscopic Hysterectomy
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.
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Derince Training and Research Hospital | Kocaeli | Derince |
Lead Sponsor | Collaborator |
---|---|
Derince Training and Research Hospital |
Turkey,
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
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) |
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