TAP Block for Local Anesthesia

Recruiting at 1 trial location

Overseen By Justin Hruska, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Justin Hruska

Disqualifiers: Allergy to anesthetics, Emphysema, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

106 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Justin Hruska, MD

Principal Investigator

Wayne State University/Detroit Medical Center

Eligibility Criteria

This trial is for patients undergoing minimally invasive gynecologic surgeries. Participants should be those who require post-operative pain management and are suitable candidates for receiving a Transversus Abdominis Plane (TAP) block, which is an anesthesia technique.

Inclusion Criteria

I have agreed to receive a TAP block.

I am a woman aged 18-85, scheduled for a gynecological laparoscopic procedure.

Exclusion Criteria

Patients who are not proficient in the English language or cannot consent

Patients who have an allergy to local anesthetics (amides)

My surgery involved cuts above my belly button.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo minimally invasive gynecologic surgeries with TAP blocks performed either in the operating room or in the PACU

1 day

1 visit (in-person)

Immediate Post-operative Monitoring

Participants are monitored for pain and ease of performing TAP block within 10 minutes post-surgery

10 minutes

Follow-up

Participants are monitored for pain scores and opioid consumption up to 24 hours post-surgery

24 hours

Treatment Details

Interventions

• Transversus Abdominis Plane Block

Trial Overview The study tests if performing TAP blocks while the abdomen is inflated with air during surgery leads to better pain control after surgery compared to the traditional method of doing it after deflation.

Participant Groups

Group I: Active Comparator: Transversus abdominis plane (TAP) block performed in operating room Active Control 1 Intervention

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 II: Transversus abdominis plane (TAP) block performed in PACU Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Justin Hruska

Lead Sponsor

Trials

1

Recruited

110+