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

Sponsor

ProMedica Health System (Other)

Overall Status

Recruiting

CT.gov ID

NCT04440475

Collaborator

(none)

Enrollment

Location

Arms

23.1

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia, Local Prolapse Prolapse; Female Prolapse, Vaginal Prolapse; Vagina, Posthysterectomy Pain, Postoperative	Procedure: TAP block	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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:

Double (Participant, Investigator)

Masking Description:

The patient and the person performing the analysis will be masked

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jun 28, 2020

Anticipated Primary Completion Date :

Jan 1, 2022

Anticipated Study Completion Date :

Jun 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

amount of postoperative oral pain medication [48 hours]
amount of postoperative oral pain medication used by patient after surgery
Numeric Rating Scale (NRS) scale improvement [48 hours]
Numeric rating scale for pain will be assessed (0-10: 0 being no pain, 10 being the worst pain possible)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Promedica Toledo Hospital	Toledo	Ohio	United States	43606

Sponsors and Collaborators

ProMedica Health System

Investigators

Principal Investigator: Dani Zoorob, MD, ProMedica Health System

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

ProMedica Health System

ClinicalTrials.gov Identifier:

NCT04440475

Other Study ID Numbers:

20-068

First Posted:

Jun 19, 2020

Last Update Posted:

Nov 30, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Uterine Prolapse

Prolapse

Pain, Postoperative

Study Results

No Results Posted as of Nov 30, 2021