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The PENG Block in Elective Hip Surgery and Its Effect on Postoperative Pain and Length of Stay.

The PENG Block in Elective Hip Surgery and Its Effect on Postoperative Pain and Length of Stay: A Multidisciplinary Prospective Randomized Double-blind Controlled Trial.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05056675
Enrollment
151
Registered
2021-09-24
Start date
2022-06-01
Completion date
2023-11-30
Last updated
2024-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

Keywords

PENG block, Postoperative pain, Elective hip surgery, Total hip arthroplasty, Surgical hip dislocation

Brief summary

Effective postoperative pain management in elective hip surgery is crucial for the patients well-being, rapid mobilisation and potential reduction of length of stay. In addition to standard intravenous pain medication, anaesthetic blocks are reportedly effective. Recently, the PENG block, a pericapsular pain block without impairment of the motor function has been introduced in literature and performed at the investigator's hospital (HFR Fribourg, Switzerland) for total hip arthroplasty and surgical hip dislocation - the two most commonly performed elective hip surgeries. As high-quality evidence on the effectiveness of this novel block is lacking, the investigator's objective is to evaluate the effectiveness of (1) patient-reported pain reduction, (2) total consumption of postoperative morphine, and the length of stay at the hospital.

Detailed description

Forty patients undergoing total hip arthroplasty and 40 patients undergoing surgical hip dislocation will be enrolled in a prospective, double-blind, controlled trial performed at the investigator's hospital. This study will be the first prospective study evaluating the potential of this pain block in elective hip surgery potentially affecting both patients' postoperative well-being and optimizing costs of the hospital by reducing length of stay.

Interventions

PROCEDUREPENG block

All patients will undergo the same preoperative, standardized protocol. Upon arrival to the operating room, patients will be placed in supine position. Routine, standard pre-medication will be applied before induction of general anesthesia. After intubation, the PENG block is performed. Under sonographic guidance using a curvilinear probe, puncture will be performed in a lateromedial direction until the needle tip reaches the plane between the iliopsoas tendon and periosteum and between the anterior inferior iliac spine and iliopubic eminence. After a negative aspiration test, the blinded test item will be injected in the plane beneath the iliopsoas muscle. Patients will be randomly assigned to receive the test item (20 mL of ropivacaine 0.5%, Naropin). The anesthesiologist and the surgeon are blinded to the product injected.

PROCEDUREPlacebo

ll patients will undergo the same preoperative, standardized protocol. Upon arrival to the operating room, patients will be placed in supine position. Routine, standard pre-medication will be applied before induction of general anesthesia. After intubation, the PENG block is performed. Under sonographic guidance using a curvilinear probe, puncture will be performed in a lateromedial direction until the needle tip reaches the plane between the iliopsoas tendon and periosteum and between the anterior inferior iliac spine and iliopubic eminence. After a negative aspiration test, the blinded test item will be injected in the plane beneath the iliopsoas muscle. Patients will be randomly assigned to receive the placebo (20 mL of NaCL 0.9%). The anesthesiologist and the surgeon are blinded to the product injected.

Sponsors

Hôpital Fribourgeois
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Intervention model description

Interdisciplinary, prospective, double-blind (participant and investigator), placebo-controlled, parallel-group study (experimental study, level of evidence I).

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* Anterior total hip arthroplasty for hip osteoarthritis * Surgical hip dislocation for femoro-acetabular impingement (type cam-/pincer) * Age 16-85 years * American Society of Anesthesiologists (ASA) physical status 1 to 3

Exclusion criteria

* Patient refusal/no informed consent * Inability to give informed consent * Lateral approach for total hip arthroplasty * Bilateral procedure * Additional osteotomies of the femur and/or acetabulum * Previous hip & pelvis surgery * Chronic opioid users * Known allergy or intolerance to medications used in the trial (local anesthetic, opioid) * Infection at the injection site * Body mass index \> 40kg/m2 * Spinal anesthesia

Design outcomes

Primary

MeasureTime frameDescription
Visual analogue scale (VAS)Reduction of postoperative pain in the first 24 hours after surgeryUsing a ruler, the score is determined by measuring the distance (cm) on the 10-cm line between the no pain anchor and the patient's mark, providing a range of scores from 0 to 10. A higher score indicates greater pain intensity

Secondary

MeasureTime frameDescription
Total morphine consumption (morphine equivalent dose)Total consumption of postoperative morphine in the first 24 hours after surgeryTotal morphine consumption in morphine equivalent dose (MED) in the fist 24 hours after surgery.
Length of stay (days)Length of stay at the hospital (in days) from the day of the surgery (day 0) to the day of discharge, up to a maximum of 7 postoperative daysThe length of hospital stay is measured in days, from the day of surgery (day 0) to the patient's discharge from the hospital. Discharge occurs up to a maximum of 7 days after surgery when the 3 following criteria are met: the scar must be dry, the pain must no longer require morphine and the patient must be able to walk with crutches

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026