Tap Block vs Conventional Pain Medication for Patients Undergoing Robotic Sacrocolpopexy

Not Applicable

• Conditions: Prolapse; Prolapse; Vagina, Posthysterectomy; Anesthesia, Local; Prolapse; Female; Pain, Postoperative; Prolapse, Vaginal
• Interventions: Procedure: TAP block

• Registration Number: NCT04440475
• Lead Sponsor: ProMedica Health System

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.

Study Timeline

• Study First Submitted: 2020-06-17
• Study First Submitted QC: 2020-06-17
• Study First Posted: 2020-06-19
• Study Start: 2020-06-28
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-29
• Last Update Posted: 2021-11-30
• Primary Completion: 2022-01
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tap Block	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

Primary Outcome Measures

Name	Time	Method
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)
amount of postoperative oral pain medication	48 hours	amount of postoperative oral pain medication used by patient after surgery

Trial Locations

Locations (1)

Promedica Toledo Hospital; 🇺🇸 Toledo, Ohio, United States