Trial Outcomes & Findings for Lumbar Plexus Block for Postoperative Pain Control After Hip Arthroscopy. A Randomized Controlled Trial (NCT NCT01286805)

NCT ID: NCT01286805

Last Updated: 2013-06-05

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 83 participants
• Primary outcome timeframe: Day of surgery prior to discharge
• Results posted on: 2013-06-05

Participant Flow

Participant milestones

Measure	Lumbar Plexus Blockade + CSE 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.	Control Group The control group received only a combined spinal-epidural.
Overall Study STARTED	41	42
Overall Study COMPLETED	41	41
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Lumbar Plexus Blockade + CSE n=41 Participants 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.	Control Group n=41 Participants The control group received only a combined spinal-epidural.	Total n=82 Participants Total of all reporting groups
Age Continuous	33 years STANDARD_DEVIATION 11 • n=5 Participants	37 years STANDARD_DEVIATION 11 • n=7 Participants	35 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	20 Participants n=7 Participants	41 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	21 Participants n=7 Participants	41 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Lumbar Plexus Blockade + CSE n=41 Participants 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.	Control Group n=41 Participants The control group received only a combined spinal-epidural.
Numeric Rating Scale (NRS) Pain at Rest (0-10) on Day of Surgery Prior to Discharge	3.3 units on a scale Standard Deviation 2.2	4.2 units on a scale Standard Deviation 1.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Lumbar Plexus Blockade + CSE n=41 Participants 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.	Control Group n=41 Participants The control group received only a combined spinal-epidural.
Readiness to Discharge From Post-Anesthesia Care Unit (PACU)	216 minutes Standard Deviation 86	187 minutes Standard Deviation 59

SECONDARY outcome

Timeframe: Day of surgery prior to discharge

Outcome measures

Measure	Lumbar Plexus Blockade + CSE n=41 Participants 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.	Control Group n=41 Participants The control group received only a combined spinal-epidural.
Narcotic Pain Medication Needed	21 equivalents milligrams oral morphine Standard Deviation 17	29 equivalents milligrams oral morphine Standard Deviation 21

SECONDARY outcome

Timeframe: Day of surgery prior to discharge

The number of participants with nausea.

Outcome measures

Measure	Lumbar Plexus Blockade + CSE n=41 Participants 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.	Control Group n=41 Participants The control group received only a combined spinal-epidural.
Incidence of Nausea	14 participants	8 participants

SECONDARY outcome

Timeframe: Day of surgery prior to discharge

The number of participants who vomited.

Outcome measures

Measure	Lumbar Plexus Blockade + CSE n=41 Participants 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.	Control Group n=41 Participants The control group received only a combined spinal-epidural.
Incidence of Vomiting	1 participants	3 participants

SECONDARY outcome

Timeframe: Day of surgery prior to discharge

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

Outcome measures

Measure	Lumbar Plexus Blockade + CSE n=41 Participants 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.	Control Group n=41 Participants The control group received only a combined spinal-epidural.
Requirement of Antiemetic Rescue	5 participants	5 participants

SECONDARY outcome

Timeframe: First 24 hours after surgery

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

Outcome measures

Measure	Lumbar Plexus Blockade + CSE n=41 Participants 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.	Control Group n=41 Participants The control group received only a combined spinal-epidural.
Patient Satisfaction	8.6 units on a scale Standard Deviation 1.6	7.9 units on a scale Standard Deviation 2.5

SECONDARY outcome

Timeframe: First 24 hours after surgery

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

Outcome measures

Measure	Lumbar Plexus Blockade + CSE n=41 Participants 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.	Control Group n=41 Participants The control group received only a combined spinal-epidural.
Quality of Recovery (QoR-40) Physical Comfort Dimension	53 QoR-40 Physical Comfort score Standard Deviation 4.3	52 QoR-40 Physical Comfort score Standard Deviation 7.4

Adverse Events

Lumbar Plexus Blockade + CSE

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Lumbar Plexus Blockade + CSE n=42 participants at risk 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.	Control Group n=41 participants at risk The control group received only a combined spinal-epidural.
Gastrointestinal disorders Admission for nausea	0.00% 0/42	2.4% 1/41 • Number of events 1
Respiratory, thoracic and mediastinal disorders Admission for oxygen desaturation	0.00% 0/42	2.4% 1/41 • Number of events 1
Musculoskeletal and connective tissue disorders Fall	4.8% 2/42 • Number of events 2	0.00% 0/41
Injury, poisoning and procedural complications Admission for epidural spread	2.4% 1/42 • Number of events 1	0.00% 0/41

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jacques YaDeau

Hospital for Special Surgery

Phone: 212-606-1206

Email: yadeauj@hss.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place