Fascia Iliaca Compartment Block and Tramadol for Analgesia in Hip Fracture

Comparison of Perioperative Analgesic Effects of Preoperative Supra-inguinal Fascia Iliaca Compartment Block and Intravenous Tramadol in Hip Fracture: A Randomized Controlled Trial

Hip fractures are a growing public health concern globally due to the aging population, with high incidence and significant mortality rates one year post-fracture. Effective pain management is critical to improving outcomes and accelerating recovery. Tramadol, a widely used intravenous analgesic, has dual opioid and non-opioid mechanisms but is associated with side effects, such as nausea, dizziness, and respiratory depression, necessitating careful monitoring in hip fracture patients.

The supra-inguinal fascia iliaca compartment block (SiFICB) offers a promising alternative, targeting key nerves to achieve effective analgesia through ultrasound-guided delivery of local anesthetics. SiFICB minimizes side effects and improves pain control by accurately blocking the femoral, lateral femoral cutaneous, and obturator nerves. While its postoperative benefits are well-documented, its efficacy in managing preoperative pain from hip fractures remains underexplored.

This study hypothesizes that ultrasound-guided SiFICB provides superior perioperative analgesia compared to intravenous tramadol. A prospective randomized controlled trial will evaluate the analgesic efficacy of SiFICB, using the numerical rating scale (NRS) to assess pain, aiming to improve the management of hip fracture-related pain and patient outcomes.

Study Overview

• Status: Not yet recruiting
• Conditions: Hip Fractures; Perioperative Analgesia; Ultrasound-guided Nerve Block
• Intervention / Treatment: Other: supra-inguinal fascia iliaca compartment block; Drug: Tramadol

Detailed Description

Background With the global aging population, the incidence of hip fractures continues to rise. In the United States, over 300,000 cases occur annually among individuals aged 65 years or older. The incidence of hip fractures in Europe ranges between 307 and 1269 per 100,000 population. Mortality rates one year after a hip fracture are alarmingly high, ranging from 19.7% to 34.8%, making hip fractures a significant public health issue. It is estimated that the global number of hip fracture cases will increase to 2.6-7.3 million by 2025 and 4.5-21.3 million by 2050 . Optimizing treatment pathways for hip fractures, promoting accelerated postoperative recovery, and improving patient outcomes are therefore critical.

Early pain management intervention can alleviate pain, reduce anxiety, improve sleep, and significantly decrease complications and mortality associated with hip fractures . Currently, intravenous tramadol is a commonly used analgesic. Tramadol, a synthetic opioid, acts as a μ-opioid receptor agonist with weak affinity and inhibits serotonin (5-HT) and norepinephrine (NE) reuptake, exerting dual analgesic effects . It is increasingly replacing high-affinity opioids for the treatment of moderate-to-severe acute and chronic pain globally. However, tramadol has adverse effects, including sweating, dizziness, nausea, vomiting, appetite loss, urinary retention, and risks of addiction, misuse, and respiratory depression. Its use in hip fracture patients requires close monitoring to manage adverse effects promptly.

The pain associated with hip fractures arises from noxious stimulation of free nerve endings transmitting nociceptive and proprioceptive signals. The nerves innervating the hip skin originate from the lumbar plexus, including the femoral nerve and lateral femoral cutaneous nerve. The anterior hip joint capsule receives sensory input from the femoral and obturator nerves. Pain receptors in the anterior capsule are most densely distributed in the superior portion, while they are sparse in the posterior capsule and ligaments surrounding the hip joint.

Based on this anatomical understanding, a Supra-inguinal fascia iliaca compartment block (SiFICB) above the inguinal ligament can effectively block the femoral and lateral femoral cutaneous nerves. The spread of local anesthetics medially in the fascia iliaca compartment can also block the obturator nerve, achieving analgesia. However, fascia iliaca blocks can have adverse effects, including inadequate localization leading to poor efficacy, quadriceps weakness due to femoral nerve blockade, and local anesthetic toxicity. Ultrasound guidance can ensure accurate delivery of local anesthetics into the fascia iliaca compartment, allowing for lower concentrations and reduced adverse effects. Although studies have reported the efficacy of ultrasound-guided fascia iliaca blocks for postoperative pain relief after hip surgeries , their impact on preoperative pain caused by fracture displacement or friction of fracture ends remains underexplored.

The investigators hypothesize that an ultrasound-guided SiFICB above the inguinal ligament provides superior perioperative analgesia compared with intravenous tramadol, the current standard of care in orthopedic trauma. To test this hypothesis, the investigators design a prospective randomized controlled trial in patients undergoing hip fracture surgery, using the numerical rating scale (NRS) as the primary outcome to assess pain, to evaluate the perioperative analgesic efficacy of ultrasound-guided SiFICB by comparison to intravenous tramadol in patients with hip fractures.

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ren Liao, M.D.; Phone Number: +86-18980602177; Email: liaoren7733@163.com

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital, Sichuan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with a confirmed diagnosis of hip fracture
• Aged >18 years, of any gender
• Provide signed and dated written informed consent before formal enrollment in the study.

Exclusion Criteria:

• Allergic to tramadol or ropivacaine
• Unable to cooperate with the study for any reason, such as language comprehension issues, psychiatric disorders, severe hearing impairments, or communication barriers
• Unsuitable for the trial by the investigator based on clinical judgment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SiFICB Group; Participants will receive an ultrasound-guided SiFICB above the inguinal ligament with 40 ml of 0.25% ropivacaine.	Other: supra-inguinal fascia iliaca compartment block; Supra-inguinal fascia iliaca compartment block with 40 ml of 0.25% ropivacaine
Active Comparator: Tramadol Group; Participants will receive intravenous tramadol at a dose of 2 mg/kg	Drug: Tramadol; intravenous tramadol at a dose of 2 mg/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resting numerical rating scale (NRS) pain scores preoperatively	The Numerical Rating Scale (NRS) is a tool for assessing pain intensity, allowing patients to rate their pain on a scale from 0 to 10, where 0 represents "no pain," 10 represents "the worst pain imaginable," and pain levels are categorized as 0 (no pain), 1-3 (mild pain), 4-6 (moderate pain), and 7-10 (severe pain).	7 days postperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of severe complications	Mortality and the overall incidence of severe complications are classified into five grades: Grade I (fully resolved with temporary treatment, e.g., postoperative nausea and vomiting), Grade II (prolonged hospital stay required, e.g., pneumonia requiring antibiotic treatment), Grade III (life-threatening events requiring intervention with recovery during hospitalization, e.g., deep vein thrombosis), Grade IV (significant long-term harm, e.g., postoperative cognitive dysfunction), and Grade V (death within 30 days postoperatively).	7 days postperatively
Resting NRS pain scores postoperatively	Resting NRS pain scores on postoperative days 1, 2, and 3	3 days after surgery
Movement NRS pain scores postoperatively	Movement NRS pain scores on postoperative days 1, 2, and 3	3 days after surgery
Total perioperative morphine consumption	Morphine is used as a rescue measure for acute pain. When a patient's resting NRS pain score exceeds 4, 5 mg of morphine can be administered intravenously. If the effect is insufficient, an additional 5 mg may be given after 30 minutes, with a maximum daily dose of 20 mg.	7 days postperatively
Time to initiation of functional exercise	Duration from admission to the first mobilization, pre- or postoperatively (days)	30 days postperatively
Total length of hospital stay	Duration from admission to discharge (days)	30 days postperatively
Postoperative hospital stay	Duration from surgery to discharge (days)	30 days postperatively
Total hospitalization costs	Total hospitalization costs	7 days after discharge

Collaborators and Investigators

• Sponsor: West China Hospital
• Investigators: Principal Investigator: Ren Liao, M.D., West China Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: December 1, 2024
• First Submitted That Met QC Criteria: December 6, 2024
• First Posted (Estimated): December 11, 2024

Study Record Updates

• Last Update Posted (Estimated): December 11, 2024
• Last Update Submitted That Met QC Criteria: December 6, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Tramadol; Hip Fractures; Supra-inguinal Fascia Iliaca compartment Block
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures; Physiological Effects of Drugs; Peripheral Nervous System Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics; Analgesics, Opioid; Narcotics; Tramadol
• Other Study ID Numbers: WCH20241201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Individual participant data (IPD) will be shared after de-identification.The shared data will include de-identified individual participant data, and metadata supporting the primary and secondary outcomes, as well as the study protocol.Data will be available beginning 6 months after publication of the main study results and ending 3 years following publication.

Requests for data sharing should be directed to the corresponding author (liaoren7733@163.com). Upon approval of a formal proposal, a data-sharing agreement will be signed, and access will be granted through a secure data-sharing platform.

• IPD Sharing Time Frame: Data will be available beginning 6 months after publication of the main study results and ending 3 years following publication.
• IPD Sharing Access Criteria: Requests for data sharing should be directed to the corresponding author (liaoren7733@163.com).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No