A Comparison Between Conventional and Waveform-Confirmed Loss-of-Resistance for Thoracic Epidural Blocks

• Sponsor: Montreal General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02479763
• Collaborator: (none)
• Enrollment: 106
• Locations: 2
• Arms: 2
• Duration (Months): 6
• Patients Per Site: 53
• Patients Per Site Per Month: 8.8

Study Details

Study Description

Brief Summary

In the investigators' institution, the failure rate for thoracic epidural blocks is 23.1%. This stems from the prevalence of trainee operators coupled with the non-specific nature of loss-of-resistance. In the current randomized trial, we will set out to compare conventional and epidural waveform analysis-confirmed loss-of-resistance. The investigators' research hypothesis is that loss-of-resistance combined with epidural waveform analysis will decrease the failure rate of thoracic epidural blocks.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia	Procedure: Waveform-confirmed loss-of-resistance	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 106 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized Comparison Between Conventional and Waveform-Confirmed Loss-of-Resistance for Thoracic Epidural Blocks
• Study Start Date: Jun 1, 2015
• Actual Primary Completion Date: Dec 1, 2015
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Conventional loss-of-resistance
Experimental: Waveform-confirmed loss-of-resistance	Procedure: Waveform-confirmed loss-of-resistance; Using waveform analysis to confirm thoracic epidural space

Outcome Measures

Primary Outcome Measures

1. Percentage of Patients With Successful Epidural Blocks [up to 15 minutes after the procedure]

   Fifteen minutes after the LA injection, a blinded observer will apply ice to the T1-L4 dermatomes and assess the epidural block. The criterion standard for success will be the presence of an epidural block (defined as a block to ice in at least 2 dermatomes bilaterally). If the operators cannot thread the catheter after 2 attempts, epidural blocks will considered failures.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• the patients undergoing thoracic epidural catheter insertion for thoracic and abdominal surgery or rib fractures with American Society of Anesthesiologists (ASA) classification 1-3 and body mass index between 18 and 35

Exclusion Criteria:

• adults who are unable to give their own consent

• coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up ie platelets ≤ 100, or International Normalized Ratio ≥ 1.4)

• renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up ie creatinine ≥ 100)

• hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up ie transaminases ≥ 100)

• allergy to local anesthetic (LA)

• pregnancy

• prior surgery in the thoracic spine

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Montreal General Hospital, McGill University	Montreal	Quebec	Canada	H3G 1A4
2	Ramathibodi Hospital, Mahidol University	Ratchathewi	Bangkok	Thailand	10400

Sponsors and Collaborators

• Montreal General Hospital

Investigators

• Principal Investigator: De QH Tran, McGill University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: De QH Tran, Associate professor, Montreal General Hospital
• ClinicalTrials.gov Identifier: NCT02479763
• Other Study ID Numbers: 15-077 MUHC
• First Posted: Jun 24, 2015
• Last Update Posted: Feb 22, 2016
• Last Verified: Jan 1, 2016

• Keywords provided by De QH Tran, Associate professor, Montreal General Hospital: Epidural waveform analysis; Loss of resistance

Study Results

Participant Flow

Arm/Group Title	Conventional Loss-of-resistance	Waveform-confirmed Loss-of-resistance
Arm/Group Description	Conventional loss-of-resistance: Using tactile feeling to identify thoracic epidural space	Waveform-confirmed loss-of-resistance: Using waveform analysis to confirm thoracic epidural space
Period Title: Overall Study
STARTED	53	53
COMPLETED	50	50
NOT COMPLETED	3	3

Baseline Characteristics

Arm/Group Title	Conventional Loss-of-resistance	Waveform-confirmed Loss-of-resistance	Total
Arm/Group Description	Conventional loss-of-resistance: Using tactile feeling to identify thoracic epidural space	Waveform-confirmed loss-of-resistance: Using waveform analysis to confirm thoracic epidural space	Total of all reporting groups
Overall Participants	50	50	100
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.4 (11.0)	61.1 (11.8)	61.3 (11.4)
Sex: Female, Male (Count of Participants)
Female	16 32%	20 40%	36 36%
Male	34 68%	30 60%	64 64%
BMI (kg/m^2), Continuous (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	25.5 (4.4)	24.6 (3.7)	25.1 (4.1)
American Society of Anesthesiologists (ASA) physical status, Categorical (participants) [Number]
Class I; A normal healthy patient	3 6%	9 18%	12 12%
Class II; A patient with mild systemic disease	21 42%	23 46%	44 44%
Class III; A patient with severe systemic disease	26 52%	18 36%	44 44%

Outcome Measures

1. Primary Outcome

Title	Percentage of Patients With Successful Epidural Blocks
Description	Fifteen minutes after the LA injection, a blinded observer will apply ice to the T1-L4 dermatomes and assess the epidural block. The criterion standard for success will be the presence of an epidural block (defined as a block to ice in at least 2 dermatomes bilaterally). If the operators cannot thread the catheter after 2 attempts, epidural blocks will considered failures.
Time Frame	up to 15 minutes after the procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Conventional Loss-of-resistance	Waveform-confirmed Loss-of-resistance
Arm/Group Description	Waveform-confirmed loss-of-resistance: Using waveform analysis to confirm thoracic epidural space
Measure Participants	50	50
Number [percentage of patients]	76	98

Adverse Events

Arm/Group Title	Conventional Loss-of-resistance		Waveform-confirmed Loss-of-resistance
Arm/Group Description	Waveform-confirmed loss-of-resistance: Using waveform analysis to confirm thoracic epidural space
All Cause Mortality
	Conventional Loss-of-resistance		Waveform-confirmed Loss-of-resistance
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Conventional Loss-of-resistance		Waveform-confirmed Loss-of-resistance
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/50 (0%)		0/50 (0%)
Other (Not Including Serious) Adverse Events
	Conventional Loss-of-resistance		Waveform-confirmed Loss-of-resistance
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/50 (4%)		2/50 (4%)
Nervous system disorders
Transient self-resolving paresthesia	0/50 (0%)	0	2/50 (4%)	2
Vascular disorders
Vascular breach	2/50 (4%)	2	0/50 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.