Mount Sinai Hospital
New York, 10029, United States
NCT Number: NCT05672680
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 2 / Phase 3
New York, 10029, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
received during TAP block
placebo equivalent
The intervention is a transabdominal plane (TAP) block given in the abdomen to block pain receptors on nerves -during surgery can presumably decrease postoperative pain. Currently, TAP blocks are approved for use and performed based on surgeon preference (e.g. some surgeons perform them on every case, others variably, etc.).
Time frame: on post-op days 1, 2, 3, and 4
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.
Time frame: 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.
Time frame: on post-op days 1, 2, 3, and 4
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.
Time frame: 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.
Time frame: on post-op days 1, 2, 3, and 4
Patients recorded the number of opioid pills taken.
Time frame: All post-op (average 4 days)
Patients recorded the number of opioid pills taken.
Time frame: on post-op days 1, 2, 3, and 4
Patients recorded the number of non-opioid pills taken for pain control.
Time frame: All post-op (average 4 days)
Patients recorded the number of non-opioid pills taken for pain control.
Time frame: 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.
Time frame: during procedure
Number of participants with contents in the hernia, specifically bowel, lipoma, omentum, and bladder.
Time frame: during procedure
Number of tacks used in bilateral hernia surgery per repair. The more tacks used can be associated with increased pain.
Time frame: during procedure
Procedure duration in minutes.
Time frame: during procedure
Number of participants with greater or less than 25 milliliters estimated blood loss recorded during procedure.
Time frame: during procedure
The number of patients handled per anesthesiologist.
Icahn School of Medicine at Mount Sinai
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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