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Postoperative Pain and Functional Patient Outcomes After Functional Endoscopic Sinus Surgery

Primary Purpose

Pain, Postoperative

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Bupivacaine Block

Placebo

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

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

Inclusion Criteria:

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.

Exclusion Criteria:

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.
Other patients that may be excluded by the investigator, based on medical history and physical examination

Sites / Locations

Stanford University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1 - Bupivacaine Block

2 - Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

SNOT-20 Surgical Outcome Score

This measures uses a 20 item surgical assessment tool to assess surgical field. This assessment score is the Sino-Nasal Outcome Test, SNOT-20. Patients were completed this validated sinus symptom questionnaire. The average magnitude score for the 20 items is calculated. Each item of the 20-question assessment is scored from 1 to 5 where 1 is less severe and 5 is a maximum as described by that particular symptom score. The final score is reported as a mean with a range of 0 (zero) to 5 (no units). ref. Otolaryngol Head Neck Surg, 126 (2002), pp. 41-47

Full Information

NCT ID

NCT00927888

First Posted

June 23, 2009

Last Updated

April 19, 2016

Sponsor

Stanford University

Collaborators

Hospira, now a wholly owned subsidiary of Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00927888

Brief Title

Postoperative Pain and Functional Patient Outcomes After Functional Endoscopic Sinus Surgery

Official Title

The Effect of Preemptive Sphenopalatine Ganglion Block on Anesthetic Requirements, Postoperative Pain and Functional Patient Outcomes After Functional Endoscopic Sinus Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Completed

Study Start Date

August 2007 (undefined)

Primary Completion Date

March 2010 (Actual)

Study Completion Date

August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

Collaborators

Hospira, now a wholly owned subsidiary of Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

The sphenopalatine ganglion block (SPGB) with local anesthetic is used to treat facial pain and headache of various etiologies and has been widely used during functional endoscopic sinus surgery (FESS). The purpose of this study was to investigate whether preemptive SPGB may positively impact postoperative pain and functional outcomes after FESS. A prospective, double-blind randomized placebo-controlled study was performed. 60 patients (18 to 70 yrs), undergoing general anesthesia for bilateral FESS, were randomly assigned to receive SPGB with either 2 ml 0.25% bupivacaine with epinephrine 1:100,000 (BP, treatment group) or normal saline (NS, control group). SPGB was performed preemptively 10 min before the start of surgery. Pre- and post operative (day#0, day#7, day#30) visual analogue pain scale, SNOT-20, CT & Endoscopic scores were compared between the two groups.

6. Conditions and Keywords

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

Pain, Postoperative

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

56 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1 - Bupivacaine Block

Arm Type

Active Comparator

Arm Description

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

Arm Title

2 - Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Bupivacaine Block

Other Intervention Name(s)

Local Block

Intervention Description

Bupivacaine local anesthesia block prior to start of FESS procedure.

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Placebo saline injection

Intervention Description

placebo is identical in appearance in comparison to active drug.

Primary Outcome Measure Information:

Title

Postoperative Pain Assessed on Standard VAS Scale

Description

Time Frame

VAS Pain Score at 7 days

Secondary Outcome Measure Information:

Title

SNOT-20 Surgical Outcome Score

Description

Time Frame

1-day

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: 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. Exclusion Criteria: 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. Other patients that may be excluded by the investigator, based on medical history and physical examination

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David R. Drover

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford University School of Medicine

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

22287376

Citation

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.

Results Reference

result

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Postoperative Pain and Functional Patient Outcomes After Functional Endoscopic Sinus Surgery

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