Sphenopalatine Ganglion Block to Prevent Shoulder Pain After Laparoscopic Bariatric Surgery

Obesity Clinical Trial

Official title:

Sphenopalatine Ganglion Block to Prevent Shoulder Pain After Laparoscopic Bariatric Surgery

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02809755
• Other study ID #: 15-01278
• Status: Withdrawn
• Phase: Phase 4
• Start date: August 8, 2016
• Est. completion date: April 3, 2017

Study information

• Verified date: April 2019
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 3, 2017
• Est. primary completion date: April 3, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Shoulder Pain

Intervention

Drug:
• 4% Lidocaine

Other:
• Saline

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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