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NCT Number: NCT00927888

Postoperative Pain and Functional Patient Outcomes After Functional Endoscopic Sinus Surgery

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.

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacaine Block

Drug

Bupivacaine local anesthesia block prior to start of FESS procedure.

Other names: Local Block

Placebo

Drug

placebo is identical in appearance in comparison to active drug.

Other names: Placebo saline injection

Primary outcomes

  1. Postoperative Pain Assessed on Standard VAS Scale

    Time frame: VAS Pain Score at 7 days

    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 outcomes

  1. SNOT-20 Surgical Outcome Score

    Time frame: 1-day

    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

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Hospira, now a wholly owned subsidiary of Pfizer

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Jun 25, 2009
Registry last updated
May 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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