Transabdominal Plane (TAP) Blocks for Inguinal Hernia Repairs
Overview
- Phase
- Phase 2
- Intervention
- Placebo
- Conditions
- Inguinal Hernia
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Pain Score at Rest
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Celia M. Divino
The Edelman Professor of Surgery
Icahn School of Medicine at Mount Sinai
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
Arms & Interventions
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.
Intervention: 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.
Intervention: TAP block
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.
Intervention: 0.25% Bupivacaine
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.
Intervention: TAP block
Outcomes
Primary Outcomes
Pain Score at Rest
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.
Pain Score at Movement
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.
Secondary Outcomes
- Number of Patients Per Anesthesiologist(during procedure)
- Number of Opioid Pills(All post-op (average 4 days))
- Number of Non-opioid Pain Medication(All post-op (average 4 days))
- Number of Intraoperative Complications(up to 2 weeks post-surgery)
- Number of Participants With Contents in the Hernia(during procedure)
- Number of Surgical Tacks Used Per Repair(during procedure)
- Procedure Time(during procedure)
- Number of Participants With Greater or Less Than 25 Milliliters Estimated Blood Loss(during procedure)