Sphenopalatine Ganglion Block to Prevent Shoulder Pain After Laparoscopic Bariatric Surgery
| Status: | Completed |
|---|---|
| Conditions: | Obesity Weight Loss, Orthopedic |
| Therapuetic Areas: | Endocrinology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 5/16/2018 |
| Start Date: | May 2016 |
| End Date: | March 16, 2018 |
The purpose of this study is to determine the efficacy of sphenopalatine ganglion (SPG) block
to prevent shoulder tip pain following primary laparoscopic gastric banding, band revision,
band replacement, primary sleeve gastrectomy or revision of sleeve gastrectomy. Shoulder tip
pain (STP) is a common problem after laparoscopic surgery, manifesting in the post-anesthesia
care unit and for days or possibly weeks thereafter (Dixon 2005). Systemic analgesics
including opioids and non-steroidal anti-inflammatory drugs (NSAIDs) do not reliably relieve
STP. This study is designed to determine if the SPG block, a simple and low-risk procedure,
effectively treats STP after laparoscopic bariatric surgery.
to prevent shoulder tip pain following primary laparoscopic gastric banding, band revision,
band replacement, primary sleeve gastrectomy or revision of sleeve gastrectomy. Shoulder tip
pain (STP) is a common problem after laparoscopic surgery, manifesting in the post-anesthesia
care unit and for days or possibly weeks thereafter (Dixon 2005). Systemic analgesics
including opioids and non-steroidal anti-inflammatory drugs (NSAIDs) do not reliably relieve
STP. This study is designed to determine if the SPG block, a simple and low-risk procedure,
effectively treats STP after laparoscopic bariatric surgery.
This is a randomized, placebo-controlled, parallel group prospective, double-blind study. The
primary outcome variable will be change in STP from > 4 before to after treatment in the PACU
after primary laparoscopic gastric banding, band revision, band replacement, sleeve
gastrectomy, or revision of sleeve gastrectomy. Investigators hope to achieve a decline in
STP in 2 units after treatment.
primary outcome variable will be change in STP from > 4 before to after treatment in the PACU
after primary laparoscopic gastric banding, band revision, band replacement, sleeve
gastrectomy, or revision of sleeve gastrectomy. Investigators hope to achieve a decline in
STP in 2 units after treatment.
Inclusion Criteria:
- Elective primary laparoscopic gastric banding surgery.
- Laparoscopic band revision surgery
- Laparoscopic band replacement surgery.
- Sleeve gastrectomy.
- Revision of sleeve gastrectomy.
- American Society of Anesthesiologists Class 2 or 3.
- No allergy to study drugs.
- Facility with English language to allow compliance with study protocol.
Exclusion Criteria:
- American Society of Anesthesiologists Class 4 or 5.
- Allergy to lidocaine or to any local anesthetic
- Allergy to oxymetazoline (Afrin)
- Pregnancy
- Bleeding diathesis
- Known nasal pathology including active sinusitis
- Previous nasal surgery
- Preoperative anticoagulant use OTHER THAN aspirin 81 mg and/or heparin 5000 U SQ bid
administered for DVT prophylaxis.
- Acute psychiatric disease
- History of chronic right or left shoulder pain
- Current opioid use
- Any patient that the study team feels will be unable to comply with all protocol
related procedures
- Concurrent participation in another clinical trial
We found this trial at
1
site
New York University School of Medicine NYU School of Medicine has a proud history that...
Click here to add this to my saved trials
