Efficacy of Transversus Abdominis Plane Block

Anesthesia, Local Clinical Trial

Official title:

Efficacy of Transversus Abdominis Plane Block in an Insufflated Abdomen

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06274307
• Other study ID #: IRB-21-10-4045
• Status: Recruiting
• Phase: N/A
• Start date: June 22, 2023
• Est. completion date: September 1, 2024

Study information

• Verified date: February 2024
• Source: Wayne State University
• Contact: George M McKelvey, PhD
• Phone: 3135986036
• Email: gmckelve[@]dmc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to assess the efficacy of Transversus Abdominus Plane (TAP) blocks, a well-established anesthetic technique, to decrease the amount of post-operative pain in patients who undergo minimally invasive gynecologic surgeries. During minimally invasive gynecologic surgeries, the abdomen is inflated with pressurized air for visualization purposes and released at the end of the surgery. Traditionally, TAP blocks are performed by injecting long-acting local anesthetic agents under ultrasound guidance into the abdominal wall after abdominal surgery after the air has been emptied from the abdomen for additional anesthetic coverage post-operatively. This study proposes a novel approach: that performing TAP blocks while the abdomen is still insufflated will result in better post-operative pain outcomes as compared to the traditional method.

Description:

Background Every year 15 million laparoscopic procedures are performed globally, with 4,800,000 or 32% of procedures performed in the U.S. alone. This minimally invasive procedure is one of the most common surgical procedures in the United States. Approximately 350,000 or half of all bilateral tubal sterilizations are performed laparoscopically; almost two-thirds of the 600,000 hysterectomies are performed via laparoscopy. Laparoscopy is also commonly used for diagnostic purposes, and to perform other common procedures such as treatment for endometriosis and lysis of adhesions. During laparoscopic gynecologic surgeries, the surgical team will have the abdomen inflated with pressurized carbon dioxide for surgical visualization purposes which is then released at the end of the surgical procedure. For many laparoscopic procedures, a transversus abdominis plane block (TAP) block using a long-acting local anesthetic is used to manage pain performed outside the OR, more for logistical ease, traditionally this block is performed outside the operating room setting, in the post-operative period on a non- insufflated abdomen under ultrasound guidance. Rationale for conducting the research. This study has two major aims; 1) to determine whether post-operative TAP blocks performed in an insufflated abdomen will result in more optimal postoperative pain control compared to TAP blocks performed in the traditional method in a non-insufflated abdomen and 2) to observe if performing the TAP block in a insufflated abdomen will be more clinically efficient to perform than the traditional method performed in a non-insufflated abdomen. The study hypothesis is that the study group receiving the TAP block the insufflated abdomen will have more optimal postoperative pain control, requiring less adjuvant pain medication as compared to the participants receiving the control intervention. Additionally, we hypothesize that the proceduralist will be able to perform a TAP block in less time with and with few attempts in the insufflated compared to the non- insufflated abdomen group due to better visualization of the anatomical planes from insufflation of the abdominal area. The results of this study may add additional clinically effective practice guidelines for both regional anesthesia and acute pain management relating to laparoscopic gynecological procedures. Furthermore, TAP blocks performed under insufflation may provide a viable method for decreasing opioid use and reducing potential opioid dependence in patients following surgical intervention.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Female gynecological patients between 18 years and 85 years consented and scheduled for an obstetrics/gynecology laparoscopic procedure.
• Consent received to receive a TAP block.

Exclusion Criteria:

• Patients who are not proficient in the English language or cannot consent
• Patients who have an allergy to local anesthetics (amides)
• Patients with subcutaneous emphysema
• Patients whose surgical procedures require incisions above the umbilicus

Related Conditions & MeSH terms

• Anesthesia, Local

Intervention

Procedure:
• Transversus abdominis plane block
A transversus abdominis plane block (TAP) block using a long-acting local anesthetic is used to manage pain during the intermediate (12-24hr) post-operative period following laparoscopic abdominal surgeries. Drug: The local anesthetic to be used in this specific intervention will be 30 to 40ml of Ropivacaine 0.375%, not to exceed a max dose of 3mg/kg of 0.375% and divided equally bilaterally.

Locations

Country	Name	City	State
United States	Detroit Medical Center Detroit Receiving Hospital	Detroit	Michigan
United States	Detroit Medical Center, Harper University Hospital	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Justin Hruska

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to perform TAP Block	Time taken to successfully perform the TAP block. Defined as the time from initial placement of ultrasound probe on the skin to the completion of the block on the contralateral side.	Within 10 minutes of starting procedure.
Primary	TAP block attempts	The number of attempts taken to sucessfully perform the TAP block.	Within 10 minutes of starting procedure.
Primary	Pain Score Visual Analog Scale (VAS) 0 Hours Post Surgery	Pain score on an 11-point (0 - no pain to 10 - worst imaginable pain) Visual Analog Scale (VAS) at rest	0 hours following TAP block]
Primary	Pain Score Visual Analog Scale (VAS) 1 Hours Post Surgery	Pain score on an 11-point (0 - no pain to 10 - worst imaginable pain) Visual Analog Scale (VAS) at rest	1 hour following TAP block]
Primary	Pain Score Visual Analog Scale (VAS) 2 Hours Post Surgery	Pain score on an 11-point (0 - no pain to 10 - worst imaginable pain) Visual Analog Scale (VAS) at rest	2 hours following TAP block]
Primary	Pain Score Visual Analog Scale (VAS) 4 Hours Post Surgery	Pain score on an 11-point (0 - no pain to 10 - worst imaginable pain) Visual Analog Scale (VAS) at rest	4 hours following TAP block]
Primary	Pain Score Visual Analog Scale (VAS) 24 Hours Post Surgery	Pain score on an 11-point (0 - no pain to 10 - worst imaginable pain) Visual Analog Scale (VAS) at rest	24 hours following TAP block]
Primary	Postoperative Opioid Consumption	Patient opioid consumption in the 24 hours post TAP block	24 hours post operative period
Primary	Ease of performing TAP Block-anatomical plane visualization	The anatomical planes were clearly visualized and identified. Survey of operator - Likert Score	Within 10 minutes of starting procedure
Primary	Ease of performing TAP Block-performance efficacy	The approach optimized the efficacy of the block. Survey of operator- Likert score	Within 10 minutes of starting procedure
Primary	Patient satisfaction	Patient satisfaction with analgesia score (0 to 100%)	24-hours post operative period