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Clinical Trials/NCT04101019
NCT04101019UnknownNot Applicable

Sphenopalatine Ganglion Block to Treat Shoulder Pain After Laparoscopic Surgery: A Prospective, Randomized, Double Blinded Trial

Rabin Medical Center1 site in 1 country76 target enrollmentStarted: September 2019Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Enrollment
76
Locations
1
Primary Endpoint
A numerical rate score decrease in shoulder pain

Study Overview

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.

Detailed Description

Purpose of the Study The purpose of this pilot study is to evaluate the efficacy of sphenopalatine ganglion block (SPGB) block to manage shoulder tip pain (STP) after laparoscopic surgery.

Background The laparoscopic technique has increasingly become a popular approach for many gynecologic, urologic, thoracic, bariatric and general surgical procedures. While laparoscopic surgery results in less postoperative pain than traditional open surgical techniques, it is associated with three distinct types of postoperative pain: incisional, visceral, and shoulder. The pain experienced in the shoulder is referred from irritation of the diaphragm and is referred to as shoulder tip pain (STP) to differentiate it from pain that originates in the shoulder. STP may persist for longer than incisional and visceral pain and may be the most difficult to treat. Narcotic and non-narcotic analgesics have only limited success in relieving STP, but none of these reliably eliminates STP, and they may be associated with undesirable systemic side effects. Recently the SPGB has been described as a means of managing STP (Grant 2018).

The SPGB was originally described more than 100 years ago as a treatment for headache (Sluder 1908). Since it was first described, the SPGB has been touted to relieve many types of pain, primarily of the head, but also pain extending down to the lower back (Berger 1986).

The SPG is located in pterygopalatine fossa adjacent to the sphenopalatine foramen. It is posterior to the middle nasal turbinate and separated from the nasal cavity by as little as 2 mm of mucosa. The proximity of the SPG to the nasal cavity facilitates renders it accessible to local anesthetic block. When local anesthetic is applied to the posterior nasopharyngeal mucosa, drug diffuses into the SPG and inhibits nerve conduction. The local anesthetic can be administered by injection, via a cotton-tipped applicator, or by simply dripping it into the nose when the patient is positioned with neck extension (Barre 1982).

Study Design This will be a randomized controlled trial to treat STP with local anesthetic or placebo in after laparoscopic surgery. The primary outcome variable will be reduction of STP.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Masking Description

Double blinded

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

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

Arms & Interventions

Control

Placebo Comparator

The patient will undergo the SPGB block with saline.

Intervention: Saline Solution (Drug)

Active drug

Active Comparator

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

Intervention: Lidocaine (Drug)

Outcomes

Primary Outcomes

A numerical rate score decrease in shoulder pain

Time Frame: 90 minutes following performing the SPGB

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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