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NCT Number: NCT05932498

Peri-capsular Nerve Group (PENG) Block and Quadratus Lumborum Block for Hip Arthroplasty

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.

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Key information

Conditions

Post Operative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Po-Kai Wang

Hualien City, Hualien, 97002, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hip surgery

Procedure

Ultrasound-guided PENG block was administered to patients undergoing hip surgery intraoperatively.

OR

Ultrasound-guided QL block was administered to patients undergoing hip surgery intraoperatively.

Primary outcomes

  1. Comparing pain scores between the PENG and QL groups immediately after surgery

    Time frame: 10 minutes after surgery

    Pain scores were assessed using a standard Visual Analog Scale (VAS), where a rating of 0 indicated the absence of pain, while a score of 10 denoted the presence of the most severe pain.

  2. Comparing pain scores between the PENG and QL groups at the 1-hour postoperative mark

    Time frame: at the 1-hour postoperative mark

    Pain scores were assessed using a standard Visual Analog Scale (VAS), where a rating of 0 indicated the absence of pain, while a score of 10 denoted the presence of the most severe pain.

  3. Comparing pain scores between the PENG and QL groups at the 12-hour postoperative mark

    Time frame: at the 12-hour postoperative mark

    Pain scores were assessed using a standard Visual Analog Scale (VAS), where a rating of 0 indicated the absence of pain, while a score of 10 denoted the presence of the most severe pain.

  4. Comparing pain scores between the PENG and QL groups at the 24-hour postoperative mark

    Time frame: at the 24-hour postoperative mark

    Pain scores were assessed using a standard Visual Analog Scale (VAS), where a rating of 0 indicated the absence of pain, while a score of 10 denoted the presence of the most severe pain.

  5. Comparing pain scores between the PENG and QL groups at the 48-hour postoperative mark

    Time frame: at the 48-hour postoperative mark

    Pain scores were assessed using a standard Visual Analog Scale (VAS), where a rating of 0 indicated the absence of pain, while a score of 10 denoted the presence of the most severe pain.

Secondary outcomes

  1. Postoperative opioid consumption

    Time frame: at the 12-, 24-, 48-hours after surgery

    Comparing the amount of parenteral opioids administered for rescue purposes as Morphine Milligram Equivalents (MME) between the PENG and QL groups at various postoperative time intervals.

  2. The quadriceps strength on surgical side

    Time frame: at the 0-, 1-, 12-, 24-, 48-, and 72-hours after surgery

    After performing PENG or QL blocks, the investigators assessed and compared the strength of the quadriceps muscles on the side that underwent hip surgery using Manual Muscle Testing (MMT) scores. MMT involves assigning scores to assess the patients' quadriceps muscle strength, ranging from 0 (no activation) to 5 (activation against resistance).

  3. Time to independently sit at the edge of the bed after surgery

    Time frame: 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

    Sitting at the edge of the bed is a functional milestone that reflects the patient's progress toward regaining mobility and independence in activities of daily living.

    The duration required to achieve sitting at the edge of the bed was measured in terms of the number of days following the surgery.

  4. Time to stand up after surgery

    Time frame: From the date of hip surgery until the patient achieves standing up, with a maximum follow-up period of 7 days

    Standing up indicates the patient's ability to bear weight on the affected hip joint and engage in activities such as walking, transferring, and performing daily tasks after hip surgery.

    The duration required to achieve standing up was measured in terms of the number of days following the surgery.

  5. Time to walk with the aid of walking devices after surgery

    Time frame: 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

    Walking with the aid of walking devices reflects the patient's ability to regain mobility and independence in walking, even if patients require assistance or support from these devices.

    The duration required to achieve walking with the aid of walking devices was measured in terms of the number of days following the surgery.

  6. Perioperative blood loss and blood transfusion

    Time frame: During the surgery and over the three-day postoperative period

    The investigators documented the amount of blood loss and the need for blood transfusion both during the surgery and in the postoperative period.

Sponsors and collaborators

Lead sponsor

Buddhist Tzu Chi General Hospital

Other

Registry information

Official study title

Peri-capsular Nerve Group Block and Quadratus Lumborum Block for Hip Arthroplasty: A Randomized Controlled Trial

Acronym: PENG

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 6, 2023
Registry last updated
Jul 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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