Fascia Iliaca Compartment Block and Tramadol for Analgesia in Hip Fracture

NCT06728033 | Not Yet Recruiting

• 1 other identifier: WCH20241201
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hip Fractures; Ultrasound-guided Nerve Block; Perioperative Analgesia

Keywords

Hip Fractures; Supra-inguinal Fascia Iliaca compartment Block; Tramadol

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Incidence of severe complications

  7 days postperatively

• Resting NRS pain scores postoperatively

  3 days after surgery

• Movement NRS pain scores postoperatively

  3 days after surgery

• Total perioperative morphine consumption

  7 days postperatively

• Time to initiation of functional exercise

  30 days postperatively

Study Arms (2)

SiFICB Group

EXPERIMENTAL

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

Tramadol Group

ACTIVE COMPARATOR

Participants will receive intravenous tramadol at a dose of 2 mg/kg

Drug: Tramadol

Interventions

supra-inguinal fascia iliaca compartment block OTHER

Supra-inguinal fascia iliaca compartment block with 40 ml of 0.25% ropivacaine

SiFICB Group

Tramadol DRUG

intravenous tramadol at a dose of 2 mg/kg

Tramadol Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Hip Fractures

Interventions

Tramadol

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids

Study Officials

• Ren Liao, M.D.

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ren Liao, M.D.

CONTACT

+86-18980602177; liaoren7733@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: As the clinical management differs between groups, researchers, participants, and clinical staff will be aware of the group allocations; however, follow-up personnel, outcome assessors, and statisticians will remain blinded to group assignments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 1, 2024
• First Posted: December 11, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

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

Locations

CN (1)