Tap Block vs Conventional Pain Medication for Patients Undergoing Robotic Sacrocolpopexy

NCT04440475 | Completed

• 1 other identifier: 20-068
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anesthesia, Local; Prolapse; Prolapse; Female; Prolapse, Vaginal; Prolapse; Vagina, Posthysterectomy; Pain, Postoperative

Outcome Measures

Primary Outcomes (2)

• amount of postoperative oral pain medication

  amount of postoperative oral pain medication used by patient after surgery

  48 hours

• 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

Study Arms (2)

Tap Block

EXPERIMENTAL

TAP block at the end of the surgery, in addition to conventional postoperative oral medication as needed postoperative conventional oral medication as needed: Acetaminophen 650 mg Q 6 hours Ibuprofen 600 mg Q 6 hours Tramadol 50 mg Q 6 hours

Procedure: TAP block

Conventional postoperative oral medication

NO INTERVENTION

postoperative conventional oral medication as needed: Acetaminophen 650 mg Q 6 hours Ibuprofen 600 mg Q 6 hours Tramadol 50 mg Q 6 hours

Interventions

TAP block PROCEDURE

Tap block description: The skin is prepped and draped in a sterile fashion for a lateral to posterior/lateral approach to the Transverse Abdominis Plane (TAP). The Anesthesiologists use ultrasound guidance for all TAP blocks and pre mix 60cc of 0.2% ropivicaine with 10mg of preservative free dexamethasone. After the plane is identified in approximately the mid axillary line, a 17g Tuohy needle is used under ultrasound guidance to enter the potential space from an anterior approach. The needle is visualized in-plane with the ultrasound probe, traversing the exterior and interior oblique muscles and penetrating through the posterior fascia of internal oblique into the transverse abdominal plane. Once the Tuohy is in place, the needle is aspirated and the plane is hydro-dissected using 0.2% Ropivicaine with 10mg of dexamethasone. The anesthesiologist will use 30ml of 0.2% Ropivicaine on each side.

Tap Block

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ProMedica Health System: lead

Study Sites (1)

Promedica Toledo Hospital

Toledo, Ohio, 43606, United States

Location

Related Publications (6)

• 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.

  PMID: 25580086 BACKGROUND

• Rafi AN. Abdominal field block: a new approach via the lumbar triangle. Anaesthesia. 2001 Oct;56(10):1024-6. doi: 10.1046/j.1365-2044.2001.02279-40.x. No abstract available.

  PMID: 11576144 BACKGROUND

• 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.

  PMID: 18428988 BACKGROUND

• 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.

  PMID: 28742435 BACKGROUND

• 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.

  PMID: 29723644 BACKGROUND

• Zoorob D, Tsolakian I, Shuffle E, Perring P, Maxwell R. Addition of Transversus Abdominis Plane Block to Conventional Pain Regimens in Robotic Sacrocolpopexy Procedures-A Pilot Randomized Controlled Trial (SACROTAP). Urogynecology (Phila). 2023 Feb 1;29(2):139-143. doi: 10.1097/SPV.0000000000001287.

  PMID: 36735426 DERIVED

MeSH Terms

Conditions

Prolapse; Uterine Prolapse; Pain, Postoperative

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pelvic Organ Prolapse; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Dani Zoorob, MD

  ProMedica Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The patient and the person performing the analysis will be masked
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The investigators will perform a pilot randomized control trial, where one group will be receiving TAP blocks whereas the other group will be receiving regular postoperative pain medications (acetaminophen, ibuprofen, tramadol orally upon discharge). Randomization will be completed using a computer-generated randomization sequence using 1:1 ratio with blocking in groups of 4. The randomization sequence will kept in our research office and investigators enrolling subjects will not have access. Sequentially numbered sealed opaque envelopes will be prepared following the randomization sequence, randomized participants will receive an envelope in sequential order. The patient and the person performing the statistical analyses will be blinded.

Study Record Dates

• First Submitted: June 17, 2020
• First Posted: June 19, 2020
• Study Start: June 28, 2020
• Primary Completion: August 30, 2021
• Study Completion: January 30, 2022
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)