Transabdominal Plane (TAP) Blocks for Inguinal Hernia Repairs

Phase 2

Completed

Conditions: Inguinal Hernia

Interventions: Drug: Placebo
Drug: 0.25% Bupivacaine
Procedure: TAP block

Registration Number: NCT05672680

Lead Sponsor: Icahn School of Medicine at Mount Sinai

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 100

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Normal Saline: For patients weighing \<100 kg, a total of 50 ml ((25 ml on each side of the abdominal wall) will be received. If patients weigh\>100 kg, a total of 60 ml (30ml on each side of the abdominal wall) will be received.
Placebo	TAP block	Normal Saline: For patients weighing \<100 kg, a total of 50 ml ((25 ml on each side of the abdominal wall) will be received. If patients weigh\>100 kg, a total of 60 ml (30ml on each side of the abdominal wall) will be received.
Experimental	0.25% Bupivacaine	0.25% bupivacaine: For patients weighing \<100 kg, a total of 50 ml ((25 ml on each side of the abdominal wall) will be received. If patients weigh\>100 kg, a total of 60 ml (30ml on each side of the abdominal wall) will be received.
Experimental	TAP block	0.25% bupivacaine: For patients weighing \<100 kg, a total of 50 ml ((25 ml on each side of the abdominal wall) will be received. If patients weigh\>100 kg, a total of 60 ml (30ml on each side of the abdominal wall) will be received.

Primary Outcome Measures

Name	Time	Method
Pain Score at Rest	All post-op (average 4 days)	On the pain score instrument, patients will score their pain score at rest. The full scale is scored between 1-10, with higher score indicating more pain.
Pain Score at Movement	All post-op (average 4 days)	On the pain score instrument, patients will score their pain score at movement. The full scale is scored between 1-10, with higher score indicating more pain.

Secondary Outcome Measures

Name	Time	Method
Number of Patients Per Anesthesiologist	during procedure	The number of patients handled per anesthesiologist.
Number of Opioid Pills	All post-op (average 4 days)	Patients recorded the number of opioid pills taken.
Number of Non-opioid Pain Medication	All post-op (average 4 days)	Patients recorded the number of non-opioid pills taken for pain control.
Number of Intraoperative Complications	up to 2 weeks post-surgery	Chart review complications recorded. These are considered expected intraoperative complications and are not considered as adverse events based on research procedures.
Number of Participants With Contents in the Hernia	during procedure	Number of participants with contents in the hernia, specifically bowel, lipoma, omentum, and bladder.
Number of Surgical Tacks Used Per Repair	during procedure	Number of tacks used in bilateral hernia surgery per repair. The more tacks used can be associated with increased pain.
Procedure Time	during procedure	Procedure duration in minutes.
Number of Participants With Greater or Less Than 25 Milliliters Estimated Blood Loss	during procedure	Number of participants with greater or less than 25 milliliters estimated blood loss recorded during procedure.