QL vs PENG for Analgesia After Hip Arthroplasty

Postoperative Pain Clinical Trial

Official title:

The Impact or Quadratum Lumborum (QL) Block Versus Pericapsular Nerve Group (PENG) With Lateral Femoral Cutaneous (LFC) Nerve Blocks for Analgesia After Hip Arthroplasty: a Prospective, Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05710107
• Other study ID #: Pro00124880
• Status: Completed
• Phase: N/A
• Start date: February 7, 2023
• Est. completion date: November 12, 2023

Study information

• Verified date: March 2024
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will consist of patients 18 years and older who are undergoing elective hip replacement with planned same day discharge. The patients will be randomized to receive a PENG+LFC or QL block prior to undergoing the surgery to help with postoperative pain control. The primary goal will be assessing postoperative opioid use during the first 72 hours after surgery. Secondary outcomes will include postoperative pain scores from, 0-72 hours. Additional outcomes consist of time to first ambulation, functional and mobility outcomes, PACU duration, patient satisfaction and opioid related side effects.

Description:

1. Patients demographic data and health information will be collected including age, height, weight, and details related to injury from the medical record. Patients will also be asked to complete a set of questionnaires detailing how they feel prior to the procedure.

2. Patients will be randomly assigned to one of two groups. Group A will receive the PENG + LFC block. Group B will receive the QL block. Patients will be sedated while receiving either block.

If patients are assigned to the QL block, ultrasound technology will be used to identify appropriate structures on the side of the abdomen. An injection of lidocaine (numbing medication) into the skin will be inserted first for comfort. A second needle will be inserted into the side of the abdomen and a numbing medication called ropivacaine will be injected.\

If patients are randomized to receive PENG + LFC, ultrasound technology will be used to identify appropriate structures between the hip and groin area. An injection of lidocaine (numbing medication) into the skin will be inserted first for comfort. A needle will be inserted to the appropriate location between the hip and groin, and a numbing medication called ropivacaine will be injected. This may take more than one injection in the same area.

3. Surgery will begin shortly after the placement of the nerve block(s).

4. Before being discharged from the surgery center, patients will be asked their current pain score (0-100) and the study team will provide a detailed information sheet that includes instructions for the study follow-up period. Patients will receive a text message with a link to a questionnaire at 9:00 AM, and 3:00 PM for the first three days after surgery. This questionnaire will ask them to rate their average pain at rest and while moving in a specific time period by using a visual scale from 0-100. The study will also ask questions about the pain medication taken in that same time period. At day 7, participants will receive a survey link via text message with additional questions about recovery. If they do not wish to be contacted by text message, someone from the study team will contact them by telephone at the end of the seven days and ask them to read back the information recorded on the paper data sheet provided.

5. At approximately 2-3 weeks after surgery, and again at approximately 6 weeks after surgery a study team member will contact patients either via telephone or visit patients during their post-surgical clinic visit to complete a set of questionnaires related to their recovery. Patients will also be asked to report any side effects, urgent care/emergency room visits, or any new conditions while participating in the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: November 12, 2023
• Est. primary completion date: November 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age greater than or equal to 18 years of age

• undergoing elective hip arthroplasty with planned same day discharge

Exclusion Criteria:

• local anesthetic allergy

• subjects with a weight less than 40kg

• subjects that are unable or choose not to give informed consent

• Known preoperative substance abuse

Related Conditions & MeSH terms

• Block
• Hip Replacement
• Pain, Postoperative
• Postoperative Pain

Intervention

Other:
• PENG + LFC Block
Subjects assigned to this group will receive PENG + LFC Block
• QL Block
Subjects randomized to this group will receive a QL Block

Locations

Country	Name	City	State
United States	MUSC	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time to First Ambulation	How many minutes after anesthesia stop time patients first ambulate	From anesthesia stop time to first ambulation in minutes, assessed up to 7 days post-op.
Other	Physical, mental, and social aspects of health	The PROMIS Global Health Questionnaire will assess functional outcomes such by evaluating the patient's physical, mental, and social aspects of health.	Up to 6 weeks post-operatively
Other	Overall hip health	The HOOS Jr will assess overall Hip Health in participants.	Up to 6 weeks post-operatively
Other	Patient Satisfaction	We will be evaluating the patient's satisfaction with their post-op recovery by administering a satisfaction assessment.	0-72 hours postoperatively
Other	PACU Duration	Time patient spent in PACU	surgery end to time discharged from PACU, assessed up to 6 weeks post-op
Other	Number of opioid related side-effects	Side effects experienced from opioids	0-72 hours postoperatively
Primary	Postoperative cumulative opioid consumption	The primary outcome will be postoperative cumulative opioid consumption (in IV morphine mg equivalents: IV MME) over time, up to 72 hours postoperatively. Cumulative opioid consumption will be evaluated at PACU, and through 72 hours post-op.	0-72 hours postoperatively
Secondary	Postoperative pain score measures	Postoperative pain score measures on the visual analog scale (VAS) from 0-100 captured in the preoperative area, PACU, and through 72-hours post-op. The lower the reported pain score, the better the outcome.	0-72 hours postoperatively