NCT04101019

Brief Summary

This is a prospective double blinded randomized pilot trial to evaluate the efficacy of phenopalatine ganglion block (SPGB) block to manage shoulder tip pain (STP) after laparoscopic surgery. Patients undergoing laparoscopic surgery will be approached by a member of the research team and those found eligible for participating will be enrolled after signing an informed consent form. Patients will be randomized to have the SPGB block with saline versus active drug which contains 10% lidocaine diluted to 5%. The block will be performed , by an experienced member of the research team, and the patient will then be followed up by the investigator for any adverse events and levels of shoulder pain.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
23 days until next milestone

First Posted

Study publicly available on registry

September 24, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

September 24, 2019

Status Verified

July 1, 2019

Enrollment Period

1 year

First QC Date

July 8, 2019

Last Update Submit

September 22, 2019

Conditions

Nerve Block

Outcome Measures

Primary Outcomes (1)

  • A numerical rate score decrease in shoulder pain

    90 minutes following performing the SPGB

Study Arms (2)

Control

PLACEBO COMPARATOR

The patient will undergo the SPGB block with saline.

Drug: Saline Solution

Active drug

ACTIVE COMPARATOR

The patient will undergo the SPGB block with the active drug which will include 10% lidocaine diluted to 5%.

Drug: Lidocaine

Interventions

LidocaineDRUG

Intervention will include the SPGB block which will be performed by placing the patient supine with the neck extended and 1.5 ml of 5% lidocaine will be dripped into one or two nostrils.

Active drug
Saline SolutionDRUG

Intervention will include the SPGB block which will be performed by placing the patient supine with the neck extended and 1.5 ml of saline will be dripped into one or two nostrils.

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any type of gynecologic, urologic, thoracic, bariatric and general surgical procedures
  • Presence of post-operative STP, VAS \> 4/10
  • American Society of Anesthesiologists Class 1 - 3

You may not qualify if:

  • American Society of Anesthesiologists Class 4 or 5.
  • Allergy to lidocaine.
  • Any patient who the PI feels will be unable to comply with all protocol related procedures
  • Shoulder pain prior to surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beilinson hospital

Petach Tikvah, Israel

Location

Related Publications (4)

  • Barre F. Cocaine as an abortive agent in cluster headache. Headache. 1982 Mar;22(2):69-73. doi: 10.1111/j.1526-4610.1982.hed2202069.x. No abstract available.

    PMID: 7085264BACKGROUND

  • Berger JJ, Pyles ST, Saga-Rumley SA. Does topical anesthesia of the sphenopalatine ganglion with cocaine or lidocaine relieve low back pain? Anesth Analg. 1986 Jun;65(6):700-2. No abstract available.

    PMID: 2871775BACKGROUND

  • Grant GJ, Echevarria GC, Lax J, Pass HI, Oshinsky ML. Sphenopalatine Ganglion Block to Treat Shoulder Tip Pain After Thoracic Surgery: Report of 2 Cases. A A Pract. 2018 Aug 15;11(4):90-92. doi: 10.1213/XAA.0000000000000746.

    PMID: 29634542BACKGROUND

  • Tsai HW, Wang PH, Yen MS, Chao KC, Hsu TF, Chen YJ. Prevention of postlaparoscopic shoulder and upper abdominal pain: a randomized controlled trial. Obstet Gynecol. 2013 Mar;121(3):526-531. doi: 10.1097/AOG.0b013e318283fcca.

    PMID: 23635614BACKGROUND

MeSH Terms

Interventions

LidocaineSaline Solution

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Central Study Contacts

Sharon Orbach-Zinger, MD

CONTACT

054-5383093sharonorbach@yahoo.com

Atara Davis, BA

CONTACT

0533321329ataratdavis@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Double blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2019

First Posted

September 24, 2019

Study Start

September 1, 2019

Primary Completion

September 1, 2020

Study Completion

December 1, 2020

Last Updated

September 24, 2019

Record last verified: 2019-07

Locations

IL(1)