Trial Outcomes & Findings for Postoperative Pain and Functional Patient Outcomes After Functional Endoscopic Sinus Surgery (NCT NCT00927888)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

56 participants

Primary outcome timeframe

VAS Pain Score at 7 days

Results posted on

2016-05-19

Participant Flow

Stanford medical center

Having unilateral FESS

Participant milestones

Participant milestones
Measure	Group 1 - Bupivacaine Block Active treatment group with application of bupivacaine block before FESS.	Group 2 - Placebo Saline Block This group proceeded as per teh active treatment group but with blinded use of saline in the block syringe before start of FESS.
Overall Study STARTED	29	27
Overall Study COMPLETED	29	27
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Postoperative Pain and Functional Patient Outcomes After Functional Endoscopic Sinus Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 Bupivacaine n=29 Participants Active treatment group with application of bupivacaine block before FESS.	Group 2 - Saline Placebo Group n=27 Participants Saline substituted in block, placebo treatment group with application of saline block before FESS.	Total n=56 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=5 Participants	21 Participants n=7 Participants	47 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Age, Continuous	49 years n=5 Participants	42 years n=7 Participants	45 years n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	20 Participants n=7 Participants	41 Participants n=5 Participants
Region of Enrollment United States	29 participants n=5 Participants	27 participants n=7 Participants	56 participants n=5 Participants

PRIMARY outcome

Timeframe: VAS Pain Score at 7 days

Population: Entire population of both groups.

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.

Outcome measures

Outcome measures
Measure	1 - Bupivacaine Block n=29 VAS 3 ml of 0.25% Bupivacaine with Epi 1:100,000 (A block) Bupivacaine Block: Bupivacaine local anesthesia block prior to start of FESS procedure.	2 - Placebo n=27 VAS Normal saline with Epi 1:100,000 (B block)
Postoperative Pain Assessed on Standard VAS Scale	0.48 units on a scale Standard Deviation 0.23	1.12 units on a scale Standard Deviation 0.3

SECONDARY outcome

Timeframe: 1-day

Population: Entire study population included.

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

Outcome measures

Outcome measures
Measure	1 - Bupivacaine Block n=29 Score 3 ml of 0.25% Bupivacaine with Epi 1:100,000 (A block) Bupivacaine Block: Bupivacaine local anesthesia block prior to start of FESS procedure.	2 - Placebo n=27 Score Normal saline with Epi 1:100,000 (B block)
SNOT-20 Surgical Outcome Score	1.76 units on a scale Standard Deviation 0.2	1.67 units on a scale Standard Deviation 0.2

Adverse Events

Group 1 - Bupicaine Block

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group 2 - Saline Placebo Block

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

David Drover, MD

Stanford University

Phone: 6507250364

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place