LPB Hip Scope: Lumbar Plexus Block for Postoperative Pain Control After Hip Arthroscopy. A Randomized Controlled Trial

• Sponsor: Hospital for Special Surgery, New York (Other)
• Overall Status: Completed
• CT.gov ID: NCT01286805
• Collaborator: New York Presbyterian Hospital (Other)
• Enrollment: 83
• Locations: 2
• Arms: 2
• Duration (Months): 12
• Patients Per Site: 41.5
• Patients Per Site Per Month: 3.5

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether the use of a lumbar plexus block for arthroscopic hip surgery is superior to oral and intravenous opioid pain medications alone in treating pain. In addition, the study will examine whether lumbar plexus blocks reduce the total amount of pain medication needed, and therefore reduce the side effects of these medicines and increase patient satisfaction. It is hypothesized that addition of the lumbar plexus block will significantly reduce patients' postoperative pain.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Procedure: Lumbar Plexus Blockade; Procedure: Control	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 83 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Lumbar Plexus Block for Postoperative Pain Control After Hip Arthroscopy. A Randomized Controlled Trial
• Study Start Date: May 1, 2010
• Actual Primary Completion Date: Oct 1, 2010
• Actual Study Completion Date: May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lumbar Plexus Blockade + CSE The study group will receive a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural.	Procedure: Lumbar Plexus Blockade; The lumbar plexus block will be dosed with 30 milliliters of 0.25% bupivacaine with 1:200,000 epinephrine; Other Names: Marcaine
Placebo Comparator: Control Group The control group will receive only a combined spinal-epidural.	Procedure: Control; The control group will receive only a combined spinal-epidural.

Outcome Measures

Primary Outcome Measures

1. Numeric Rating Scale (NRS) Pain at Rest (0-10) on Day of Surgery Prior to Discharge [Day of surgery prior to discharge]

   The Numeric Rating Scale was used to ask patients to rate their pain at rest on a scale of 0 to 10, 0 = no pain and 10 = worst pain imaginable.

Secondary Outcome Measures

1. Readiness to Discharge From Post-Anesthesia Care Unit (PACU) [Day of surgery prior to discharge]

   Time to readiness for discharge from the PACU. Patients were considered ready for PACU discharge when they met the following criteria: a) Awake, alert, oriented and responsive b) Minimal pain, Numeric Rating Scale < 5/10 (0 = no pain, 10 = worst imaginable pain) (parenteral [injected] medications not required) c) Vital signs stable d) No active bleeding e) Minimal or no nausea f) Not vomiting, tolerating oral intake g) Oxygen saturation > 94% (or baseline) on room air h) Patient has urinated.

2. Narcotic Pain Medication Needed [Day of surgery prior to discharge]

3. Incidence of Nausea [Day of surgery prior to discharge]

   The number of participants with nausea.

4. Incidence of Vomiting [Day of surgery prior to discharge]

   The number of participants who vomited.

5. Requirement of Antiemetic Rescue [Day of surgery prior to discharge]

   The number of participants who needed medication to treat their nausea and vomiting.

6. Patient Satisfaction [First 24 hours after surgery]

   Patient Satisfaction (0-10; 0 = very dissatisfied, 10 = very satisfied)

7. Quality of Recovery (QoR-40) Physical Comfort Dimension [First 24 hours after surgery]

   Assessment of Physical Comfort (minimum score = 12, maximum score = 60). Higher values represent a better outcome

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• American Society of Anesthesiologists (ASA) Class 1-3

• Patients aged 18 to 65 years

• Patients scheduled for primary, unilateral arthroscopic hip surgery by Dr. Kelly, Dr. Coleman, or Dr. Anil Ranawat

• Planned use of neuraxial anesthesia

• Body Mass Index less than 35

• Ability to follow study protocol

Exclusion Criteria:

• Chronic opioid use (defined as daily or almost daily use of opioids for >3 months)

• Contraindication to combined spinal-epidural anesthesia including but not limited to bleeding disorder, use of clinically relevant anticoagulant or antiplatelet medications, and anatomic abnormalities.

• Contraindication to lumbar plexus block including but not limited to bleeding disorder, use of clinically relevant anticoagulant or antiplatelet medications, and anatomic abnormalities.

• Infection at the injection site(s)

• Allergy to any of the study medications

• Contraindication to a short course of NSAIDs (renal failure, intolerance)

• ASA Class 4-5

• Patient refusal

• Patients younger than 18 years old and older than 65

• Patients with any known indwelling hardware of the lumbar spine.

• Patients with a peripheral neuropathy of the surgical extremity

• Non-English speaking patients

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital for Special Surgery	New York	New York	United States	10021
2	New York Presbyterian Hospital	New York	New York	United States	10065

Sponsors and Collaborators

• Hospital for Special Surgery, New York
• New York Presbyterian Hospital

Investigators

• Principal Investigator: Jacques T YaDeau, M.D., Ph.D., Hospital for Special Surgery, New York

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• This is the link for the Hospital for Special Surgery website

Publications

None provided.

• Responsible Party: Hospital for Special Surgery, New York
• ClinicalTrials.gov Identifier: NCT01286805
• Other Study ID Numbers: 10038
• First Posted: Jan 31, 2011
• Last Update Posted: Jun 5, 2013
• Last Verified: May 1, 2013

• Additional relevant MeSH terms: Pain, Postoperative; Bupivacaine

Study Results

Participant Flow

Arm/Group Title	Lumbar Plexus Blockade + CSE	Control Group
Arm/Group Description	The study group received a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural.	The control group received only a combined spinal-epidural.
Period Title: Overall Study
STARTED	41	42
COMPLETED	41	41
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	Lumbar Plexus Blockade + CSE	Control Group	Total
Arm/Group Description	The study group received a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural.	The control group received only a combined spinal-epidural.	Total of all reporting groups
Overall Participants	41	41	82
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	33 (11)	37 (11)	35 (11)
Sex: Female, Male (Count of Participants)
Female	21 51.2%	20 48.8%	41 50%
Male	20 48.8%	21 51.2%	41 50%

Outcome Measures

1. Primary Outcome

Title	Numeric Rating Scale (NRS) Pain at Rest (0-10) on Day of Surgery Prior to Discharge
Description	The Numeric Rating Scale was used to ask patients to rate their pain at rest on a scale of 0 to 10, 0 = no pain and 10 = worst pain imaginable.
Time Frame	Day of surgery prior to discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lumbar Plexus Blockade + CSE	Control Group
Arm/Group Description	The study group received a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural.	The control group received only a combined spinal-epidural.
Measure Participants	41	41
Mean (Standard Deviation) [units on a scale]	3.3 (2.2)	4.2 (1.8)

2. Secondary Outcome

Title	Readiness to Discharge From Post-Anesthesia Care Unit (PACU)
Description	Time to readiness for discharge from the PACU. Patients were considered ready for PACU discharge when they met the following criteria: a) Awake, alert, oriented and responsive b) Minimal pain, Numeric Rating Scale < 5/10 (0 = no pain, 10 = worst imaginable pain) (parenteral [injected] medications not required) c) Vital signs stable d) No active bleeding e) Minimal or no nausea f) Not vomiting, tolerating oral intake g) Oxygen saturation > 94% (or baseline) on room air h) Patient has urinated.
Time Frame	Day of surgery prior to discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lumbar Plexus Blockade + CSE	Control Group
Arm/Group Description	The study group received a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural.	The control group received only a combined spinal-epidural.
Measure Participants	41	41
Mean (Standard Deviation) [minutes]	216 (86)	187 (59)

3. Secondary Outcome

Title	Narcotic Pain Medication Needed
Time Frame	Day of surgery prior to discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lumbar Plexus Blockade + CSE	Control Group
Arm/Group Description	The study group received a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural.	The control group received only a combined spinal-epidural.
Measure Participants	41	41
Mean (Standard Deviation) [equivalents milligrams oral morphine]	21 (17)	29 (21)

4. Secondary Outcome

Title	Incidence of Nausea
Description	The number of participants with nausea.
Time Frame	Day of surgery prior to discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lumbar Plexus Blockade + CSE	Control Group
Arm/Group Description	The study group received a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural.	The control group received only a combined spinal-epidural.
Measure Participants	41	41
Number [participants]	14 34.1%	8 19.5%

5. Secondary Outcome

Title	Incidence of Vomiting
Description	The number of participants who vomited.
Time Frame	Day of surgery prior to discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lumbar Plexus Blockade + CSE	Control Group
Arm/Group Description	The study group received a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural.	The control group received only a combined spinal-epidural.
Measure Participants	41	41
Number [participants]	1 2.4%	3 7.3%

6. Secondary Outcome

Title	Requirement of Antiemetic Rescue
Description	The number of participants who needed medication to treat their nausea and vomiting.
Time Frame	Day of surgery prior to discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lumbar Plexus Blockade + CSE	Control Group
Arm/Group Description	The study group received a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural.	The control group received only a combined spinal-epidural.
Measure Participants	41	41
Number [participants]	5 12.2%	5 12.2%

7. Secondary Outcome

Title	Patient Satisfaction
Description	Patient Satisfaction (0-10; 0 = very dissatisfied, 10 = very satisfied)
Time Frame	First 24 hours after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lumbar Plexus Blockade + CSE	Control Group
Arm/Group Description	The study group received a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural.	The control group received only a combined spinal-epidural.
Measure Participants	41	41
Mean (Standard Deviation) [units on a scale]	8.6 (1.6)	7.9 (2.5)

8. Secondary Outcome

Title	Quality of Recovery (QoR-40) Physical Comfort Dimension
Description	Assessment of Physical Comfort (minimum score = 12, maximum score = 60). Higher values represent a better outcome
Time Frame	First 24 hours after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lumbar Plexus Blockade + CSE	Control Group
Arm/Group Description	The study group received a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural.	The control group received only a combined spinal-epidural.
Measure Participants	41	41
Mean (Standard Deviation) [QoR-40 Physical Comfort score]	53 (4.3)	52 (7.4)

Adverse Events

Arm/Group Title	Lumbar Plexus Blockade + CSE		Control Group
Arm/Group Description	The study group received a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural.		The control group received only a combined spinal-epidural.
All Cause Mortality
	Lumbar Plexus Blockade + CSE		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Lumbar Plexus Blockade + CSE		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/42 (7.1%)		2/41 (4.9%)
Gastrointestinal disorders
Admission for nausea	0/42 (0%)	0	1/41 (2.4%)	1
Injury, poisoning and procedural complications
Admission for epidural spread	1/42 (2.4%)	1	0/41 (0%)	0
Musculoskeletal and connective tissue disorders
Fall	2/42 (4.8%)	2	0/41 (0%)	0
Respiratory, thoracic and mediastinal disorders
Admission for oxygen desaturation	0/42 (0%)	0	1/41 (2.4%)	1
Other (Not Including Serious) Adverse Events
	Lumbar Plexus Blockade + CSE		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/42 (0%)		0/41 (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.