Sphenopalatine Ganglion Block to Prevent Shoulder Pain After Laparoscopic Bariatric Surgery

NCT ID: NCT02809755

Last Updated: 2019-04-18

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-08
• Study Completion Date: 2017-04-03

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

4% lidocaine

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.

Group Type: EXPERIMENTAL

4% Lidocaine

Intervention Type: DRUG

Placebo Saline

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.

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: OTHER

Interventions

4% Lidocaine

Intervention Type: DRUG

Saline

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gilbert Grant

Role: PRINCIPAL_INVESTIGATOR

New York University Medical School

Locations

New York University School of Medicine

New York, New York, United States

Countries

United States

Other Identifiers

15-01278

Identifier Type: -

Identifier Source: org_study_id