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.
