Trial Outcomes & Findings for Volume Versus Concentration: Clinical Effectiveness of Single Shot Quadrates Lumborum Block Using Either a High Volume/Low Concentration or Low Volume/High Concentration Injectate for Total Hip Arthroplasty. (NCT NCT04259645)

NCT ID: NCT04259645

Last Updated: 2024-07-10

Results Overview

Opioids administered to the patient in 24 hours, measured as averaged morphine milligram equivalent

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 60 participants
• Primary outcome timeframe: 24 hours
• Results posted on: 2024-07-10

Participant Flow

Participant milestones

Measure	Low Volume Group 30 subjects randomized to Low Volume will receive unilateral Quadratus Lumborum block type II. Each block of 0.375% Bupivacaine x 20 ml Drug: Bupivacaine 0.375%: Each block of 0.375% Bupivacaine x 20 ml	High Volume Group 30 subjects randomized to High Volume will receive unilateral Quadratus lumborum block Type II. Each block of 0.375% Bupivacaine x 20 mL + Normal Saline Solution 20 mL Drug: Bupivacaine 0.375% Bupivacaine x 20 mL + Normal Saline Solution 20 mL (total 40mL)
Overall Study STARTED	29	31
Overall Study COMPLETED	29	31
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Low Volume Group n=29 Participants 30 subjects randomized to Low Volume will receive unilateral Quadratus Lumborum block type II. Each block of 0.375% Bupivacaine x 20 ml Drug: Bupivacaine 0.375%: Each block of 0.375% Bupivacaine x 20 mL	High Volume Group n=31 Participants 30 subjects randomized to High Volume will receive unilateral Quadratus lumborum block Type II. Each block of 0.375% Bupivacaine x 20 mL + Normal Saline Solution 20 mL Drug: Bupivacaine 0.375% 20 mL: Each block of 0.375% Bupivacaine x 20 mL diluted with 20mL of Normal Saline Solution	Total n=60 Participants Total of all reporting groups
Age, Continuous	63.7 years STANDARD_DEVIATION 8.1 • n=29 Participants	65.4 years STANDARD_DEVIATION 8.7 • n=31 Participants	64.55 years STANDARD_DEVIATION 8.4 • n=60 Participants
Sex: Female, Male Female	13 Participants n=29 Participants	15 Participants n=31 Participants	28 Participants n=60 Participants
Sex: Female, Male Male	16 Participants n=29 Participants	16 Participants n=31 Participants	32 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	29 participants n=29 Participants	31 participants n=31 Participants	60 participants n=60 Participants
BMI	31.0 kg/m2 STANDARD_DEVIATION 5.4 • n=29 Participants	30.6 kg/m2 STANDARD_DEVIATION 5.7 • n=31 Participants	30.8 kg/m2 STANDARD_DEVIATION 5.5 • n=60 Participants

PRIMARY outcome

Timeframe: 24 hours

Opioids administered to the patient in 24 hours, measured as averaged morphine milligram equivalent

Outcome measures

Measure	Low Volume Group n=29 Participants 30 subjects randomized to Low Volume will receive unilateral Quadratus Lumborum block type II. Each block of 0.375% Bupivacaine x 20 ml	High Volume Group n=31 Participants 30 subjects randomized to High Volume will receive unilateral Quadratus lumborum block Type II. Each block of 0.375% Bupivacaine x 20 mL + Normal Saline Solution 20 mL
Consumption of Opioids During the First 24 Hours After Surgery.	46.2 mg morphine equivalents per 24 hours Standard Deviation 25.9	35.0 mg morphine equivalents per 24 hours Standard Deviation 27.1

PRIMARY outcome

Timeframe: 3-hours

pain scores at rest at 3 hours after surgery (minimum 0 - maximum 10)

Outcome measures

Measure	Low Volume Group n=29 Participants 30 subjects randomized to Low Volume will receive unilateral Quadratus Lumborum block type II. Each block of 0.375% Bupivacaine x 20 ml	High Volume Group n=31 Participants 30 subjects randomized to High Volume will receive unilateral Quadratus lumborum block Type II. Each block of 0.375% Bupivacaine x 20 mL + Normal Saline Solution 20 mL
Pain Measurement Through VAS (Visual Analogue Score) at Rest	4.52 score on a scale Standard Deviation 2.76	4.48 score on a scale Standard Deviation 2.81

PRIMARY outcome

Timeframe: 6-hours

pain scores at rest at 6 hours after surgery (minimum 0 - maximum 10)

Outcome measures

Measure	Low Volume Group n=29 Participants 30 subjects randomized to Low Volume will receive unilateral Quadratus Lumborum block type II. Each block of 0.375% Bupivacaine x 20 ml	High Volume Group n=31 Participants 30 subjects randomized to High Volume will receive unilateral Quadratus lumborum block Type II. Each block of 0.375% Bupivacaine x 20 mL + Normal Saline Solution 20 mL
Pain Measurement Through VAS (Visual Analogue Score) at Rest	5.76 score on a scale Standard Deviation 2.71	5.08 score on a scale Standard Deviation 2.21

PRIMARY outcome

Timeframe: 12-hours

pain scores at rest at 12 hours after surgery (minimum 0 - maximum 10)

Outcome measures

Measure	Low Volume Group n=29 Participants 30 subjects randomized to Low Volume will receive unilateral Quadratus Lumborum block type II. Each block of 0.375% Bupivacaine x 20 ml	High Volume Group n=31 Participants 30 subjects randomized to High Volume will receive unilateral Quadratus lumborum block Type II. Each block of 0.375% Bupivacaine x 20 mL + Normal Saline Solution 20 mL
Pain Measurement Through VAS (Visual Analogue Score) at Rest	5.52 score on a scale Standard Deviation 2.23	5.59 score on a scale Standard Deviation 2.83

PRIMARY outcome

Timeframe: 24-hours

pain scores at rest at 24 hours after surgery (minimum 0 - maximum 10)

Outcome measures

Measure	Low Volume Group n=29 Participants 30 subjects randomized to Low Volume will receive unilateral Quadratus Lumborum block type II. Each block of 0.375% Bupivacaine x 20 ml	High Volume Group n=31 Participants 30 subjects randomized to High Volume will receive unilateral Quadratus lumborum block Type II. Each block of 0.375% Bupivacaine x 20 mL + Normal Saline Solution 20 mL
Pain Measurement Through VAS (Visual Analogue Score) at Rest	4.78 score on a scale Standard Deviation 2.53	5.50 score on a scale Standard Deviation 2.75

SECONDARY outcome

Timeframe: Post-operative 12-32 hours

Time to ambulation after surgery (ability to walk 100 feet).

Outcome measures

Measure	Low Volume Group n=29 Participants 30 subjects randomized to Low Volume will receive unilateral Quadratus Lumborum block type II. Each block of 0.375% Bupivacaine x 20 ml	High Volume Group n=31 Participants 30 subjects randomized to High Volume will receive unilateral Quadratus lumborum block Type II. Each block of 0.375% Bupivacaine x 20 mL + Normal Saline Solution 20 mL
Time to 100ft Ambulation After Surgery	1534 minutes Standard Deviation 1055	1178 minutes Standard Deviation 1219

SECONDARY outcome

Timeframe: 24 hours

Time to consumption of the first opioid after surgery.

Outcome measures

Measure	Low Volume Group n=29 Participants 30 subjects randomized to Low Volume will receive unilateral Quadratus Lumborum block type II. Each block of 0.375% Bupivacaine x 20 ml	High Volume Group n=31 Participants 30 subjects randomized to High Volume will receive unilateral Quadratus lumborum block Type II. Each block of 0.375% Bupivacaine x 20 mL + Normal Saline Solution 20 mL
Time to Consumption of the First Opioid After Surgery.	120 minutes Standard Deviation 97	165 minutes Standard Deviation 270

SECONDARY outcome

Timeframe: Post-operative day 1 to post-operative day 5

Time to hospital discharge following surgery, measured in minutes

Outcome measures

Measure	Low Volume Group n=29 Participants 30 subjects randomized to Low Volume will receive unilateral Quadratus Lumborum block type II. Each block of 0.375% Bupivacaine x 20 ml	High Volume Group n=31 Participants 30 subjects randomized to High Volume will receive unilateral Quadratus lumborum block Type II. Each block of 0.375% Bupivacaine x 20 mL + Normal Saline Solution 20 mL
Time to Hospital Discharge	1865 minutes Standard Deviation 1480	1560 minutes Standard Deviation 1491

Adverse Events

Low Volume Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

High Volume Group

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

Anna Uskova, MD

UPMC Department of Anesthesiology and Perioperative Medicine

Phone: 412-623-2167

Email: uskoaa@upmc.edu

Results disclosure agreements

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