Trial Outcomes & Findings for Adductor Canal Mid-thigh and Adductor Canal Distal Thigh: Is Cutaneous Sensory Blockade Similar Among Block Techniques? (NCT NCT02788019)

Last Updated: 2021-04-21

Results Overview

The distribution of cutaneous sensation affected by the different techniques of adductor canal blockade is assessed using a monofilament Neuropen to prick points on a 20 point grid applied to the skin in a standard fashion according to this method: A grid will be marked starting with anatomical landmarks at the knee joint: the medial inter-knee-joint point where the tibia meets the femur, the mid medial patella, the mid lateral patella, and along the same line at the semitendinosus tendon and 5cm posterior from that point. Then 5cm intervals will be plotted progressing cephalad to a total of 15 centimeters. This will yield 20 grid points (5x4 points). Once the grid is made, testing proceeds with a Neuropen on a scale of 0-1, with 1 = normal sharp sensation, 0 = change of sensation. The Neuropen is used for the standardization of force.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

52 participants

Primary outcome timeframe

20 minutes

Results posted on

2021-04-21

Participant Flow

Study patients were followed after block procedure for 24 hrs. Adverse events were also monitored within this period.

Participant milestones

Participant milestones
Measure	Mid-Thigh Adductor Block Subject will receive a mid-thigh adductor block method using ropivacaine (0.5%, 15 mL). Ropivacaine: Ropivacaine is routinely used to perform localized blockade prior to surgery to improve management of postoperative pain.	Distal-Thigh Adductor Block Subject will receive a distal-thigh adductor block method using ropivacaine (0.5%, 15 mL). Ropivacaine: Ropivacaine is routinely used to perform localized blockade prior to surgery to improve management of postoperative pain.
Overall Study STARTED	27	25
Overall Study COMPLETED	23	20
Overall Study NOT COMPLETED	4	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Distal-Thigh Adductor Block n=25 Participants Subject will receive a distal-thigh adductor block method using ropivacaine (0.5%, 15 mL). Ropivacaine: Ropivacaine is routinely used to perform localized blockade prior to surgery to improve management of postoperative pain.	Total n=52 Participants Total of all reporting groups	Mid-Thigh Adductor Block n=27 Participants Subject will receive a mid-thigh adductor block method using ropivacaine (0.5%, 15 mL). Ropivacaine: Ropivacaine is routinely used to perform localized blockade prior to surgery to improve management of postoperative pain.
Age, Categorical <=18 years	0 Participants n=25 Participants	0 Participants n=52 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=25 Participants	33 Participants n=52 Participants	17 Participants n=27 Participants
Age, Categorical >=65 years	9 Participants n=25 Participants	19 Participants n=52 Participants	10 Participants n=27 Participants
Age, Continuous	57.84 years STANDARD_DEVIATION 12.37 • n=25 Participants	57.21 years STANDARD_DEVIATION 13.69 • n=52 Participants	56.62 years STANDARD_DEVIATION 15.02 • n=27 Participants
Sex: Female, Male Female	15 Participants n=25 Participants	32 Participants n=52 Participants	17 Participants n=27 Participants
Sex: Female, Male Male	10 Participants n=25 Participants	20 Participants n=52 Participants	10 Participants n=27 Participants
Race and Ethnicity Not Collected	—	0 Participants Race and Ethnicity were not collected from any participant.	—
Region of Enrollment United States	25 Participants n=25 Participants	52 Participants n=52 Participants	27 Participants n=27 Participants
BMI	30.9 kg/m^2 n=25 Participants	29.8 kg/m^2 n=52 Participants	28.5 kg/m^2 n=27 Participants

PRIMARY outcome

Timeframe: 20 minutes

Population: Only patients who were enrolled and had data for both pre and post blockade were considered for this analysis.

Outcome measures

Outcome measures
Measure	Mid-Thigh Adductor Block n=27 Participants Subject will receive a mid-thigh adductor block method using ropivacaine (0.5%, 15 mL). Ropivacaine: Ropivacaine is routinely used to perform localized blockade prior to surgery to improve management of postoperative pain.	Distal-Thigh Adductor Block n=25 Participants Subject will receive a distal-thigh adductor block method using ropivacaine (0.5%, 15 mL). Ropivacaine: Ropivacaine is routinely used to perform localized blockade prior to surgery to improve management of postoperative pain.
Number of Grid Points With Change of Sensation to Pinprick After Blockade	19.81 points of cutaneous sensation Standard Deviation 0.55	20 points of cutaneous sensation Standard Deviation 0

Adverse Events

Mid-Thigh Adductor Block

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Distal-Thigh Adductor 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

Other adverse events
Measure	Mid-Thigh Adductor Block n=27 participants at risk Subject will receive a mid-thigh adductor block method using ropivacaine (0.5%, 15 mL). Ropivacaine: Ropivacaine is routinely used to perform localized blockade prior to surgery to improve management of postoperative pain.	Distal-Thigh Adductor Block n=25 participants at risk Subject will receive a distal-thigh adductor block method using ropivacaine (0.5%, 15 mL). Ropivacaine: Ropivacaine is routinely used to perform localized blockade prior to surgery to improve management of postoperative pain.
Skin and subcutaneous tissue disorders Skin lesion	3.7% 1/27 • Number of events 1 • Adverse Event data was collected from the time point of receiving an adductor block up to 24 hrs post block. We used an electronic version of the National Center for Complementary and Integrative Health (United States National Institutes of Health) adverse collection form.	0.00% 0/25 • Adverse Event data was collected from the time point of receiving an adductor block up to 24 hrs post block. We used an electronic version of the National Center for Complementary and Integrative Health (United States National Institutes of Health) adverse collection form.

Additional Information

Anthony Machi, MD, Assistant Professor

UT Southwestern Medical Center

Phone: 214-648-6400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place