Does Adding an Additional Numbing Medication Injection in the Thigh Help With Pain Control After Knee Replacement Surgery?

• Sponsor: Icahn School of Medicine at Mount Sinai (Other)
• Overall Status: Completed
• CT.gov ID: NCT03326999
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Actual Duration (Months): 12.2
• Patients Per Site Per Month: 4.9

Study Details

Study Description

Brief Summary

One common anesthetic that is performed for total knee replacement surgery is spinal anesthesia with an adductor canal regional block, which involves injecting numbing medication in the thigh region for pain control after surgery. The aim of this study is to determine whether the addition of another regional block called obturator nerve block, which involves injecting numbing medication in the upper thigh region, will improve pain control after surgery while not sacrificing mobility after surgery.

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis; Knee Rheumatism	Drug: Obturator nerve regional block; Drug: Adductor canal regional block; Drug: Saline	Phase 4

Detailed Description

There is currently no consensus on the optimal strategy that provides the most effective postoperative analgesia while preserving ambulation and limiting side effects such as nausea and vomiting. The clinical team's hypothesis is that the obturator nerve block in addition to adductor canal block can target both the anterior and posterior distribution of nerves to the knee to provide superior analgesia while not limiting ambulation. To test this hypothesis, the clinical team will compare the rate of IV opioid consumption in patients who receive a combination of adductor canal block and obturator nerve block at the surgical site versus patients who receive adductor canal block alone.

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized controlled trial with two arms: one arm will receive adductor canal block and obturator nerve block with the local anesthetic bupivacaine; second arm will receive adductor canal block with bupivacaine and obturator nerve block with saline.Randomized controlled trial with two arms: one arm will receive adductor canal block and obturator nerve block with the local anesthetic bupivacaine; second arm will receive adductor canal block with bupivacaine and obturator nerve block with saline.
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Evaluating the Addition of Obturator Nerve Block to Adductor Canal Block for Total Knee Arthroplasty
• Actual Study Start Date: Dec 11, 2017
• Actual Primary Completion Date: Dec 18, 2018
• Actual Study Completion Date: Dec 18, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Investigational arm Patients in this arm will receive adductor canal regional block with bupivacaine and obturator nerve regional block with bupivacaine	Drug: Obturator nerve regional block; Obturator nerve regional block involves the injection of a local anesthetic called bupivacaine into the upper thigh.; Other Names: bupivacaine ; Drug: Adductor canal regional block; Adductor canal regional block, which involves injecting numbing medication in the thigh region for pain control.
Sham Comparator: Control arm Patients in this arm will receive adductor canal regional block with bupivacaine and obturator nerve regional block with saline	Drug: Adductor canal regional block; Adductor canal regional block, which involves injecting numbing medication in the thigh region for pain control.; Drug: Saline; Saline as placebo comparator

Outcome Measures

Primary Outcome Measures

1. Morphine Equivalence Consumption [up to 24 hours after surgery]

   Total amount of opioids consumed

Secondary Outcome Measures

1. Pain Score [1, 6, 12, and 24 hours after surgery]

   Likert scale ranging from 0-10 - 0 being no pain, and 10 being the worst pain ever experienced

2. Number of Participants With Nausea or Vomiting [up to 24 hours after surgery]

   Yes or No responses when the subject is asked if the subject is feeling nauseous or has vomited

3. Time to Ambulation [on postoperative day 1 after surgery]

   The length of time that it takes before the patient is first able to walk with assistance after surgery as assessed by a physical therapist.

4. Time to Breakthrough Pain Medication [up to post operative day 2 after surgery]

   Time before pain medication needed for breakthrough pain

5. Analgesia Satisfaction Score [2 weeks after surgery]

   Analgesia Satisfaction Score - Full scale from 0-10 with higher score indicating higher satisfaction.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients scheduled to undergo total knee arthroplasty

• Planned use of regional anesthesia for procedure

• Willing and able to provide informed consent

Exclusion Criteria:

• Patients on immunosuppressive therapy

• Patients with history of diabetes

• Patients with lower limb neuropathy

• Patients with history of chronic opioid use for > 3 months, including but not limited to, fentanyl, morphine, oxycodone, methadone

• Patients with known allergy or intolerance to any drug used in the study

• Patients with history of alcohol or drug abuse

• Patients with history of intolerance of nonsteroidal anti-inflammatory drugs

• Patients with hepatic or renal insufficiency

• ASA score of 4 or greater

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Icahn School of Medicine at Mount Sinai	New York	New York	United States	10029

Sponsors and Collaborators

• Icahn School of Medicine at Mount Sinai

Investigators

• Principal Investigator: Christina Jeng, MD, Icahn School of Medicine at Mount Sinai

Study Documents (Full-Text)

• Study Protocol - Sep 29, 2017
• Statistical Analysis Plan - Sep 29, 2017

More Information

Publications

• Runge C, Børglum J, Jensen JM, Kobborg T, Pedersen A, Sandberg J, Mikkelsen LR, Vase M, Bendtsen TF. The Analgesic Effect of Obturator Nerve Block Added to a Femoral Triangle Block After Total Knee Arthroplasty: A Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Jul-Aug;41(4):445-51. doi: 10.1097/AAP.0000000000000406.

• Responsible Party: Christina Jeng, Christina Jeng MD Assistant Professor, Icahn School of Medicine at Mount Sinai
• ClinicalTrials.gov Identifier: NCT03326999
• Other Study ID Numbers: GCO 17-2153
• First Posted: Oct 31, 2017
• Last Update Posted: Sep 30, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Christina Jeng, Christina Jeng MD Assistant Professor, Icahn School of Medicine at Mount Sinai: adductor canal regional block; obturator nerve regional block; total knee arthroplasty; knee replacement surgery; Knee rheumatoid arthritis
• Additional relevant MeSH terms: Osteoarthritis, Knee; Rheumatic Diseases; Bupivacaine

Study Results

Participant Flow

Recruitment Details	Recruitment began in October with enrollment from December 2017 through December 2018.

Arm/Group Title	Investigational Arm	Control Arm
Arm/Group Description	Patients in this arm received adductor canal regional block with bupivacaine and obturator nerve regional block with bupivacaine	Patients in this arm received adductor canal regional block with bupivacaine and obturator nerve regional block with saline
Period Title: Overall Study
STARTED	30	30
COMPLETED	30	30
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Bupivacaine Arm	Saline Control Arm	Total
Arm/Group Description	Patients in this arm received adductor canal regional block with bupivacaine and obturator nerve regional block with bupivacaine	Patients in this arm received adductor canal regional block with bupivacaine and obturator nerve regional block with saline	Total of all reporting groups
Overall Participants	30	30	60
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	67.9 (7.5)	66.7 (7.3)	67.3 (7.4)
Sex: Female, Male (Count of Participants)
Female	17 56.7%	18 60%	35 58.3%
Male	13 43.3%	12 40%	25 41.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	4 13.3%	7 23.3%	11 18.3%
White	18 60%	18 60%	36 60%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	8 26.7%	5 16.7%	13 21.7%
Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	30.72 (4.85)	28.65 (5.05)	29.68 (5.02)

Outcome Measures

1. Primary Outcome

Title	Morphine Equivalence Consumption
Description	Total amount of opioids consumed
Time Frame	up to 24 hours after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bupivacaine Arm	Saline Control Arm
Arm/Group Description	Patients in this arm received adductor canal regional block with bupivacaine and obturator nerve regional block with bupivacaine	Patients in this arm received adductor canal regional block with bupivacaine and obturator nerve regional block with saline
Measure Participants	30	30
Mean (Standard Deviation) [MME]	12.6 (6.37)	18.85 (7.74)

2. Secondary Outcome

Title	Pain Score
Description	Likert scale ranging from 0-10 - 0 being no pain, and 10 being the worst pain ever experienced
Time Frame	1, 6, 12, and 24 hours after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bupivacaine Arm	Saline Control Arm
Arm/Group Description	Patients in this arm received adductor canal regional block with bupivacaine and obturator nerve regional block with bupivacaine	Patients in this arm received adductor canal regional block with bupivacaine and obturator nerve regional block with saline
Measure Participants	30	30
1 hour	0.17 (0.64)	0.23 (1.28)
6 hours	2.27 (2.82)	2.77 (2.71)
12 hours	4.10 (2.92)	5.13 (2.22)
24 hours	6.10 (2.66)	7.00 (2.24)

3. Secondary Outcome

Title	Number of Participants With Nausea or Vomiting
Description	Yes or No responses when the subject is asked if the subject is feeling nauseous or has vomited
Time Frame	up to 24 hours after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bupivacaine Arm	Saline Control Arm
Arm/Group Description	Patients in this arm received adductor canal regional block with bupivacaine and obturator nerve regional block with bupivacaine	Patients in this arm received adductor canal regional block with bupivacaine and obturator nerve regional block with saline
Measure Participants	30	30
Count of Participants [Participants]	11 36.7%	16 53.3%

4. Secondary Outcome

Title	Time to Ambulation
Description	The length of time that it takes before the patient is first able to walk with assistance after surgery as assessed by a physical therapist.
Time Frame	on postoperative day 1 after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bupivacaine Arm	Saline Control Arm
Arm/Group Description	Patients in this arm received adductor canal regional block with bupivacaine and obturator nerve regional block with bupivacaine	Patients in this arm received adductor canal regional block with bupivacaine and obturator nerve regional block with saline
Measure Participants	30	30
Mean (Standard Deviation) [hours]	8.98 (8.13)	7.87 (8.49)

5. Secondary Outcome

Title	Time to Breakthrough Pain Medication
Description	Time before pain medication needed for breakthrough pain
Time Frame	up to post operative day 2 after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bupivacaine Arm	Saline Control Arm
Arm/Group Description	Patients in this arm received adductor canal regional block with bupivacaine and obturator nerve regional block with bupivacaine	Patients in this arm received adductor canal regional block with bupivacaine and obturator nerve regional block with saline
Measure Participants	30	30
Mean (Standard Deviation) [minutes]	872.54 (1044.07)	510.13 (420.69)

6. Secondary Outcome

Title	Analgesia Satisfaction Score
Description	Analgesia Satisfaction Score - Full scale from 0-10 with higher score indicating higher satisfaction.
Time Frame	2 weeks after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bupivacaine Arm	Saline Control Arm
Arm/Group Description	Patients in this arm received adductor canal regional block with bupivacaine and obturator nerve regional block with bupivacaine	Patients in this arm received adductor canal regional block with bupivacaine and obturator nerve regional block with saline
Measure Participants	30	30
Mean (Standard Deviation) [score on a scale]	9.24 (0.93)	8.59 (2.08)

Adverse Events

Time Frame	2 weeks post surgery
Arm/Group Title	Investigational Arm		Control Arm
Arm/Group Description	Patients in this arm will receive adductor canal regional block with bupivacaine and obturator nerve regional block with bupivacaine		Patients in this arm will receive adductor canal regional block with bupivacaine and obturator nerve regional block with saline
All Cause Mortality
	Investigational Arm		Control Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)
Serious Adverse Events
	Investigational Arm		Control Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)
Other (Not Including Serious) Adverse Events
	Investigational Arm		Control Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE 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.