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Sphenopalatine Ganglion Block to Prevent Shoulder Pain After Laparoscopic Bariatric Surgery

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ClinicalTrials.gov Identifier: NCT02809755
Recruitment Status : Withdrawn (While 33 people signed consent, no one was enrolled in the study, because none of these patients developed shoulder pain in the recovery room.)
First Posted : June 22, 2016
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

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.

Condition or disease Intervention/treatment Phase
Obesity Drug: 4% Lidocaine Other: Saline Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Sphenopalatine Ganglion Block to Prevent Shoulder Pain After Laparoscopic Bariatric Surgery
Study Start Date : August 8, 2016
Actual Primary Completion Date : April 3, 2017
Actual Study Completion Date : April 3, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Drug: 4% Lidocaine
Placebo Comparator: 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.
Other: Saline



Primary Outcome Measures :
  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 [ Time Frame: Baseline, 30 Minutes ]
    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."



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02809755


Locations
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United States, New York
New York University School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Gilbert Grant New York University Medical School
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02809755    
Other Study ID Numbers: 15-01278
First Posted: June 22, 2016    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by NYU Langone Health:
Obesity
laparoscopic gastric banding
band revision
laparoscopic gastric banding sleeve gastrectomy
Additional relevant MeSH terms:
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Shoulder Pain
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action