Trial Outcomes & Findings for A Comparison of Ropivacaine Alone Versus Combination of Dexamethasone and Clonidine for Block (NCT NCT02151487)

NCT ID: NCT02151487

Last Updated: 2019-07-05

Results Overview

Duration of sensorial block defined as the time interval between subject admitted to the Post-Anesthesia Care Unit and the time the first pain medication taken at home

• Recruitment status: COMPLETED
• Target enrollment: 97 participants
• Primary outcome timeframe: within 24-hr after surgery
• Results posted on: 2019-07-05

Participant Flow

Study takes place in routine clinical context. Subjects who received supraclavicular nerve block with ropivacaine alone or ropivacaine with adjuvants enrolled to the study.

Participant milestones

Measure	Ropivacaine Ropivacaine 0.5% 25 ml alone for supraclavicular block Ropivacaine: Ropivacaine alone	Ropivacaine and Dexamethasone 25 ml 0.5% ropivacaine + 4 mg dexamethasone Ropivacaine and dexamethasone: Ropivacaine combination with dexamethasone	Ropivacaine and Clonidine 25 ml 0.5% ropivacaine + 100 mcg clonidine Ropivacaine and clonidine: Ropivacaine combination with clonidine	Ropivacaine, Dexamethasone and Clonidine 25 ml 0.5% ropivacaine + 4 mg dexamethasone + 100 mcg clonidine Ropivacaine, dexamethasone and clonidine: Ropivacaine combination with dexamethasone and clonidine
Overall Study STARTED	27	27	20	23
Overall Study COMPLETED	25	22	16	20
Overall Study NOT COMPLETED	2	5	4	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Participants were ambulatory cases and followed with 24 h phone call visit. Due to follow-up lost, analysis population is lower than overall population.

Baseline characteristics by cohort

Measure	Ropivacaine n=27 Participants Ropivacaine 0.5% 25 ml alone for supraclavicular block Ropivacaine: Ropivacaine alone	Ropivacaine and Dexamethasone n=27 Participants 25 ml 0.5% ropivacaine + 4 mg dexamethasone Ropivacaine and dexamethasone: Ropivacaine combination with dexamethasone	Ropivacaine and Clonidine n=20 Participants 25 ml 0.5% ropivacaine + 100 mcg clonidine Ropivacaine and clonidine: Ropivacaine combination with clonidine	Ropivacaine, Dexamethasone and Clonidine n=23 Participants 25 ml 0.5% ropivacaine + 4 mg dexamethasone + 100 mcg clonidine Ropivacaine, dexamethasone and clonidine: Ropivacaine combination with dexamethasone and clonidine	Total n=97 Participants Total of all reporting groups
Age, Continuous	49 years STANDARD_DEVIATION 16 • n=25 Participants • Participants were ambulatory cases and followed with 24 h phone call visit. Due to follow-up lost, analysis population is lower than overall population.	43 years STANDARD_DEVIATION 14 • n=22 Participants • Participants were ambulatory cases and followed with 24 h phone call visit. Due to follow-up lost, analysis population is lower than overall population.	48 years STANDARD_DEVIATION 11 • n=16 Participants • Participants were ambulatory cases and followed with 24 h phone call visit. Due to follow-up lost, analysis population is lower than overall population.	50 years STANDARD_DEVIATION 11 • n=20 Participants • Participants were ambulatory cases and followed with 24 h phone call visit. Due to follow-up lost, analysis population is lower than overall population.	48 years STANDARD_DEVIATION 13 • n=83 Participants • Participants were ambulatory cases and followed with 24 h phone call visit. Due to follow-up lost, analysis population is lower than overall population.
Sex: Female, Male Female	10 Participants n=25 Participants • Subjects were ambulatory surgery cases and followed via phone call visit 24 hours after discharge.	13 Participants n=22 Participants • Subjects were ambulatory surgery cases and followed via phone call visit 24 hours after discharge.	8 Participants n=16 Participants • Subjects were ambulatory surgery cases and followed via phone call visit 24 hours after discharge.	10 Participants n=20 Participants • Subjects were ambulatory surgery cases and followed via phone call visit 24 hours after discharge.	41 Participants n=83 Participants • Subjects were ambulatory surgery cases and followed via phone call visit 24 hours after discharge.
Sex: Female, Male Male	15 Participants n=25 Participants • Subjects were ambulatory surgery cases and followed via phone call visit 24 hours after discharge.	9 Participants n=22 Participants • Subjects were ambulatory surgery cases and followed via phone call visit 24 hours after discharge.	8 Participants n=16 Participants • Subjects were ambulatory surgery cases and followed via phone call visit 24 hours after discharge.	10 Participants n=20 Participants • Subjects were ambulatory surgery cases and followed via phone call visit 24 hours after discharge.	42 Participants n=83 Participants • Subjects were ambulatory surgery cases and followed via phone call visit 24 hours after discharge.

PRIMARY outcome

Timeframe: within 24-hr after surgery

Population: Participants received supraclavicular nerve block with ropivacaine alone and ropivacaine with adjuvants.

Duration of sensorial block defined as the time interval between subject admitted to the Post-Anesthesia Care Unit and the time the first pain medication taken at home

Outcome measures

Measure	Ropivacaine n=25 Participants Ropivacaine 0.5% 25 ml alone for supraclavicular block Ropivacaine: Ropivacaine alone	Ropivacaine and Dexamethasone n=22 Participants 25 ml 0.5% ropivacaine + 4 mg dexamethasone Ropivacaine and dexamethasone: Ropivacaine combination with dexamethasone	Ropivacaine and Clonidine n=16 Participants 25 ml 0.5% ropivacaine + 100 mcg clonidine Ropivacaine and clonidine: Ropivacaine combination with clonidine	Ropivacaine, Dexamethasone and Clonidine n=20 Participants 25 ml 0.5% ropivacaine + 4 mg dexamethasone + 100 mcg clonidine Ropivacaine, dexamethasone and clonidine: Ropivacaine combination with dexamethasone and clonidine
Duration of the Sensorial Supraclavicular Block	13.4 hour Standard Deviation 6	14 hour Standard Deviation 6.6	17.4 hour Standard Deviation 6	18.8 hour Standard Deviation 6.2

SECONDARY outcome

Timeframe: within 15 minutes at postanesthesia care unit (PACU) arrival

Population: Patients received supraclavicular nerve block with ropivacaine alone or ropivacaine with adjuvants. Postoperative pain was evaluated by using Visual Analog Pain Scores on the scale of 10 (0=no pain and 10-worse pain).

Post-operative Visual Analog Pain (VAS) scores on the scale of 10 (0=no pain and 10=worse imaginary pain).

Outcome measures

Measure	Ropivacaine n=25 Participants Ropivacaine 0.5% 25 ml alone for supraclavicular block Ropivacaine: Ropivacaine alone	Ropivacaine and Dexamethasone n=22 Participants 25 ml 0.5% ropivacaine + 4 mg dexamethasone Ropivacaine and dexamethasone: Ropivacaine combination with dexamethasone	Ropivacaine and Clonidine n=16 Participants 25 ml 0.5% ropivacaine + 100 mcg clonidine Ropivacaine and clonidine: Ropivacaine combination with clonidine	Ropivacaine, Dexamethasone and Clonidine n=20 Participants 25 ml 0.5% ropivacaine + 4 mg dexamethasone + 100 mcg clonidine Ropivacaine, dexamethasone and clonidine: Ropivacaine combination with dexamethasone and clonidine
Postoperative Analgesia	0 score on a scale of 10 Interval 0.0 to 0.0	0 score on a scale of 10 Interval 0.0 to 0.0	0 score on a scale of 10 Interval 0.0 to 0.0	0 score on a scale of 10 Interval 0.0 to 0.0

Adverse Events

Ropivacaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ropivacaine and Dexamethasone

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Ropivacaine and Clonidine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ropivacaine, Dexamethasone and Clonidine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Ropivacaine n=27 participants at risk Ropivacaine 0.5% 25 ml alone for supraclavicular block Ropivacaine: Ropivacaine alone	Ropivacaine and Dexamethasone n=27 participants at risk 25 ml 0.5% ropivacaine + 4 mg dexamethasone Ropivacaine and dexamethasone: Ropivacaine combination with dexamethasone	Ropivacaine and Clonidine n=20 participants at risk 25 ml 0.5% ropivacaine + 100 mcg clonidine Ropivacaine and clonidine: Ropivacaine combination with clonidine	Ropivacaine, Dexamethasone and Clonidine n=23 participants at risk 25 ml 0.5% ropivacaine + 4 mg dexamethasone + 100 mcg clonidine Ropivacaine, dexamethasone and clonidine: Ropivacaine combination with dexamethasone and clonidine
Respiratory, thoracic and mediastinal disorders Shortness of breath (SOB)	0.00% 0/27 • Following nerve block to postoperative 24 hour period.	3.7% 1/27 • Number of events 1 • Following nerve block to postoperative 24 hour period.	0.00% 0/20 • Following nerve block to postoperative 24 hour period.	0.00% 0/23 • Following nerve block to postoperative 24 hour period.

Additional Information

Dawood Nasir

UT Southwestern Medical Center

Phone: 214-590-5352

Email: Dawood.Nasir@UTSouthwestern.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place