Clinical trial NCT05710107: QL vs PENG for Analgesia After Hip Arthroplasty
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Block
Hip Replacement
Postoperative Pain
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2023-02-02
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative Cumulative Opioid Consumption
timeFrame: 0-72 hours postoperatively
Secondary outcomes:
measure: Average Postoperative Pain Score
timeFrame: 0-72 hours postoperatively
Other outcomes:
measure: Time to First Ambulation
timeFrame: From anesthesia stop time to first ambulation in minutes, assessed up to 7 days post-op.
measure: PROMIS Physical Health
timeFrame: Up to 6 weeks post-operatively
measure: Overall Hip Health
timeFrame: Up to 6 weeks post-operatively
measure: PACU Duration
timeFrame: surgery end to time discharged from PACU, assessed up to 6 weeks post-op
measure: PROMIS Mental Health
timeFrame: up to 6 weeks post-operatively
Locations:
city: Charleston
country: United States
facility: MUSC
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Ellen Hay, MD
role: PRINCIPAL_INVESTIGATOR
References: