Clinical trial NCT02809755: Sphenopalatine Ganglion Block to Prevent Shoulder Pain After Laparoscopic Bariatric Surgery
Official title: Sphenopalatine Ganglion Block to Prevent Shoulder Pain After Laparoscopic Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Obesity
Keywords: Obesity
laparoscopic gastric banding
band revision
laparoscopic gastric banding sleeve gastrectomy
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-06-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in STP as assessed by Numeric Rating Scale (NRS-11), from before to after the treatment in the PACU after receiving a 30-minute unilateral SPG block or bilateral SPG block
timeFrame: Baseline, 30 Minutes
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York University Medical School
name: Gilbert Grant
role: PRINCIPAL_INVESTIGATOR
References: