Postoperative Pain and Functional Patient Outcomes After Functional Endoscopic Sinus Surgery

This study has been completed.
Sponsor:
Collaborator:
Hospira, Inc.
Information provided by (Responsible Party):
David R. Drover, Stanford University
ClinicalTrials.gov Identifier:
NCT00927888
First received: June 23, 2009
Last updated: March 2, 2015
Last verified: March 2015
  Purpose

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.


Condition Intervention Phase
Pain, Postoperative
Drug: Bupivacaine Block
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Preemptive Sphenopalatine Ganglion Block on Anesthetic Requirements, Postoperative Pain and Functional Patient Outcomes After Functional Endoscopic Sinus Surgery

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Postoperative Pain Assessed on Standard VAS Scale [ Time Frame: VAS Pain Score at 7 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1-day ] [ Designated as safety issue: No ]

    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



Enrollment: 56
Study Start Date: August 2007
Study Completion Date: August 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 - Bupivacaine Block
3 ml of 0.25% Bupivacaine with Epi 1:100,000 (A block)
Drug: Bupivacaine Block
Bupivacaine local anesthesia block prior to start of FESS procedure.
Other Name: Local Block
Placebo Comparator: 2 - Placebo
Normal saline with Epi 1:100,000 (B block)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patients with pre-existing chronic facial pain not related to chronic rhinosinusitis.
  2. Patients with pre-existing chronic pain of different etiology.
  3. Patients taking prescription pain medications.
  4. Patients taking antidepressant medications.
  5. Patients taking over-the-counter pain medications within 48 hours of scheduled surgery.
  6. Patients in whom oral opioid-containing analgesics would be contraindicated postoperatively.
  7. Patients with a known or suspected genetic susceptibility to malignant hyperthermia, or known sensitivity to Desflurane or other halogenated agents.
  8. Patients with the history of arrhythmias or significant coronary artery disease.
  9. Patients with psychological disorders.
  10. Patients who are unable to understand the questionnaires or the visual analogue scale (VAS) pain scores.
  11. Patients with the history of substance or alcohol abuse.
  12. Patients with compromised renal and liver function.
  13. Patients with abnormal coagulation status or platelet count less than 100,000.
  14. Pregnant patients.
  15. Patients with an allergy to Bupivacaine, Lidocaine or Epinephrine.
  16. Other patients that may be excluded by the investigator, based on medical history and physical examination
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00927888

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Hospira, Inc.
Investigators
Principal Investigator: David R. Drover Stanford University
  More Information

Publications:
Responsible Party: David R. Drover, Professor, Stanford University
ClinicalTrials.gov Identifier: NCT00927888     History of Changes
Other Study ID Numbers: SU-05072009-2478
Study First Received: June 23, 2009
Results First Received: December 18, 2012
Last Updated: March 2, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Bupivacaine
Anesthetics
Anesthetics, Local
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 30, 2015