Efficacy of Transversus Abdominis Plane Block

NCT ID: NCT06274307

Last Updated: 2025-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-22
• Study Completion Date: 2025-03-01

Brief 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.

Detailed 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.

Conditions

Anesthesia, Local

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Active Comparator: Transversus abdominis plane (TAP) block performed in operating room

The treatment group will have a transversus abdominis plane (TAP) block performed prior to closing surgical port sites post-operatively in an insufflated abdomen in the operating room (OR). The local anesthetic used for the TAP block will be 30 to 40ml of Ropivacaine 0.375%, not to exceed a max dose of 3mg/kg of 0.375% divided equally bilaterally. Each study participant will receive standard post-operative pain medication orders of morphine 2mg q5mins times 4 doses followed by hydromorphone. 0.5mg q10mins times 4 doses.

Group Type: ACTIVE_COMPARATOR

Transversus abdominis plane block

Intervention Type: PROCEDURE

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.

Transversus abdominis plane (TAP) block performed in PACU

The treatment group will have a transversus abdominis plane (TAP) block performed post-operatively after the patient has been transferred from the Operating Room to the Post Anesthesia Care Unit (PACU). The local anesthetic used for the TAP block will be 30 to 40ml of Ropivacaine 0.375%, not to exceed a max dose of 3mg/kg of 0.375% divided equally bilaterally. Each study participant will receive standard post-operative pain medication orders of morphine 2mg q5mins times 4 doses followed by hydromorphone. 0.5mg q10mins times 4 doses

Group Type: ACTIVE_COMPARATOR

Transversus abdominis plane block

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Justin Hruska

OTHER

Sponsor Role: lead

Responsible Party

Justin Hruska

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Justin Hruska, MD

Role: PRINCIPAL_INVESTIGATOR

Wayne State University/Detroit Medical Center

Locations

Detroit Medical Center Detroit Receiving Hospital

Detroit, Michigan, United States

Detroit Medical Center, Harper University Hospital

Detroit, Michigan, United States

Countries

United States

Other Identifiers

IRB-21-10-4045

Identifier Type: -

Identifier Source: org_study_id