Sphenopalatine Ganglion Block to Prevent Shoulder Pain After Laparoscopic Bariatric Surgery

NYU Langone Health

Status and phase: Withdrawn; Phase 4

Conditions: Obesity

Treatments: Other: Saline; Drug: 4% Lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02809755

15-01278

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

4% lidocaine

Experimental group

Description:

10 mL vials filled with 4% lidocaine or normal saline (50 vials of each solution) and pharmacist will code the vials from 1 to 100 using a computer-generated randomization scheme.

Treatment:

Drug: 4% Lidocaine

Placebo Saline

Placebo Comparator group

Description:

10 mL vials filled with 4% lidocaine or normal saline (50 vials of each solution) and pharmacist will code the vials from 1 to 100 using a computer-generated randomization scheme.

Treatment:

Other: Saline