ObesityPhase 4NCT02809755
Sphenopalatine Ganglion Block to Prevent Shoulder Pain After Laparoscopic Bariatric Surgery
A Phase 4 study testing 4% Lidocaine and Saline in people with Obesity, run by NYU Langone Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity
- What is being tested?
- 4% Lidocaine and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2016to 3 Apr 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
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.
Read the 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
- Being tested
- 4% Lidocaine, Saline
- Keywords
- Obesity, laparoscopic gastric banding, band revision, laparoscopic gastric banding sleeve gastrectomy
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4% LidocaineDrug
SalineOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: Baseline, 30 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study start8 Aug 2016
- Primary completion3 Apr 2017
- Study completion3 Apr 2017
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gilbert Grant, Principal investigator, New York University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02809755
- Sponsor's protocol ID
- 15-01278
- Status last verified
- Apr 2019
- First submitted
- 20 Jun 2016
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sphenopalatine Ganglion Block to Prevent Shoulder Pain After Laparoscopic Bariatric Surgery
- ClinicalTrials.gov ID
- NCT02809755
- Acronym / sponsor ID
- 15-01278
- Conditions
- Obesity
- Keywords
- Obesity, laparoscopic gastric banding, band revision, laparoscopic gastric banding sleeve gastrectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason 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.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 8 Aug 2016
- Primary completion
- 3 Apr 2017 (actual)
- Study completion
- 3 Apr 2017 (actual)
- First posted
- 22 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4% lidocaine | Experimental | Drug: 4% Lidocaine10 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. |
| Placebo Saline | Placebo comparator | Other: Saline10 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Elective primary laparoscopic gastric banding surgery.
- Laparoscopic band revision surgery
- Laparoscopic band replacement surgery.
- Sleeve gastrectomy.
- Revision of sleeve gastrectomy.
Key exclusion criteria (13 listed)
- American Society of Anesthesiologists Class 4 or 5.
- Allergy to lidocaine or to any local anesthetic
- Allergy to oxymetazoline (Afrin)
- Pregnancy
- Bleeding diathesis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 4% Lidocaine | Drug | 4% lidocaine |
| Saline | Other | Placebo Saline |
Primary outcome
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."
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilbert Grant principal investigator
New York University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 4% Lidocaine and Saline in people with Obesity, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2019; AzTrials last refreshed its copy on 8 Nov 2026.