Clinical trial NCT05932498: Peri-capsular Nerve Group (PENG) Block and Quadratus Lumborum Block for Hip Arthroplasty
Official title: Peri-capsular Nerve Group Block and Quadratus Lumborum Block for Hip Arthroplasty: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Operative Pain
Keywords: postoperative pain
nerve block
regional analgesia
Lead sponsor: Buddhist Tzu Chi General Hospital
Sponsor class: OTHER
First posted: 2023-07-06
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: one group is that participants receive PENG block and another group is that participants receive QL block for postoperative pain control.
Primary purpose: TREATMENT

Brief summary: The goal of this randomized controlled clinical trial is to compare peri-capsular nerve group (PENG) block and quadratus lumborum (QL) block in participants who receive hip arthroplasty. The main question aims to answer is comparing the pain score among participants who receive PENG or QL block.

Participants will be randomized and assigned into two groups. Participants will receive a PENG block in the PENG group and receive a QL block in the QL group. After participants receive hip arthroplasty, the investigators will compare the two groups to see if there is a difference of pain score, postoperative opioid consumption, sensation and motor function after nerve blocks, progress of functional recovery in lower limbs, intraoperative and postoperative complications.

Detailed description: Hip joint surgery is a common orthopedic procedure that effectively improves patients' quality of life and functional status. However, postoperative pain is a common issue that can affect patients' activity, increase the risk of venous thromboembolism due to venous stasis, and prolong recovery time, hospital stay, and expenses. Therefore, controlling postoperative pain after hip joint surgery is crucial to reduce its side effects. Nerve block is one of the methods for postoperative pain management after hip joint surgery and has been proven effective in reducing pain levels, decreasing opioid use, and its side effects.

Traditionally, the quadratus lumborum nerve block (QL block) is used for pain relief during abdominal surgery, but it can also be used for lower limb surgery due to its extensive application. Compared to other nerve blocks, QL block may provide better postoperative pain relief, have less impact on hip joint activity and quadriceps muscle contraction, and reduce opioid use and hospital stay.

The peri-capsular nerve group block (PENG block) is another nerve block technique performed by injecting anesthetic analgesics around the hip joint capsule using ultrasound and blocking surrounding nerves with a larger dose. In a clinical study, PENG block significantly reduced static and dynamic pain scores in five patients with femoral neck fractures after 30 minutes of the nerve block. PENG block has advantages in injection and identification of anatomical structures compared to QL block, but their analgesic effects have not been directly compared. Therefore, clinical trials of both techniques are needed.

Eligibility criteria: Inclusion Criteria:

* Patients who are 20 years of age or older (including 20 years of age).
* Non-emergency hip arthroplasty surgery.
* Able to understand and cooperate with preoperative and postoperative data collection.
* Grade one to three in the American Society of Anesthesiologists (ASA) physical status classification.

Exclusion Criteria:

* Under 20 years of age.
* A known allergy to the study medication (ropivacaine).
* Liver cirrhosis classified as Child Pugh Score C.
* Dementia or mental illness.
* Unable to assess their own pain level.
* Patients who have been using opioid drugs for a prolonged period.
* Having a history of drug or alcohol abuse within the last 6 months.
* Having serious illness and at a risk of imminent mortality.

Primary outcomes:
measure: Comparing pain scores between the PENG and QL groups immediately after surgery
timeFrame: 10 minutes after surgery
measure: Comparing pain scores between the PENG and QL groups at the 1-hour postoperative mark
timeFrame: at the 1-hour postoperative mark
measure: Comparing pain scores between the PENG and QL groups at the 12-hour postoperative mark
timeFrame: at the 12-hour postoperative mark
measure: Comparing pain scores between the PENG and QL groups at the 24-hour postoperative mark
timeFrame: at the 24-hour postoperative mark
measure: Comparing pain scores between the PENG and QL groups at the 48-hour postoperative mark
timeFrame: at the 48-hour postoperative mark
Secondary outcomes:
measure: Postoperative opioid consumption
timeFrame: at the 12-, 24-, 48-hours after surgery
measure: The quadriceps strength on surgical side
timeFrame: at the 0-, 1-, 12-, 24-, 48-, and 72-hours after surgery
measure: Time to independently sit at the edge of the bed after surgery
timeFrame: From the date of hip surgery until the patient achieves independent sitting at the edge of the bed, with a maximum follow-up period of 7 days
measure: Time to stand up after surgery
timeFrame: From the date of hip surgery until the patient achieves standing up, with a maximum follow-up period of 7 days
measure: Time to walk with the aid of walking devices after surgery
timeFrame: From the date of hip surgery until the patient achieves walking with the aid of walking devices, with a maximum follow-up period of 7 days
measure: Perioperative blood loss and blood transfusion
timeFrame: During the surgery and over the three-day postoperative period
Other outcomes:
Locations:
city: Hualien City
country: Taiwan
facility: Po-Kai Wang
state: Hualien
Study officials:
affiliation: Hualien Tzu Chi General Hospital
name: Po-Kai Wang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Min BW, Kim Y, Cho HM, Park KS, Yoon PW, Nho JH, Kim SM, Lee KJ, Moon KH. Perioperative Pain Management in Total Hip Arthroplasty: Korean Hip Society Guidelines. Hip Pelvis. 2016 Mar;28(1):15-23. doi: 10.5371/hp.2016.28.1.15. Epub 2016 Mar 31.
citation: Ueshima H, Otake H, Lin JA. Ultrasound-Guided Quadratus Lumborum Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:2752876. doi: 10.1155/2017/2752876. Epub 2017 Jan 3.
citation: La Colla L, Ben-David B, Merman R. Quadratus Lumborum Block as an Alternative to Lumbar Plexus Block for Hip Surgery: A Report of 2 Cases. A A Case Rep. 2017 Jan 1;8(1):4-6. doi: 10.1213/XAA.0000000000000406.
citation: Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.