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

Primary Purpose

Anesthesia, Local, Prolapse, Prolapse; Female

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TAP block
Sponsored by
ProMedica Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anesthesia, Local

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Promedica Toledo HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Tap Block

Conventional postoperative oral medication

Arm Description

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

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

Outcomes

Primary Outcome Measures

amount of postoperative oral pain medication
amount of postoperative oral pain medication used by patient after surgery
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)

Secondary Outcome Measures

Full Information

First Posted
June 17, 2020
Last Updated
November 29, 2021
Sponsor
ProMedica Health System
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1. Study Identification

Unique Protocol Identification Number
NCT04440475
Brief Title
Tap Block vs Conventional Pain Medication for Patients Undergoing Robotic Sacrocolpopexy
Acronym
SACROTAP
Official Title
Tap Block vs Conventional Pain Medication for Patients Undergoing Robotic Sacrocolpopexy, a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
June 28, 2020 (Actual)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
June 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ProMedica Health System

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Local, Prolapse, Prolapse; Female, Prolapse, Vaginal, Prolapse; Vagina, Posthysterectomy, Pain, Postoperative

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantInvestigator
Masking Description
The patient and the person performing the analysis will be masked
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tap Block
Arm Type
Experimental
Arm Description
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
Arm Title
Conventional postoperative oral medication
Arm Type
No Intervention
Arm Description
postoperative conventional oral medication as needed: Acetaminophen 650 mg Q 6 hours Ibuprofen 600 mg Q 6 hours Tramadol 50 mg Q 6 hours
Intervention Type
Procedure
Intervention Name(s)
TAP block
Intervention Description
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.
Primary Outcome Measure Information:
Title
amount of postoperative oral pain medication
Description
amount of postoperative oral pain medication used by patient after surgery
Time Frame
48 hours
Title
Numeric Rating Scale (NRS) scale improvement
Description
Numeric rating scale for pain will be assessed (0-10: 0 being no pain, 10 being the worst pain possible)
Time Frame
48 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dani Zoorob, MD
Phone
4192913125
Email
dani.zoorobmd@promedica.org
First Name & Middle Initial & Last Name or Official Title & Degree
Ibrahim Tsolakian, MD
Phone
2485679262
Email
ibrahim.tsolakian@utoledo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dani Zoorob, MD
Organizational Affiliation
ProMedica Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Promedica Toledo Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dani Zoorob, MD
First Name & Middle Initial & Last Name & Degree
Ibrahim Tsolakain, MD
Phone
2485679262
Email
ibrahim.tsolakian@utoledo.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data (IPD) will not be shared with other researchers, data will be destroyed 3 years after study completion
Citations:
PubMed Identifier
25580086
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.
Results Reference
background
PubMed Identifier
11576144
Citation
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.
Results Reference
background
PubMed Identifier
18428988
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.
Results Reference
background
PubMed Identifier
28742435
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.
Results Reference
background
PubMed Identifier
29723644
Citation
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.
Results Reference
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Tap Block vs Conventional Pain Medication for Patients Undergoing Robotic Sacrocolpopexy

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