Transabdominal Plane (TAP) Blocks for Inguinal Hernia Repairs
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: 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. |
Drug: Placebo
placebo equivalent
Procedure: TAP block
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.).
|
| Experimental: Experimental 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. |
Drug: 0.25% Bupivacaine
received during TAP block
Procedure: TAP block
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.).
|
Outcome Measures
Primary Outcome Measures
- Pain Score [on post-op days 1-4]
On the "pain score" instrument, patients will score their pain score at rest and on movement. The full scale is score between 1-10, with higher score indicating more pain.
Secondary Outcome Measures
- Number of opioid pills [on post-op days 1-4]
Patients will record the number of opioid pills taken.
- Number of non-opioid pain medication [on post-op days 1-4]
Patients will record the number of non-opioid pills taken for pain control.
- Number of Complications [up to 2 weeks post-surgery]
Through chart review, complications (morbidity and mortality) will be recorded.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mount Sinai Hospital | New York | New York | United States | 10029 |
Sponsors and Collaborators
- Icahn School of Medicine at Mount Sinai
Investigators
- Principal Investigator: Celia M Divino, MD, Icahn School of Medicine at Mount Sinai
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY-19-00677