Sphenopalatine Ganglion Block to Prevent Shoulder Pain After Laparoscopic Bariatric Surgery

Withdrawn before enrolling · Phase 4 · Has a placebo group

Conditions studied: Obesity

In brief

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.

Key facts

Study ID

NCT02809755

Run by

NYU Langone Health

People needed

0

Starts

2016-08-08

Expected to finish

2017-04-03

Last updated by the study team

2019-04-18

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• New York University School of Medicine — New York, New York, United States

Full record on ClinicalTrials.gov

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