Analgesia Clinical Trial
Official title:
The Effect of Epidural Analgesia and Erector Spinae Plane Block on Intraoperative and Early Postoperative Outcomes in Open Gynecological Oncological Surgeries: a Prospective Randomized Study
The aim of this study is to compare the effectiveness of epidural block or erector spinae plane block applied for postoperative analgesia in gynecological cancer surgeries. The main question(s) it aims to answer are: [Is erector spinae plane block as effective as epidural block in postoperative analgesia?] The study was designed as a prospective randomized study. Researchers evaluated the effects of epidural block or erector spinae plane block applied for postoperative analgesia on pain scores, postoperative opioid use, and mobilization in patients undergoing gynecological cancer surgery.
Status | Not yet recruiting |
Enrollment | 70 |
Est. completion date | January 31, 2025 |
Est. primary completion date | January 1, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 30 Years to 70 Years |
Eligibility | Inclusion Criteria: - Patients who will undergo open abdominal surgery - Patients with ASAII-III - Those between the ages of 30-70 - Patients who are fully oriented and able to cooperate Exclusion Criteria: - Patients with ASAIV-V - Presence of active infection in the area where the block will be applied - Patients younger than 30 years old - Patients with BMI > 40 - Patients who are allergic to bupivacaine - Chronic analgesic use |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Duygu Akyol |
Bisch SP, Jago CA, Kalogera E, Ganshorn H, Meyer LA, Ramirez PT, Dowdy SC, Nelson G. Outcomes of enhanced recovery after surgery (ERAS) in gynecologic oncology - A systematic review and meta-analysis. Gynecol Oncol. 2021 Apr;161(1):46-55. doi: 10.1016/j.y — View Citation
Chen LM, Weinberg VK, Chen C, Powell CB, Chen LL, Chan JK, Burkhardt DH 3rd. Perioperative outcomes comparing patient controlled epidural versus intravenous analgesia in gynecologic oncology surgery. Gynecol Oncol. 2009 Dec;115(3):357-61. doi: 10.1016/j.y — View Citation
Courtney-Brooks M, Tanner Kurtz KC, Pelkofski EB, Nakayama J, Duska LR. Continuous epidural infusion anesthesia and analgesia in gynecologic oncology patients: less pain, more gain? Gynecol Oncol. 2015 Jan;136(1):77-81. doi: 10.1016/j.ygyno.2014.10.015. E — View Citation
Ferguson SE, Malhotra T, Seshan VE, Levine DA, Sonoda Y, Chi DS, Barakat RR, Abu-Rustum NR. A prospective randomized trial comparing patient-controlled epidural analgesia to patient-controlled intravenous analgesia on postoperative pain control and recove — View Citation
Lin C, Gill R, Kumar K. [Bilateral lower thoracic erector spinae plane block in open abdominal gynecologic oncology surgery: a cases series]. Braz J Anesthesiol. 2019 Sep-Oct;69(5):517-520. doi: 10.1016/j.bjan.2019.03.011. Epub 2019 Oct 19. — View Citation
Nelson G, Fotopoulou C, Taylor J, Glaser G, Bakkum-Gamez J, Meyer LA, Stone R, Mena G, Elias KM, Altman AD, Bisch SP, Ramirez PT, Dowdy SC. Enhanced recovery after surgery (ERAS(R)) society guidelines for gynecologic oncology: Addressing implementation ch — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | postoperative mobilization time | The other purpose of this study is the first postoperative mobilization process | postoperatvely 24 hours | |
Primary | postoperative numerical rating scale | The primary purpose of this study is to compare NRS values at 0, 6, 12 and 24 hours in the first 24 hours postoperatively. Numeric rating scale was used to assess postoperative pain For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable. | postoperatvely 24 hours | |
Secondary | Intraoperative amount of remifentanyl | The secondary aim of this study is to compare the amount of intraoperative remifentanyl | intraoperative process |
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