Clinical trial NCT05672680: Transabdominal Plane (TAP) Blocks for Inguinal Hernia Repairs
Official title: Transabdominal Plane (TAP) Blocks for Inguinal Hernia Repairs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Inguinal Hernia
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2023-01-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this double-blind clinical trial is to examine outcomes and pain control after surgery in patients who underwent laparoscopic inguinal hernia repair (IHR) with the use of perioperative transabdominal plane (TAP) block.

Research Question: Does transabdominal plane block improve pain when undergoing inguinal hernia repair? The endpoints include whether preoperative TAP blocks improve pain score (primary end point) and decrease opioid use (secondary endpoint) after an inguinal hernia repair. Other end points- complications after surgery.

Detailed description: Protocol:

After receiving approval for the study, the researchers will conduct a prospective single institution randomized clinical trial assessing if using a TAP block perioperatively can reduce pain scores after surgery. Other endpoints include whether there are differences in pain medication usage and complications.

Patients will be screened by research team members and attending surgeons. If the patient is interested, the researchers will consent the participants for the study after understanding the study details, procedures, and expectations. The researchers will then consent using IRB approved study consent forms and procedures. Patients will undergo a laparoscopic inguinal hernia repair according to standard procedures. The study will assess if a TAP block impacts pain scores. Patients will be randomized to receive the intervention or placebo. Sequentially numbered sealed opaque envelopes with group allocation inside will alert the anesthesiologist \& surgeon to order Tap block composed of 0.25% bupivacaine or placebo (normal saline).

Inguinal hernia repair will be performed in standard fashion that each individual surgeon is familiar with. No additional tests or blood work outside the standard of care for IHR will be performed for research purposes. In addition, some patients will be given TAP blocks before surgery to help in pain management. Patients will be discharged with a worksheet on which the participants are to record analgesic use and pain scores on postoperative days one, two, three and four. The participants are expected to bring the completed log to their two-week follow up visit with their surgeon. Patients may also expect to receive a phone call from a member of the surgical team to remind them to record these metrics.

The TAP block is done pre-procedure using 0.25% bupivacaine. If patients weigh\<100 kg, the patients will receive a total of 50 ml (25 ml on each side of the abdominal wall). If patients weigh\>100 kg, the patients will receive a total of 60 ml (30ml on each side of the abdominal wall). The TAP plane is identified using ultrasound. All anesthesiologists (not surgeons) working with the attendings involved in this study have been trained in this technique; it is a routine part of their practice. It is anesthesiologists who will be performing the block.

Patients will be discharged with a worksheet /survey on which the patients are to record analgesic use and pain scores on postoperative days one, two, three and four. The patients are expected to bring the completed log to their two-week follow up visit.

Eligibility criteria: Inclusion Criteria:

- Patients undergoing laparoscopic inguinal hernia repair at the Mount Sinai Hospital

Exclusion Criteria:

* patients who are younger than 18 years old,
* have a history of chronic opiate usage, liver or kidney disease, pain syndromes,
* allergy to bupivacaine,
* are pregnant or
* are unable to independently give consent

Primary outcomes:
measure: Pain Score at Rest
timeFrame: on post-op days 1, 2, 3, and 4
measure: Pain Score at Rest
timeFrame: All post-op (average 4 days)
measure: Pain Score at Movement
timeFrame: on post-op days 1, 2, 3, and 4
measure: Pain Score at Movement
timeFrame: All post-op (average 4 days)
Secondary outcomes:
measure: Number of Opioid Pills
timeFrame: on post-op days 1, 2, 3, and 4
measure: Number of Opioid Pills
timeFrame: All post-op (average 4 days)
measure: Number of Non-opioid Pain Medication
timeFrame: on post-op days 1, 2, 3, and 4
measure: Number of Non-opioid Pain Medication
timeFrame: All post-op (average 4 days)
measure: Number of Intraoperative Complications
timeFrame: up to 2 weeks post-surgery
measure: Number of Participants With Contents in the Hernia
timeFrame: during procedure
measure: Number of Surgical Tacks Used Per Repair
timeFrame: during procedure
measure: Procedure Time
timeFrame: during procedure
measure: Number of Participants With Greater or Less Than 25 Milliliters Estimated Blood Loss
timeFrame: during procedure
measure: Number of Patients Per Anesthesiologist
timeFrame: during procedure
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Celia M Divino, MD
role: PRINCIPAL_INVESTIGATOR
References: