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Sphenopalatine Ganglion Block to Prevent Shoulder Pain After Laparoscopic Bariatric Surgery

Primary Purpose

Obesity

Status

Withdrawn

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

4% Lidocaine

Saline

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, laparoscopic gastric banding, band revision, laparoscopic gastric banding sleeve gastrectomy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

New York University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

4% lidocaine

Placebo Saline

Arm Description

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.

Outcomes

Primary Outcome Measures

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."

Secondary Outcome Measures

Full Information

NCT ID

NCT02809755

First Posted

June 20, 2016

Last Updated

April 16, 2019

Sponsor

NYU Langone Health

1. Study Identification

Unique Protocol Identification Number

NCT02809755

Brief Title

Sphenopalatine Ganglion Block to Prevent Shoulder Pain After Laparoscopic Bariatric Surgery

Official Title

Sphenopalatine Ganglion Block to Prevent Shoulder Pain After Laparoscopic Bariatric Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Withdrawn

Why Stopped

While 33 people signed consent, no one was enrolled in the study, because none of these patients developed shoulder pain in the recovery room.

Study Start Date

August 8, 2016 (undefined)

Primary Completion Date

April 3, 2017 (Actual)

Study Completion Date

April 3, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

4% lidocaine

Arm Type

Experimental

Arm Description

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.

Arm Title

Placebo Saline

Arm Type

Placebo Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

4% Lidocaine

Intervention Type

Other

Intervention Name(s)

Saline

Primary Outcome Measure Information:

Title

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

Description

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."

Time Frame

Baseline, 30 Minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gilbert Grant

Organizational Affiliation

New York University Medical School

Official's Role

Principal Investigator

Facility Information:

Facility Name

New York University School of Medicine

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

12. IPD Sharing Statement

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Sphenopalatine Ganglion Block to Prevent Shoulder Pain After Laparoscopic Bariatric Surgery

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