Trial Outcomes & Findings for Analgesic Benefits of Perineural Versus Intravenous Dexamethasone in Patients Receiving Sciatic Nerve Block (NCT NCT01616173)

Results Overview

QoR-40 questionnaire instrument consists of 40 questions that examine 5 domains of patient recovery using a 5 point Likert scale: none of the time, some of the time, usually, most of the time and all of the time. The five domains include physical comfort, pain, physical independence, psychological support and emotional state. Global QoR-40 scores range from minimum of 40 to a maximum of 200. The scores are added together to compute a total score. A low score of 40 represents very poor quality of recovery while a high score, i.e. 200 represents outstanding quality of recovery.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

80 participants

Primary outcome timeframe

2 weeks

Results posted on

2014-11-20

Participant Flow

Participant milestones

Participant milestones
Measure	Perineural Dexamethasone Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine and perineural dexamethasone 8mg/2mL ,and 50mL IV normal saline infusion	Intravenous Dexamethasone Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and IV dexamethsone 8mg in 50mL infusion	No Perioperative Steroids Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and 50mL saline infusion
Overall Study STARTED	27	26	27
Overall Study COMPLETED	27	24	27
Overall Study NOT COMPLETED	0	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Perineural Dexamethasone Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine and perineural dexamethasone 8mg/2mL ,and 50mL IV normal saline infusion	Intravenous Dexamethasone Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and IV dexamethsone 8mg in 50mL infusion	No Perioperative Steroids Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and 50mL saline infusion
Overall Study Lost to Follow-up	0	2	0

Baseline Characteristics

Analgesic Benefits of Perineural Versus Intravenous Dexamethasone in Patients Receiving Sciatic Nerve Block

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intravenous Dexamethasone n=26 Participants Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and IV dexamethsone 8mg in 50mL infusion	No Perioperative Steroids n=27 Participants Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and 50mL saline infusion	Total n=80 Participants Total of all reporting groups	Perineural Dexamethasone n=27 Participants Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine and perineural dexamethasone 8mg/2mL ,and 50mL IV normal saline infusion
Age, Continuous	47 years n=7 Participants	39 years n=5 Participants	43 years n=4 Participants	42 years n=5 Participants
Sex: Female, Male Female	13 Participants n=7 Participants	11 Participants n=5 Participants	37 Participants n=4 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=7 Participants	16 Participants n=5 Participants	43 Participants n=4 Participants	14 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks

QoR-40 questionnaire instrument consists of 40 questions that examine 5 domains of patient recovery using a 5 point Likert scale: none of the time, some of the time, usually, most of the time and all of the time. The five domains include physical comfort, pain, physical independence, psychological support and emotional state. Global QoR-40 scores range from minimum of 40 to a maximum of 200. The scores are added together to compute a total score. A low score of 40 represents very poor quality of recovery while a high score, i.e. 200 represents outstanding quality of recovery.

Outcome measures

Outcome measures
Measure	Perineural Dexamethasone n=27 Participants Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine and perineural dexamethasone 8mg/2mL ,and 50mL IV normal saline infusion	Intravenous Dexamethasone n=24 Participants Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and IV dexamethsone 8mg in 50mL infusion	No Perioperative Steroids n=27 Participants Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and 50mL saline infusion
Quality of Recovery	181 units on a scale Interval 178.0 to 187.0	184 units on a scale Interval 181.0 to 188.0	181 units on a scale Interval 176.0 to 187.0

SECONDARY outcome

Timeframe: 2 weeks

Postoperative opioid consumption was converted to equivalent dose of oral morphine at two weeks following surgery.

Outcome measures

Outcome measures
Measure	Perineural Dexamethasone n=27 Participants Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine and perineural dexamethasone 8mg/2mL ,and 50mL IV normal saline infusion	Intravenous Dexamethasone n=24 Participants Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and IV dexamethsone 8mg in 50mL infusion	No Perioperative Steroids n=27 Participants Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and 50mL saline infusion
Opioid Consumption	0 mg/day Interval 0.0 to 7.5	0 mg/day Interval 0.0 to 7.0	0 mg/day Interval 0.0 to 7.5

SECONDARY outcome

Timeframe: 2 weeks

Patients were asked to rate their pain score during activity on a 11-point scale (0 = no pain to 10 = excruciating pain).

Outcome measures

Outcome measures
Measure	Perineural Dexamethasone n=27 Participants Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine and perineural dexamethasone 8mg/2mL ,and 50mL IV normal saline infusion	Intravenous Dexamethasone n=24 Participants Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and IV dexamethsone 8mg in 50mL infusion	No Perioperative Steroids n=27 Participants Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and 50mL saline infusion
Pain Scores	2 units on a scale Interval 0.0 to 4.0	2.5 units on a scale Interval 1.0 to 4.0	2 units on a scale Interval 0.0 to 5.0

Adverse Events

Perineural Dexamethasone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intravenous Dexamethasone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Perioperative Steroids

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

Rohit Rahangdale MD

Northwestern University, Feinberg School of Medicine

Phone: 312-695-3045

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place