Tap Block vs Conventional Pain Medication for Patients Undergoing Robotic Sacrocolpopexy (SACROTAP)

Tap Block vs Conventional Pain Medication for Patients Undergoing Robotic Sacrocolpopexy, a Pilot Study

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.

Study Overview

• Status: Recruiting
• Conditions: Pain, Postoperative; Anesthesia, Local; Prolapse; Prolapse; Female; Prolapse, Vaginal; Prolapse; Vagina, Posthysterectomy
• Intervention / Treatment: Procedure: TAP block

Detailed Description

Sacrocolpopexy is a procedure to correct prolapse of the vaginal apex (top of the vagina) in women who have had a previous hysterectomy. The operation is designed to restore the vagina to its normal position and function. Pain management is an important aspect of perioperative anesthetic care. Acute postoperative pain control impacting surgical outcomes remains a controversial topic

The transversus abdominis plane (TAP) block was first presented by Rafi in 2001 as a landmark-guided technique via the triangle of Petit to achieve a field block. It involves the injection of a local anesthetic between the internal oblique muscle and transversus abdominis muscle. The thoracolumbar nerves originating from the T6 to L1 spinal roots run into this plane and supply sensory nerves to the anterolateral abdominal wall, the local anesthetic in this plane can block the neural afferents and provide analgesia to the anterolateral abdominal wall. The Tap block is a widely used procedure to help in postoperative pain management, it is easily performed, cost-effective, with minimal procedure-related morbidity. The use of Tap block is in concordance with several of the goals of Enhanced Recovery After Surgery Pathways (ERAS). In a systematic review comparing Tap bloc to no tap block for post-hysterectomy pain found that visual analog score (VAS) was lower in patients receiving tap block in both open and laparoscopic hysterectomy procedures. The study found no significant difference in the amount of morphine used by patients who underwent laparoscopic hysterectomy and received a tap block. Currently the standard of care at Promedica hospitals is to give patients oral medications to control postop pain after sacrocolpopexy. Patients are offered to receive a tap block or no, and it is up to the patient to receive the tap block or no.

No Studies on Tap block after Sacrocolpopexy have been published yet. Our hypothesis is that Tap block will reduce the need for pain meds during the first 24 to 48 hours after sacrocolpopexy.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dani Zoorob, MD; Phone Number: 4192913125; Email: dani.zoorobmd@promedica.org
• Study Contact Backup: Name: Ibrahim Tsolakian, MD; Phone Number: 2485679262; Email: ibrahim.tsolakian@utoledo.edu

Study Locations

• United States
  • Ohio
    • Toledo, Ohio, United States, 43606
      • Recruiting
      • ProMedica Toledo Hospital
      • Contact: Dani Zoorob, MD
      • Contact: Ibrahim Tsolakain, MD; Phone Number: 2485679262; Email: ibrahim.tsolakian@utoledo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tap Block; 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; 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.
No Intervention: Conventional postoperative oral medication; postoperative conventional oral medication as needed: Acetaminophen 650 mg Q 6 hours Ibuprofen 600 mg Q 6 hours Tramadol 50 mg Q 6 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: ProMedica Health System
• Investigators: Principal Investigator: Dani Zoorob, MD, ProMedica Health System

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2020
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: June 17, 2020
• First Submitted That Met QC Criteria: June 17, 2020
• First Posted (Actual): June 19, 2020

Study Record Updates

• Last Update Posted (Actual): November 30, 2021
• Last Update Submitted That Met QC Criteria: November 29, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Uterine Diseases; Pathological Conditions, Anatomical; Pelvic Organ Prolapse; Pain, Postoperative; Prolapse; Uterine Prolapse
• Other Study ID Numbers: 20-068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Individual participant data (IPD) will not be shared with other researchers, data will be destroyed 3 years after study completion

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No