Trial Outcomes & Findings for Comparison of Obturator Nerve Blockade and Neuromuscular Blockade (NCT NCT03063255)

Results Overview

Nerve Integrity Monitor will be used to detect adductor spasm and below are listed the numbers or patients with increased incidence of adductor spasm.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

60 participants

Primary outcome timeframe

intraoperative

Results posted on

2021-03-24

Participant Flow

The first subject enrolled was on 04/25/2017 and the last subject enrolled was on 6/11/2019. All subjects were enrolled at the Malcom Randall VAMC.

Participant milestones

Participant milestones
Measure	Obturator Block Comparing the incidence of adductor spasm in patients undergoing general anesthesia with obturator block. Obturator block: Subjects allocated to the obturator block group will be monitored for the incidence of block and procedure-related adverse events. In addition to clinical observation, a Nerve Integrity Monitor (Medtronic) will be used to detect adductor spasm using continuous electromyography. Electrodes will be placed on the thigh to objectively detect and record instances of adductor spasm. One hour after arrival to post-anaesthesia care unit (PACU) or when discharge criteria are met (whichever comes first), repeat dynamometer measurements and TUG tests will be performed. Patients will be called 24-48 hours post procedure to inquire about falls or evidence of nerve injury, as well as patient satisfaction.	Neuromuscular Block Comparing the incidence of adductor spasm in patients undergoing general anesthesia with neuromuscular blocking agents. Neuromuscular block: Subjects allocated to the neuromuscular block group will be monitored for the incidence of block and procedure-related adverse events. In addition to clinical observation, a Nerve Integrity Monitor (Medtronic) will be used to detect adductor spasm using continuous electromyography. Electrodes will be placed on the thigh to objectively detect and record instances of adductor spasm. One hour after arrival to PACU or when discharge criteria are met (whichever comes first), repeat dynamometer measurements and TUG tests will be performed. Patients will be called 24-48 hours post procedure to inquire about falls or evidence of nerve injury, as well as patient satisfaction.
Overall Study STARTED	30	30
Overall Study COMPLETED	29	30
Overall Study NOT COMPLETED	1	0

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	Obturator Block n=30 Participants Comparing the incidence of adductor spasm in patients undergoing general anesthesia with obturator block. Obturator block: Subjects allocated to the obturator block group will be monitored for the incidence of block and procedure-related adverse events. In addition to clinical observation, a Nerve Integrity Monitor (Medtronic) will be used to detect adductor spasm using continuous electromyography. Electrodes will be placed on the thigh to objectively detect and record instances of adductor spasm. One hour after arrival to post-anaesthesia care unit (PACU) or when discharge criteria are met (whichever comes first), repeat dynamometer measurements and TUG tests will be performed. Patients will be called 24-48 hours post procedure to inquire about falls or evidence of nerve injury, as well as patient satisfaction.	Neuromuscular Block n=30 Participants Comparing the incidence of adductor spasm in patients undergoing general anesthesia with neuromuscular blocking agents. Neuromuscular block: Subjects allocated to the neuromuscular block group will be monitored for the incidence of block and procedure-related adverse events. In addition to clinical observation, a Nerve Integrity Monitor (Medtronic) will be used to detect adductor spasm using continuous electromyography. Electrodes will be placed on the thigh to objectively detect and record instances of adductor spasm. One hour after arrival to PACU or when discharge criteria are met (whichever comes first), repeat dynamometer measurements and TUG tests will be performed. Patients will be called 24-48 hours post procedure to inquire about falls or evidence of nerve injury, as well as patient satisfaction.	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=30 Participants	2 Participants n=30 Participants	8 Participants n=60 Participants
Age, Categorical >=65 years	24 Participants n=30 Participants	28 Participants n=30 Participants	52 Participants n=60 Participants
Age, Continuous	70.2 years STANDARD_DEVIATION 7.3 • n=30 Participants	72.2 years STANDARD_DEVIATION 6.3 • n=30 Participants	71.3 years STANDARD_DEVIATION 6.8 • n=60 Participants
Sex: Female, Male Female	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Sex: Female, Male Male	30 Participants n=30 Participants	30 Participants n=30 Participants	60 Participants n=60 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	30 participants n=30 Participants	30 participants n=30 Participants	60 participants n=60 Participants

PRIMARY outcome

Timeframe: intraoperative

Population: Data entry error correction, one patient withdrawn and only demographic information collected

Nerve Integrity Monitor will be used to detect adductor spasm and below are listed the numbers or patients with increased incidence of adductor spasm.

Outcome measures

Outcome measures
Measure	Obturator Block n=29 Participants Comparing the incidence of adductor spasm in patients undergoing general anesthesia with obturator block. Obturator block: Subjects allocated to the obturator block group will be monitored for the incidence of block and procedure-related adverse events. In addition to clinical observation, a Nerve Integrity Monitor (Medtronic) will be used to detect adductor spasm using continuous electromyography. Electrodes will be placed on the thigh to objectively detect and record instances of adductor spasm. One hour after arrival to post-anaesthesia care unit (PACU) or when discharge criteria are met (whichever comes first), repeat dynamometer measurements and TUG tests will be performed. Patients will be called 24-48 hours post procedure to inquire about falls or evidence of nerve injury, as well as patient satisfaction.	Neuromuscular Block n=30 Participants Comparing the incidence of adductor spasm in patients undergoing general anesthesia with neuromuscular blocking agents. Neuromuscular block: Subjects allocated to the neuromuscular block group will be monitored for the incidence of block and procedure-related adverse events. In addition to clinical observation, a Nerve Integrity Monitor (Medtronic) will be used to detect adductor spasm using continuous electromyography. Electrodes will be placed on the thigh to objectively detect and record instances of adductor spasm. One hour after arrival to PACU or when discharge criteria are met (whichever comes first), repeat dynamometer measurements and TUG tests will be performed. Patients will be called 24-48 hours post procedure to inquire about falls or evidence of nerve injury, as well as patient satisfaction.
Number of Patients With Incidence of Intraoperative Adductor Spasm	1 Participants	5 Participants

SECONDARY outcome

Timeframe: Changes from baseline (pre-op) to 72 hours post-operative

Population: Data entry error correction, one patient withdrawn and only demographic information collected

Based on TUG time measurements of patients below are the numbers of patients with an increased risk of falling.

Outcome measures

Outcome measures
Measure	Obturator Block n=29 Participants Comparing the incidence of adductor spasm in patients undergoing general anesthesia with obturator block. Obturator block: Subjects allocated to the obturator block group will be monitored for the incidence of block and procedure-related adverse events. In addition to clinical observation, a Nerve Integrity Monitor (Medtronic) will be used to detect adductor spasm using continuous electromyography. Electrodes will be placed on the thigh to objectively detect and record instances of adductor spasm. One hour after arrival to post-anaesthesia care unit (PACU) or when discharge criteria are met (whichever comes first), repeat dynamometer measurements and TUG tests will be performed. Patients will be called 24-48 hours post procedure to inquire about falls or evidence of nerve injury, as well as patient satisfaction.	Neuromuscular Block n=30 Participants Comparing the incidence of adductor spasm in patients undergoing general anesthesia with neuromuscular blocking agents. Neuromuscular block: Subjects allocated to the neuromuscular block group will be monitored for the incidence of block and procedure-related adverse events. In addition to clinical observation, a Nerve Integrity Monitor (Medtronic) will be used to detect adductor spasm using continuous electromyography. Electrodes will be placed on the thigh to objectively detect and record instances of adductor spasm. One hour after arrival to PACU or when discharge criteria are met (whichever comes first), repeat dynamometer measurements and TUG tests will be performed. Patients will be called 24-48 hours post procedure to inquire about falls or evidence of nerve injury, as well as patient satisfaction.
Number Patients With Increased Risk of Falling	28 participants	29 participants

SECONDARY outcome

Timeframe: Changes from baseline (pre-op) to 72 hours post-operative

Population: Data entry error correction, one patient withdrawn and only demographic information collected

Test the strength of subject's lower extremity muscles on the timed up and go (TUG) test and determine how many patients had increased leg weakness.

Outcome measures

Outcome measures
Measure	Obturator Block n=29 Participants Comparing the incidence of adductor spasm in patients undergoing general anesthesia with obturator block. Obturator block: Subjects allocated to the obturator block group will be monitored for the incidence of block and procedure-related adverse events. In addition to clinical observation, a Nerve Integrity Monitor (Medtronic) will be used to detect adductor spasm using continuous electromyography. Electrodes will be placed on the thigh to objectively detect and record instances of adductor spasm. One hour after arrival to post-anaesthesia care unit (PACU) or when discharge criteria are met (whichever comes first), repeat dynamometer measurements and TUG tests will be performed. Patients will be called 24-48 hours post procedure to inquire about falls or evidence of nerve injury, as well as patient satisfaction.	Neuromuscular Block n=30 Participants Comparing the incidence of adductor spasm in patients undergoing general anesthesia with neuromuscular blocking agents. Neuromuscular block: Subjects allocated to the neuromuscular block group will be monitored for the incidence of block and procedure-related adverse events. In addition to clinical observation, a Nerve Integrity Monitor (Medtronic) will be used to detect adductor spasm using continuous electromyography. Electrodes will be placed on the thigh to objectively detect and record instances of adductor spasm. One hour after arrival to PACU or when discharge criteria are met (whichever comes first), repeat dynamometer measurements and TUG tests will be performed. Patients will be called 24-48 hours post procedure to inquire about falls or evidence of nerve injury, as well as patient satisfaction.
Number of Patients With Incidence of Leg Weakness	27 Participants	22 Participants

Adverse Events

Obturator Block

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Neuromuscular 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

Dr. Jose R. Soberon, Jr.

Department of Anesthesiology, NF/SG Veterans Health System

Phone: 352-413-2317

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place