Sphenopalatine Ganglion Block to Prevent Shoulder Pain After Laparoscopic Bariatric Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Sphenopalatine Ganglion Block to Prevent Shoulder Pain After Laparoscopic Bariatric Surgery

Conditions
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Obesity

Intervention / Treatment
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* Drug: 4% Lidocaine
* Other: Saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 4% lidocaine<br>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. | Drug: 4% Lidocaine<br> <br> |
| Placebo Comparator: Placebo Saline<br>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. | Other: Saline<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | subject will be asked to rate her/his pain from zero to ten with zero being no pain to ten being the worst pain imaginable. | Baseline, 30 Minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, laparoscopic gastric banding, band revision, laparoscopic gastric banding sleeve gastrectomy