NCT00927888

Brief Summary

The aim of the study is to quantify postoperative pain after functional endoscopic sinus surgery (FESS) and investigate whether preemptive analgesia may positively impact intraoperative anesthetic management, decrease patient postoperative pain and discomfort, and improve patient functional outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2007

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

August 1, 2007

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

June 23, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 25, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
4.6 years until next milestone

Results Posted

Study results publicly available

March 4, 2015

Completed
Last Updated

May 19, 2016

Status Verified

April 1, 2016

Enrollment Period

2.6 years

First QC Date

June 23, 2009

Results QC Date

December 18, 2012

Last Update Submit

April 19, 2016

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

  • Postoperative Pain Assessed on Standard VAS Scale

    Post-operative quality of recovery and pain followed up to 1 month. Visual Analog Pain (VAS) was recorded by the patient on a 10-centimeter line to mark an estimated pain score that could be from zero (0) to ten (10). Zero would indicate no pain while a score of 10 would be the worse pain possible.

    VAS Pain Score at 7 days

Secondary Outcomes (1)

  • SNOT-20 Surgical Outcome Score

    1-day

Study Arms (2)

1 - Bupivacaine Block

ACTIVE COMPARATOR

3 ml of 0.25% Bupivacaine with Epi 1:100,000 (A block)

Drug: Bupivacaine Block

2 - Placebo

PLACEBO COMPARATOR

Normal saline with Epi 1:100,000 (B block)

Drug: Placebo

Interventions

Bupivacaine BlockDRUG

Bupivacaine local anesthesia block prior to start of FESS procedure.

Also known as: Local Block
1 - Bupivacaine Block
PlaceboDRUG

placebo is identical in appearance in comparison to active drug.

Also known as: Placebo saline injection
2 - Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The study subjects will be 18-70 year old.
  • The subjects will be American Society of Anesthesiology physical status I and II patients.
  • Patients with chronic rhinosinusitis, presenting for bilateral functional endoscopic sinus surgery.
  • The subjects should understand informed consent and study instructions, AND 5. The subjects should not participate in any other research protocols.

You may not qualify if:

  • Patients with pre-existing chronic facial pain not related to chronic rhinosinusitis.
  • Patients with pre-existing chronic pain of different etiology.
  • Patients taking prescription pain medications.
  • Patients taking antidepressant medications.
  • Patients taking over-the-counter pain medications within 48 hours of scheduled surgery.
  • Patients in whom oral opioid-containing analgesics would be contraindicated postoperatively.
  • Patients with a known or suspected genetic susceptibility to malignant hyperthermia, or known sensitivity to Desflurane or other halogenated agents.
  • Patients with the history of arrhythmias or significant coronary artery disease.
  • Patients with psychological disorders.
  • Patients who are unable to understand the questionnaires or the visual analogue scale (VAS) pain scores.
  • Patients with the history of substance or alcohol abuse.
  • Patients with compromised renal and liver function.
  • Patients with abnormal coagulation status or platelet count less than 100,000.
  • Pregnant patients.
  • Patients with an allergy to Bupivacaine, Lidocaine or Epinephrine.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (1)

  • Cho DY, Drover DR, Nekhendzy V, Butwick AJ, Collins J, Hwang PH. The effectiveness of preemptive sphenopalatine ganglion block on postoperative pain and functional outcomes after functional endoscopic sinus surgery. Int Forum Allergy Rhinol. 2011 May-Jun;1(3):212-8. doi: 10.1002/alr.20040. Epub 2011 Apr 13.

    PMID: 22287376RESULT

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Results Point of Contact

Title
David Drover, MD
Organization
Stanford University
ddrover@stanford.edu
6507250364

Study Officials

  • David R. Drover

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 23, 2009

First Posted

June 25, 2009

Study Start

August 1, 2007

Primary Completion

March 1, 2010

Study Completion

August 1, 2010

Last Updated

May 19, 2016

Results First Posted

March 4, 2015

Record last verified: 2016-04

Locations

US(1)