Pain, Postoperative Clinical Trial
— SACROTAPOfficial title:
Tap Block vs Conventional Pain Medication for Patients Undergoing Robotic Sacrocolpopexy, a Pilot Study
NCT number | NCT04440475 |
Other study ID # | 20-068 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 28, 2020 |
Est. completion date | June 2022 |
The purpose of this study is to assess whether the transversus abdominis plane block (Tap block) is different than the oral postoperative pain medications in controlling pain after robotic sacrocolpopexy.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | June 2022 |
Est. primary completion date | January 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adults 18 years of age or older - Planning for surgical treatment of Pelvic Organ Prolapse (POP) with robotic sacrocolpopexy and rectocele repair under general anesthesia - Patient undergoing concurrent hysterectomy and/or sub-urethral sling will be included Exclusion Criteria: - Pregnant or nursing - Allergy to ropivicaine - History of drug/alcohol abuse - Severe cardiovascular, hepatic, renal disease, or neurological impairment Long-acting opioid use within 3 days or any opioid use within 24 hours before surgery - Contraindication to: acetaminophen, tramadol, non-steroidal anti- inflammatory drugs (NSAID) - Administration of an investigational drug within 30 days before study - Chronic pain syndromes - Daily NSAID/opioid use - Patients not undergoing general anesthesia - Patients undergoing concurrent transvaginal mesh removal, anal sphincteroplasty, or fistula repair |
Country | Name | City | State |
---|---|---|---|
United States | Promedica Toledo Hospital | Toledo | Ohio |
Lead Sponsor | Collaborator |
---|---|
ProMedica Health System |
United States,
Bacal V, Rana U, McIsaac DI, Chen I. Transversus Abdominis Plane Block for Post Hysterectomy Pain: A Systematic Review and Meta-Analysis. J Minim Invasive Gynecol. 2019 Jan;26(1):40-52. doi: 10.1016/j.jmig.2018.04.020. Epub 2018 Apr 30. — View Citation
Kim AJ, Yong RJ, Urman RD. The Role of Transversus Abdominis Plane Blocks in Enhanced Recovery After Surgery Pathways for Open and Laparoscopic Colorectal Surgery. J Laparoendosc Adv Surg Tech A. 2017 Sep;27(9):909-914. doi: 10.1089/lap.2017.0337. Epub 2017 Jul 25. Review. — View Citation
Rafi AN. Abdominal field block: a new approach via the lumbar triangle. Anaesthesia. 2001 Oct;56(10):1024-6. — View Citation
Rozen WM, Tran TM, Ashton MW, Barrington MJ, Ivanusic JJ, Taylor GI. Refining the course of the thoracolumbar nerves: a new understanding of the innervation of the anterior abdominal wall. Clin Anat. 2008 May;21(4):325-33. doi: 10.1002/ca.20621. Review. — View Citation
Yu N, Long X, Lujan-Hernandez JR, Succar J, Xin X, Wang X. Transversus abdominis-plane block versus local anesthetic wound infiltration in lower abdominal surgery: a systematic review and meta-analysis of randomized controlled trials. BMC Anesthesiol. 2014 Dec 15;14:121. doi: 10.1186/1471-2253-14-121. eCollection 2014. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | amount of postoperative oral pain medication | amount of postoperative oral pain medication used by patient after surgery | 48 hours | |
Primary | Numeric Rating Scale (NRS) scale improvement | Numeric rating scale for pain will be assessed (0-10: 0 being no pain, 10 being the worst pain possible) | 48 hours |
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