Inguinal Hernia
Conditions
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.
Interventions
received during TAP block
DRUGPlacebo
placebo equivalent
PROCEDURETAP 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.).
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score at Rest | 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. |
| Pain Score at Movement | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Number of Non-opioid Pain Medication | on post-op days 1, 2, 3, and 4 | Patients recorded the number of non-opioid pills taken for pain control. |
| 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. |
| Number of Patients Per Anesthesiologist | during procedure | The number of patients handled per anesthesiologist. |
| Procedure Time | during procedure | Procedure duration in minutes. |
| Number of Opioid Pills | on post-op days 1, 2, 3, and 4 | Patients recorded the number of opioid pills taken. |
Countries
United States
Participant flow
Recruitment details
Recruitment performed in outpatient office from 12/9/2019 to 07/23/2023.
Participants by arm
| Arm | Count |
|---|---|
| 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: placebo equivalent
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.). | 44 |
| 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.
0.25% Bupivacaine: received during TAP block
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.). | 46 |
| Total | 90 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Patient Did Not Complete the Form | 5 | 4 |
| Overall Study | Procedure Aborted | 1 | 0 |
Baseline characteristics
| Characteristic | Placebo | Experimental | Total |
|---|---|---|---|
| Age, Continuous | 58.07 years STANDARD_DEVIATION 13.67 | 56.42 years STANDARD_DEVIATION 15.78 | 57.24 years STANDARD_DEVIATION 14.71 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 3 Participants | 2 Participants | 5 Participants |
| Sex: Female, Male Male | 41 Participants | 44 Participants | 85 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 44 | 0 / 46 |
| other Total, other adverse events | 0 / 44 | 0 / 46 |
| serious Total, serious adverse events | 0 / 44 | 0 / 46 |
Outcome results
Primary
Pain Score at Movement
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Pain Score at Movement | post-op day 1 | 5.84 score on a scale | Standard Deviation 2.42 |
| Placebo | Pain Score at Movement | post-op day 2 | 5.47 score on a scale | Standard Deviation 2.56 |
| Placebo | Pain Score at Movement | post-op day 3 | 4.65 score on a scale | Standard Deviation 2.21 |
| Placebo | Pain Score at Movement | post-op day 4 | 3.71 score on a scale | Standard Deviation 2.37 |
| Experimental | Pain Score at Movement | post-op day 4 | 4.31 score on a scale | Standard Deviation 2.53 |
| Experimental | Pain Score at Movement | post-op day 1 | 6.35 score on a scale | Standard Deviation 2.54 |
| Experimental | Pain Score at Movement | post-op day 3 | 4.99 score on a scale | Standard Deviation 2.51 |
| Experimental | Pain Score at Movement | post-op day 2 | 6.16 score on a scale | Standard Deviation 2.55 |
Primary
Pain Score at Movement
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Pain Score at Movement | 4.93 score on a scale | Standard Deviation 2.51 |
| Experimental | Pain Score at Movement | 5.46 score on a scale | Standard Deviation 2.67 |
Primary
Pain Score at Rest
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Pain Score at Rest | post-op day 2 | 4.21 score on a scale | Standard Deviation 2.49 |
| Placebo | Pain Score at Rest | post-op day 4 | 2.92 score on a scale | Standard Deviation 2.39 |
| Placebo | Pain Score at Rest | post-op day 3 | 3.53 score on a scale | Standard Deviation 2.39 |
| Placebo | Pain Score at Rest | post-op day 1 | 4.31 score on a scale | Standard Deviation 2.46 |
| Experimental | Pain Score at Rest | post-op day 3 | 3.77 score on a scale | Standard Deviation 2.49 |
| Experimental | Pain Score at Rest | post-op day 2 | 4.53 score on a scale | Standard Deviation 2.61 |
| Experimental | Pain Score at Rest | post-op day 1 | 4.55 score on a scale | Standard Deviation 2.7 |
| Experimental | Pain Score at Rest | post-op day 4 | 3.19 score on a scale | Standard Deviation 2.46 |
Primary
Pain Score at Rest
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Pain Score at Rest | 3.75 score on a scale | Standard Deviation 2.48 |
| Experimental | Pain Score at Rest | 4.01 score on a scale | Standard Deviation 2.65 |
Secondary
Number of Intraoperative Complications
Chart review complications recorded. These are considered expected intraoperative complications and are not considered as adverse events based on research procedures.
Time frame: up to 2 weeks post-surgery
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Intraoperative Complications | Early Recurrence | 0 number of complications |
| Placebo | Number of Intraoperative Complications | Hematoma | 0 number of complications |
| Placebo | Number of Intraoperative Complications | Mortality | 0 number of complications |
| Placebo | Number of Intraoperative Complications | Urinary Retention | 1 number of complications |
| Placebo | Number of Intraoperative Complications | Induration | 1 number of complications |
| Experimental | Number of Intraoperative Complications | Induration | 1 number of complications |
| Experimental | Number of Intraoperative Complications | Early Recurrence | 1 number of complications |
| Experimental | Number of Intraoperative Complications | Urinary Retention | 2 number of complications |
| Experimental | Number of Intraoperative Complications | Hematoma | 1 number of complications |
| Experimental | Number of Intraoperative Complications | Mortality | 0 number of complications |
Secondary
Number of Non-opioid Pain Medication
Patients recorded the number of non-opioid pills taken for pain control.
Time frame: All post-op (average 4 days)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Number of Non-opioid Pain Medication | 0.86 number of pills | Standard Deviation 1.07 |
| Experimental | Number of Non-opioid Pain Medication | 0.73 number of pills | Standard Deviation 0.98 |
Secondary
Number of Non-opioid Pain Medication
Patients recorded the number of non-opioid pills taken for pain control.
Time frame: on post-op days 1, 2, 3, and 4
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Number of Non-opioid Pain Medication | post-op day 1 | 0.76 number of pills | Standard Deviation 1.03 |
| Placebo | Number of Non-opioid Pain Medication | post-op day 2 | 1.07 number of pills | Standard Deviation 1.22 |
| Placebo | Number of Non-opioid Pain Medication | post-op day 3 | 0.85 number of pills | Standard Deviation 1.04 |
| Placebo | Number of Non-opioid Pain Medication | post-op day 4 | 0.77 number of pills | Standard Deviation 0.98 |
| Experimental | Number of Non-opioid Pain Medication | post-op day 4 | 0.65 number of pills | Standard Deviation 0.82 |
| Experimental | Number of Non-opioid Pain Medication | post-op day 1 | 0.71 number of pills | Standard Deviation 1.09 |
| Experimental | Number of Non-opioid Pain Medication | post-op day 3 | 0.77 number of pills | Standard Deviation 0.96 |
| Experimental | Number of Non-opioid Pain Medication | post-op day 2 | 0.78 number of pills | Standard Deviation 1.05 |
Secondary
Number of Opioid Pills
Patients recorded the number of opioid pills taken.
Time frame: on post-op days 1, 2, 3, and 4
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Number of Opioid Pills | post-op day 1 | 1.29 number of pills | Standard Deviation 1.47 |
| Placebo | Number of Opioid Pills | post-op day 2 | 1.25 number of pills | Standard Deviation 1.62 |
| Placebo | Number of Opioid Pills | post-op day 3 | 0.88 number of pills | Standard Deviation 1.45 |
| Placebo | Number of Opioid Pills | post-op day 4 | 1.21 number of pills | Standard Deviation 1.54 |
| Experimental | Number of Opioid Pills | post-op day 4 | 0.77 number of pills | Standard Deviation 1.26 |
| Experimental | Number of Opioid Pills | post-op day 1 | 1.52 number of pills | Standard Deviation 1.28 |
| Experimental | Number of Opioid Pills | post-op day 3 | 0.60 number of pills | Standard Deviation 1.1 |
| Experimental | Number of Opioid Pills | post-op day 2 | 1.35 number of pills | Standard Deviation 1.48 |
Secondary
Number of Opioid Pills
Patients recorded the number of opioid pills taken.
Time frame: All post-op (average 4 days)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Number of Opioid Pills | 1.16 number of pills | Standard Deviation 1.52 |
| Experimental | Number of Opioid Pills | 1.06 number of pills | Standard Deviation 1.33 |
Secondary
Number of Participants With Contents in the Hernia
Number of participants with contents in the hernia, specifically bowel, lipoma, omentum, and bladder.
Time frame: during procedure
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Contents in the Hernia | Bowel | 1 Participants |
| Placebo | Number of Participants With Contents in the Hernia | Omentum | 0 Participants |
| Placebo | Number of Participants With Contents in the Hernia | Lipoma | 10 Participants |
| Placebo | Number of Participants With Contents in the Hernia | Bladder | 0 Participants |
| Placebo | Number of Participants With Contents in the Hernia | None | 33 Participants |
| Experimental | Number of Participants With Contents in the Hernia | Bladder | 0 Participants |
| Experimental | Number of Participants With Contents in the Hernia | None | 39 Participants |
| Experimental | Number of Participants With Contents in the Hernia | Bowel | 0 Participants |
| Experimental | Number of Participants With Contents in the Hernia | Lipoma | 6 Participants |
| Experimental | Number of Participants With Contents in the Hernia | Omentum | 1 Participants |
Secondary
Number of Participants With Greater or Less Than 25 Milliliters Estimated Blood Loss
Number of participants with greater or less than 25 milliliters estimated blood loss recorded during procedure.
Time frame: during procedure
Population: A participant was missing this data. This is due to human error for not inputting the information.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Greater or Less Than 25 Milliliters Estimated Blood Loss | Less than 25 milliliters | 38 Participants |
| Placebo | Number of Participants With Greater or Less Than 25 Milliliters Estimated Blood Loss | Greater than or equal to 25 milliliters | 5 Participants |
| Placebo | Number of Participants With Greater or Less Than 25 Milliliters Estimated Blood Loss | Data not collected | 1 Participants |
| Experimental | Number of Participants With Greater or Less Than 25 Milliliters Estimated Blood Loss | Less than 25 milliliters | 39 Participants |
| Experimental | Number of Participants With Greater or Less Than 25 Milliliters Estimated Blood Loss | Greater than or equal to 25 milliliters | 7 Participants |
| Experimental | Number of Participants With Greater or Less Than 25 Milliliters Estimated Blood Loss | Data not collected | 0 Participants |
Secondary
Number of Patients Per Anesthesiologist
The number of patients handled per anesthesiologist.
Time frame: during procedure
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Patients Per Anesthesiologist | Anesthesiologist 3 | 7 Participants |
| Placebo | Number of Patients Per Anesthesiologist | Anesthesiologist 2 | 3 Participants |
| Placebo | Number of Patients Per Anesthesiologist | Anesthesiologist 4 | 16 Participants |
| Placebo | Number of Patients Per Anesthesiologist | Anesthesiologist 1 | 18 Participants |
| Experimental | Number of Patients Per Anesthesiologist | Anesthesiologist 2 | 2 Participants |
| Experimental | Number of Patients Per Anesthesiologist | Anesthesiologist 1 | 21 Participants |
| Experimental | Number of Patients Per Anesthesiologist | Anesthesiologist 4 | 19 Participants |
| Experimental | Number of Patients Per Anesthesiologist | Anesthesiologist 3 | 4 Participants |
Secondary
Number of Surgical Tacks Used Per Repair
Number of tacks used in bilateral hernia surgery per repair. The more tacks used can be associated with increased pain.
Time frame: during procedure
Population: There were a number of participants that were missing this data. This is due to human error for not inputting the information.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Surgical Tacks Used Per Repair | 4 | 16 Participants |
| Placebo | Number of Surgical Tacks Used Per Repair | 5 | 0 Participants |
| Placebo | Number of Surgical Tacks Used Per Repair | 6 | 18 Participants |
| Placebo | Number of Surgical Tacks Used Per Repair | Data not collected | 10 Participants |
| Experimental | Number of Surgical Tacks Used Per Repair | Data not collected | 16 Participants |
| Experimental | Number of Surgical Tacks Used Per Repair | 4 | 12 Participants |
| Experimental | Number of Surgical Tacks Used Per Repair | 6 | 15 Participants |
| Experimental | Number of Surgical Tacks Used Per Repair | 5 | 3 Participants |
Secondary
Procedure Time
Procedure duration in minutes.
Time frame: during procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Procedure Time | 72.7 Minutes | Standard Deviation 19.13 |
| Experimental | Procedure Time | 78.54 Minutes | Standard Deviation 27.2 |