NCT06806865

Brief Summary

Adequate pain management after total hip arthroplasty (THA) is crucial for early ambulation and patient satisfaction. However, due to the hip joint's innervation complexity, the optimal regional analgesia technique for THA remains controversial. Total hip arthroplasties are critical surgeries that can take steps to improve the quality of life and functional status of patients who do not respond to conservative treatments. However, patients may present with intense pain in the immediate postoperative period, resulting in inactivity, increased risk of complications, and greater opioid consumption, resulting in adverse effects and prolonged hospital stay. The challenging management of pain is explained by the complex innervation of the hip joint, in which the articular branches of the femoral, obturator, and accessory obturator nerves are responsible for the sensory innervation of the anterior capsule. This randomized clinical trial compares the analgesic efficacy of FICB and PENG block following THA. Our preliminary results will be postoperative pain scores. As our anesthesia clinic, we routinely perform these known methods after surgery in these cases. Traditional intravenous analgesia methods cause many undesirable side effects depending on the type of opioid used, and they are insufficient compared to regional anesthesia methods.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable postoperative-pain

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2024

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

December 30, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 4, 2025

Completed
Last Updated

June 5, 2025

Status Verified

May 1, 2025

Enrollment Period

1.8 years

First QC Date

December 30, 2024

Last Update Submit

May 31, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • VAS scores

    The Visual Analogue Scale (VAS) measures pain intensity. It consists of a 10 cm line with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could be'). Ask the patient to rate their current level of pain by placing a mark on the line. VAS scores at rest and during movement will be recorded at 0 hours (PACU), and subsequently at 2, 6, 12, and 24 hours while the patient is in the orthopedic clinic.

    up to 24 hours after recovery unit

Secondary Outcomes (4)

  • Total patient-controlled analgesia (PCA) consumption for 24 hours postoperatively

    Up to 24 hours

  • intraoperative blood pressure

    from the beginning of anesthesia induction to the leaving the recovery unit

  • need for additional analgesia or rescue analgesia

    up to 24 hours after surgery

  • intraoperative heart rate

    from the beginning of anesthesia induction up to leaving the recovery unit

Study Arms (2)

PENG Group (periarticular nerve group)

ACTIVE COMPARATOR

Continuous PENG block is the group to be applied.

Procedure: Periarticular nerve group block (PENG)

SIFICB Group (supra-inguinal fascia iliaca compartment block)

ACTIVE COMPARATOR

Continuous supra-inguinal fascia iliaca compartment block is the group to be applied.

Procedure: Continuous supra-inguinal fascia iliaca compartment block (SIFICB)

Interventions

The pericapsular nerve group (PENG) block targets the nerves that supply the hip capsule. The continuous PENG block will be applied immediately after general anesthesia is given to the participants under ultrasound guidance. 30 ml of 0.25% bupivacaine will be used.

PENG Group (periarticular nerve group)

The supra-inguinal fascia iliaca compartment block (SIFICB) targets the femoral, lateral femoral cutaneous, and obturator nerves. Under ultrasound guidance, 30 mL of 0.25% bupivacaine is administered, followed by catheter placement for continuous infusion at 5 mL/h.

SIFICB Group (supra-inguinal fascia iliaca compartment block)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing hip replacement for the first time
  • Patients aged 18-65 years, ASAI-II (American Society of Anesthesiology classification)
  • Patients without primary cancer and/or patients without metastatic bone fractures
  • Patients without allergy to local anaesthetics
  • Patients with an intellectual level that can use patient-controlled analgesia devices
  • Patients with a standard bleeding profile
  • Patients who gave written consent to participate in the study

You may not qualify if:

  • patients who have had a hip replacement and/or revision
  • patients who have primary cancer and/or fractures due to bone metastasis
  • patients who have a local anaesthetic allergy and/or a history of it
  • patients who are not intellectually competent enough to use a patient-controlled anesthesia device
  • patients who have undergone reoperation due to any surgical complication (bleeding, etc.) within 24 hours after surgery
  • patients who did not give written consent to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Namık Kemal Üniversitesi

Tekirdağ, Süleymanpasa, 59030, Turkey (Türkiye)

Location

Related Publications (1)

  • Baran O, Sahin A, Arar C. Comparative analysis of continuous pericapsular nerve group block and supra-inguinal fascia iliaca compartment block for postoperative analgesia in total hip arthroplasty: a randomized controlled trial. J Orthop Surg Res. 2025 Aug 6;20(1):729. doi: 10.1186/s13018-025-06055-w.

MeSH Terms

Conditions

Pain, PostoperativeAgnosia

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
Participants will be randomly divided into two groups. The physician who will collect data in the orthopedic department will not know which group the participant is in.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 30, 2024

First Posted

February 4, 2025

Study Start

March 15, 2023

Primary Completion

December 15, 2024

Study Completion

December 15, 2024

Last Updated

June 5, 2025

Record last verified: 2025-05

Locations