Clinical trial NCT04440475: Tap Block vs Conventional Pain Medication for Patients Undergoing Robotic Sacrocolpopexy
Official title: Tap Block vs Conventional Pain Medication for Patients Undergoing Robotic Sacrocolpopexy, a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia, Local
Prolapse
Prolapse; Female
Prolapse, Vaginal
Prolapse; Vagina, Posthysterectomy
Pain, Postoperative
Lead sponsor: ProMedica Health System
Sponsor class: OTHER
First posted: 2020-06-19
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: amount of postoperative oral pain medication
timeFrame: 48 hours
measure: Numeric Rating Scale (NRS) scale improvement
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Toledo
country: United States
facility: Promedica Toledo Hospital
state: Ohio
Study officials:
affiliation: ProMedica Health System
name: Dani Zoorob, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.