Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04591353 |
| Other study ID # |
IRB-300006163 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2021 |
| Est. completion date |
November 1, 2022 |
Study information
| Verified date |
July 2023 |
| Source |
University of Alabama at Birmingham |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Total hip arthroplasty (THA) is now the second most common joint replacement surgery in the
US due in part to an aging population. Opioid sparing analgesic treatments such as lumbar
plexus and femoral nerve blocks are effective but they carry a high risk of undesirable lower
limb motor or muscle weakness. Fascia iliaca block, on the other hand, does not consistently
provide adequate pain relief. Today, early mobilization, rehabilitation and participation in
physical therapy is an integral part of enhanced functional recovery program after THA.
Because innervation of the hip joint is complex and preservation of lower extremity motor
function is paramount, optimal regional analgesic intervention for THA has yet to be defined.
The pericapsular nerve group (PENG) block is a novel regional anesthesia technique for
providing analgesia after hip fractures and hip arthroplasties. Quality of recovery scores
are patient reported outcome measures evaluating recovery after surgery and anesthesia. The
quality of recovery-15 (QoR-15) is a validated questionnaire to assess postoperative
recovery. The aim of this single center, double blind, randomized controlled trial is to
confirm the efficacy of the PENG block for postoperative recovery after primary THA.
Methods: The participants will be randomly assigned to either PENG block group or "no Block"
group using a random number generator. The patient will be blinded to the group allocated.
The primary outcome will be the quality of recovery 15 score (QoR-15). The secondary outcomes
will be visual analog scale score of pain postoperatively, opioid requirements in first 24
hours, ambulation distance on postoperative day1 and patient satisfaction. Statistical
analysis will be performed using the student's t-test, Mann-Whitney U test, and Fisher's
exact test as appropriate per sample. A p-value of less than 0.05 will be considered
statistically significant.
Description:
As the practice of anesthesiology has grown increasingly safe, the focus has shifted to
improving quality, as evidenced by the robust spread of Enhanced Recovery after Surgery
protocols. The implications from poor quality recovery is vast, including prolonged stay in
the recovery room or hospital. The Quality of Recovery (QoR-15) questionnaire is a method to
measure five dimensions using 15 questions: physical independence, pain, comfort, patient
support, emotional state. It is an extensively validated measure of patient-assessed quality
of recovery after surgery, having been demonstrated over a variety of clinical settings.
QoR-15 scores range from 0 (extremely poor quality of recovery) to 150 (excellent). Mean time
to complete the 15-question survey is 3 minutes, a marker of its clinical utility. As we aim
to improve our perioperative care and develop approaches to improve medicine in this regard,
the QoR-15 provides a useful tool.
The effective postoperative analgesia is vital as acute surgical pain is a potential risk
factor for future chronic pain. Persistent pain after THA (more than three months) is
reported in 27% of patients and is reported to be correlated with the intensity of early
postoperative pain rather than preoperative pain levels. Utilizing regional anesthesia helps
to limit the use of opioids, however, which technique is best has yet to be determined. The
lumbar plexus blocks, lumbar epidurals, and femoral nerve blocks have been associated with
motor weakness. Fascia iliaca compartment block (FICB) has not been found to predictably
decrease pain intensity or opioid use. Quadratus lumborum (QL) block is a relatively new
regional block found to provide effective analgesia after primary THA, but it can indirectly
block lumbar plexus branches and may cause some motor weakness. It is also a deep block and
therefore contraindicated in patients on anticoagulation.
Recent anatomic studies confirmed the innervation of the anterior capsule of hip joint to be
the obturator nerve, accessory obturator nerve, and femoral nerve. These studies also
evaluated the relationship with these nerves and other bony or soft tissue landmarks visible
by ultrasound guidance. Previous studies have found histologically that the anterior capsule
has predominantly nociceptive fibers, while the posterior capsule is largely made up of
mechanoreceptors. The pericapsular nerve group (PENG) block was introduced to target and
block these articular branches providing innervation to the hip. Given the case reports
showing the efficacy of PENG blocks for hip fracture surgeries, we sought to investigate the
analgesic efficacy of PENG blocks for primary and revision THAs. The PENG block targets only
the sensory branches and not the posterior mechanoreceptors; there is a potential
motor-sparing effect which is desirable for early ambulation, better physical therapy, and
earlier discharge. The effective analgesia and early ambulation provided by such regional
anesthesia block may have positive impact on patient's mood, sleep, appetite and overall
feeling of well-being. A similar postoperative recovery study protocol has been proposed for
anterior quadratus lumborum blocks for THA. It remains unclear whether PENG block provides
sufficient analgesia and improves the quality of post-operative recovery after primary THA.
The ideal regional anesthesia technique for THA will provide adequate postoperative
analgesia, reduced opioid requirements, early ambulation and physical independence. The aim
of this single center, double blind RCT is to confirm the efficacy of PENG block for
postoperative recovery with respect to parameters mentioned above.
