Trials / Completed
CompletedNCT03856788
Unilateral TAP Block for Laparoscopic Gastric Sleeve Surgery
Effect of Unilateral Ultrasound-Guided Subcostal Transversus Abdominis Plane Block in Patients Undergoing Laparoscopic Sleeve Gastrectomy
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 43 (actual)
- Sponsor
- Icahn School of Medicine at Mount Sinai · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Saline | 40 mL sterile normal saline |
| DRUG | Bupivacaine | 40 mL 0.25% bupivacaine |
Timeline
- Start date
- 2018-12-10
- Primary completion
- 2021-03-25
- Completion
- 2021-03-25
- First posted
- 2019-02-27
- Last updated
- 2022-10-17
- Results posted
- 2022-10-17
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03856788. Inclusion in this directory is not an endorsement.