Laparoscopic Sleeve Gastrectomy, Subcostal Transversus Abdominis Plane Block
Conditions
Keywords
Randomized control trial, Subcostal transversus abdominis plane block, Laparoscopic sleeve gastrectomy, Regional anesthesia, Opioid consumption, Bariatrics
Brief summary
The study team will be assessing if the unilateral subcostal transversus abdominis plane (TAP) block can decrease pain and improve outcomes following laparoscopic sleeve gastrectomy surgeries.
Detailed description
This study will be a double-blinded randomized control trial. Patients will be randomized into one of two groups. Patients in Group 1 will undergo general anesthesia with a post-induction, post-intubation, pre-procedural subcostal TAP block with 40 mL 0.25% bupivacaine on the ipsilateral side as the extraction site. Patients in Group 2 will undergo general anesthesia with a post-induction, post-intubation, pre-procedural subcostal TAP block with 40 mL sterile normal saline on the ipsilateral side as the extraction site. Investigators will be blinded to the randomization of these patients. Following performance of these blocks, patients will receive standard care for the surgery as well as during the postoperative recovery period. Data will be obtained from the EPIC electronic medical record, and from the anesthesia computer record. Patients will be asked postoperatively to assess items such as their nausea and pain scores. Patients will also be contacted by phone within 1-2 days of discharge to obtain analgesic satisfaction scores. This data will be collected on the Redcap server.
Interventions
DRUGSaline
40 mL sterile normal saline
DRUGBupivacaine
40 mL 0.25% bupivacaine
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Group allocation and instructions on preparing the injectate solution for the subcostal TAP block will be included in a sealed envelope. On the day of the surgery, the group allocation will be revealed to an anesthesiologist not involved with the research study. The anesthesiologist not involved in the study or the care of the patient will prepare the solution to be used for the subcostal TAP block.
Intervention model description
The study consists of two study arms. Patients will be getting a subcostal transversus abdominis plane block with either bupivacaine or saline.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Adults 18-80 years old * Candidate for general anesthesia * Undergoing laparoscopic sleeve gastrectomy * Patients of participating surgeons
Exclusion criteria
* Prior bariatric surgery of any kind * Previous abdominoplasty * Allergy or intolerance to one of the study medications * ASA \> 4 * Chronic opioid use (taking opioids for longer than 3 months or daily oral morphine equivalent of \>5mg/day for one month) * History of alcohol/drug abuse * History of hepatic or renal insufficiency * Patient refusal
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amount of 24 Hour Opioid Consumption | 24 Hours postoperative | Amount of intravenous (IV) opioid consumption within 24-hour period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Amount of Intraoperative IV Opioid Consumption | average 2-3 Hours | Amount of intravenous opioid consumption during the surgery |
| Number of Participants Asked Area of Pain on the Body After Surgery | 24 Hours postoperative | Patients asked for the areas of pain (right upper quadrant (RUQ), left upper quadrant, (LUQ) right lower quadrant (RLQ), or left lower quadrant (LLQ), diffuse and epigastric) after surgery. |
| Number of Participants Who Answered Yes to Having Presence of Nausea After Surgery | 24 Hours postoperative | Number of participants who answered yes to having presence of nausea after surgery |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Saline Patients underwent general anesthesia with a post-induction, post-intubation, pre-procedural subcostal TAP block with normal saline on the ipsilateral side as the extraction site.
Saline: 40 mL sterile normal saline | 21 |
| Bupivacaine Patients underwent general anesthesia with a post-induction, post-intubation, pre-procedural subcostal TAP block with bupivacaine on the ipsilateral side as the extraction site.
Bupivacaine: 40 mL 0.25% bupivacaine | 19 |
| Total | 40 |
Baseline characteristics
| Characteristic | Saline | Bupivacaine | Total |
|---|---|---|---|
| Age, Continuous | 40 years | 36 years | 36.5 years |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 9 Participants | 16 Participants | 25 Participants |
| Sex: Female, Male Male | 12 Participants | 3 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 20 |
| other Total, other adverse events | 0 / 23 | 0 / 20 |
| serious Total, serious adverse events | 0 / 23 | 0 / 20 |
Outcome results
Primary
Amount of 24 Hour Opioid Consumption
Amount of intravenous (IV) opioid consumption within 24-hour period
Time frame: 24 Hours postoperative
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Saline | Amount of 24 Hour Opioid Consumption | 44.7 morphine milligram equivalents |
| Bupivacaine | Amount of 24 Hour Opioid Consumption | 38.7 morphine milligram equivalents |
Secondary
Amount of Intraoperative IV Opioid Consumption
Amount of intravenous opioid consumption during the surgery
Time frame: average 2-3 Hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Saline | Amount of Intraoperative IV Opioid Consumption | 35 morphine milligram equivalents |
| Bupivacaine | Amount of Intraoperative IV Opioid Consumption | 32.5 morphine milligram equivalents |
Secondary
Number of Participants Asked Area of Pain on the Body After Surgery
Patients asked for the areas of pain (right upper quadrant (RUQ), left upper quadrant, (LUQ) right lower quadrant (RLQ), or left lower quadrant (LLQ), diffuse and epigastric) after surgery.
Time frame: 24 Hours postoperative
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Saline | Number of Participants Asked Area of Pain on the Body After Surgery | RUQ | 3 Participants |
| Saline | Number of Participants Asked Area of Pain on the Body After Surgery | RLQ | 0 Participants |
| Saline | Number of Participants Asked Area of Pain on the Body After Surgery | diffuse | 7 Participants |
| Saline | Number of Participants Asked Area of Pain on the Body After Surgery | LLQ | 0 Participants |
| Saline | Number of Participants Asked Area of Pain on the Body After Surgery | LUQ | 1 Participants |
| Saline | Number of Participants Asked Area of Pain on the Body After Surgery | epigastric | 7 Participants |
| Saline | Number of Participants Asked Area of Pain on the Body After Surgery | none | 3 Participants |
| Bupivacaine | Number of Participants Asked Area of Pain on the Body After Surgery | epigastric | 6 Participants |
| Bupivacaine | Number of Participants Asked Area of Pain on the Body After Surgery | none | 7 Participants |
| Bupivacaine | Number of Participants Asked Area of Pain on the Body After Surgery | diffuse | 1 Participants |
| Bupivacaine | Number of Participants Asked Area of Pain on the Body After Surgery | RUQ | 3 Participants |
| Bupivacaine | Number of Participants Asked Area of Pain on the Body After Surgery | LUQ | 2 Participants |
| Bupivacaine | Number of Participants Asked Area of Pain on the Body After Surgery | RLQ | 0 Participants |
| Bupivacaine | Number of Participants Asked Area of Pain on the Body After Surgery | LLQ | 0 Participants |
Secondary
Number of Participants Who Answered Yes to Having Presence of Nausea After Surgery
Number of participants who answered yes to having presence of nausea after surgery
Time frame: 24 Hours postoperative
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Saline | Number of Participants Who Answered Yes to Having Presence of Nausea After Surgery | 16 Participants |
| Bupivacaine | Number of Participants Who Answered Yes to Having Presence of Nausea After Surgery | 14 Participants |