Sphenopalatine Ganglion Block to Prevent Shoulder Pain After Laparoscopic Bariatric Surgery

NCT02809755 | Withdrawn Phase 4 DMC FDA Drug

• 1 other identifier: 15-01278
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Obesity; laparoscopic gastric banding; band revision; laparoscopic gastric banding sleeve gastrectomy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

4% lidocaine

EXPERIMENTAL

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

Placebo Saline

PLACEBO COMPARATOR

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

Interventions

4% Lidocaine DRUG

4% lidocaine

Saline OTHER

Placebo Saline

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Lidocaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Gilbert Grant

  New York University Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2016
• First Posted: June 22, 2016
• Study Start: August 8, 2016
• Primary Completion: April 3, 2017
• Study Completion: April 3, 2017
• Last Updated: April 18, 2019

Record last verified: 2019-04

Locations

US (1)