Multimodal Analgesia Versus Peripheral Nerve Block for Postoperative Pain Management After Lower Limb Injury Surgery

NCT06779968 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 2024-MER-317
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical trial is to understand the effectiveness of femoral nerve block, combined sciatic and femoral nerve block, lumbar plexus block, epidural block, and intravenous analgesia pump in the application of lower limb injury (total knee replacement, knee arthroscopy, patella fracture, femoral shaft fracture) surgery. It will also understand the safety of the drugs liposomal bupivacaine and ropivacaine. The main question it aims to answer is: Does nerve block reduce the number of times participants need to use analgesics postoperatively? The researchers will compare femoral nerve block, combined sciatic and femoral nerve block, lumbar plexus block, epidural block, and intravenous analgesia pump to see which analgesic method has the best postoperative analgesic effect. Participants will: undergo nerve block first, then endotracheal intubation general anesthesia after entering the operating room; record vital signs during surgery, record postoperative analgesic doses, NRS pain scores, patient satisfaction, and postoperative nausea and vomiting.

Conditions

Lower Limb Injury

Outcome Measures

Primary Outcomes (1)

• Numerical Rating Scale(NRS)

  The NRS, Numerical Rating Scale, is a rating system from 0 to 10, where 0 represents "no pain" and 10 represents the worst possible pain.

  At baseline (before therapy), at 2 hours post-treatment, at 6 hours post-treatment, at 12 hours post-treatment, and at 24 hours post-treatment

Secondary Outcomes (3)

• Postoperative Opioid Consumption

  Total consumption measured at 24 hours post-treatment and at 48 hours post-treatment.

• Postoperative Nausea and Vomiting (PONV)

  At 2 hours post-treatment, at 6 hours post-treatment, at 12 hours post-treatment and at 24 hours post-treatment.

• Patient Satisfaction

  At 48 hours post-treatment.

Study Arms (5)

FNB Group

EXPERIMENTAL

In the femoral nerve block (FNB) group, the femoral nerve was blocked distal to the inguinal ligament and lateral to the femoral artery. Under sterile conditions and ultrasound guidance using a short-axis out-of-plane approach, a 22-gauge insulated needle was advanced adjacent to the femoral nerve. Following confirmation of correct needle tip placement, a 20 mL volume of either 266 mg liposomal bupivacaine (diluted as indicated) or 0.2% ropivacaine was injected. This was followed by a continuous infusion at a rate of 5-10 mL/hr. For pediatric patients, a continuous infusion of 0.2% ropivacaine was administered at an initial bolus of 0.2-0.5 mg/kg, followed by a continuous infusion of 0.1-0.3 mg/kg/hr.

Device: Femoral Nerve Block; Device: General Aneasthesia

CS-FNB Group

EXPERIMENTAL

In the combined sciatic and femoral nerve block (CS-FNB) group, the femoral nerve block was performed as described above. The sciatic nerve block was performed at either the gluteal region or popliteal fossa. Under sterile conditions and ultrasound guidance using either an in-plane or out-of-plane approach, a 22-gauge insulated needle was advanced adjacent to the sciatic nerve. Following confirmation of correct needle tip placement, a 20 mL volume of either 266 mg liposomal bupivacaine (diluted as indicated) or 0.2% ropivacaine was injected. This was followed by a continuous infusion at a rate of 5-10 mL/hr. For pediatric patients, a continuous infusion of 0.2% ropivacaine was administered at an initial bolus of 0.2-0.5 mg/kg, followed by a continuous infusion of 0.1-0.3 mg/kg/hr.

Device: Combined Sciatic and Femoral Nerve Block; Device: General Aneasthesia

LPB Group

EXPERIMENTAL

In the lumbar plexus block (LPB) group, the lumbar plexus was blocked paraspinally within the psoas muscle. Under sterile conditions, ultrasound guidance, or with the assistance of a nerve stimulator, using either an in-plane or out-of-plane approach, a 22-gauge insulated needle was advanced within the psoas muscle adjacent to the lumbar plexus. Following confirmation of correct needle tip placement, a 20 mL volume of either 266 mg liposomal bupivacaine (diluted as indicated) or 0.2% ropivacaine was injected. This was followed by a continuous infusion at a rate of 5-10 mL/hr. For pediatric patients, a continuous infusion of 0.2% ropivacaine was administered at an initial bolus of 0.2-0.5 mg/kg, followed by a continuous infusion of 0.1-0.3 mg/kg/hr.

Device: Lumbar plexus block; Device: General Aneasthesia

EA group

ACTIVE COMPARATOR

For epidural analgesia, an initial bolus of 5-15 mL of 0.5% ropivacaine was administered followed by a continuous infusion of 0.2% ropivacaine at a rate of 3-10 mL/hr. For pediatric patients, an initial bolus of 0.2% ropivacaine at 0.5-1 mg/kg was administered, not exceeding a maximum total dose of 2-2.5 mg/kg, followed by a continuous infusion of 0.1-0.3 mg/kg/hr.

Procedure: Epidural Analgesia

PCA group

EXPERIMENTAL

For intravenous patient-controlled analgesia (PCA), fentanyl was administered at a dose of 2 mcg/kg, diluted in 100 mL of normal saline. The basal infusion rate was set at 2 mL/hr, with a PCA dose of 2 mL and a lockout interval of 15 minutes.

Drug: Intravenous patient-controlled analgesia; Device: General Aneasthesia

Interventions

Femoral Nerve Block DEVICE

In the femoral nerve block (FNB) group, the femoral nerve was blocked distal to the inguinal ligament and lateral to the femoral artery. Under sterile conditions and ultrasound guidance using a short-axis out-of-plane approach, a 22-gauge insulated needle was advanced adjacent to the femoral nerve. Following confirmation of correct needle tip placement, a 20 mL volume of either 266 mg liposomal bupivacaine (diluted as indicated) or 0.2% ropivacaine was injected. This was followed by a continuous infusion at a rate of 5-10 mL/hr. For pediatric patients, a continuous infusion of 0.2% ropivacaine was administered at an initial bolus of 0.2-0.5 mg/kg, followed by a continuous infusion of 0.1-0.3 mg/kg/hr.

FNB Group

Combined Sciatic and Femoral Nerve Block DEVICE

In the combined sciatic and femoral nerve block (CS-FNB) group, the femoral nerve block was performed as described above. The sciatic nerve block was performed at either the gluteal region or popliteal fossa. Under sterile conditions and ultrasound guidance using either an in-plane or out-of-plane approach, a 22-gauge insulated needle was advanced adjacent to the sciatic nerve. Following confirmation of correct needle tip placement, a 20 mL volume of either 266 mg liposomal bupivacaine (diluted as indicated) or 0.2% ropivacaine was injected. This was followed by a continuous infusion at a rate of 5-10 mL/hr. For pediatric patients, a continuous infusion of 0.2% ropivacaine was administered at an initial bolus of 0.2-0.5 mg/kg, followed by a continuous infusion of 0.1-0.3 mg/kg/hr.

CS-FNB Group

Lumbar plexus block DEVICE

In the lumbar plexus block (LPB) group, the lumbar plexus was blocked paraspinally within the psoas muscle. Under sterile conditions, ultrasound guidance, or with the assistance of a nerve stimulator, using either an in-plane or out-of-plane approach, a 22-gauge insulated needle was advanced within the psoas muscle adjacent to the lumbar plexus. Following confirmation of correct needle tip placement, a 20 mL volume of either 266 mg liposomal bupivacaine (diluted as indicated) or 0.2% ropivacaine was injected. This was followed by a continuous infusion at a rate of 5-10 mL/hr. For pediatric patients, a continuous infusion of 0.2% ropivacaine was administered at an initial bolus of 0.2-0.5 mg/kg, followed by a continuous infusion of 0.1-0.3 mg/kg/hr.

LPB Group

Epidural Analgesia PROCEDURE

For epidural analgesia, an initial bolus of 5-15 mL of 0.5% ropivacaine was administered followed by a continuous infusion of 0.2% ropivacaine at a rate of 3-10 mL/hr. For pediatric patients, an initial bolus of 0.2% ropivacaine at 0.5-1 mg/kg was administered, not exceeding a maximum total dose of 2-2.5 mg/kg, followed by a continuous infusion of 0.1-0.3 mg/kg/hr.

EA group

Intravenous patient-controlled analgesia DRUG

For intravenous patient-controlled analgesia (PCA), fentanyl was administered at a dose of 2 mcg/kg, diluted in 100 mL of normal saline. The basal infusion rate was set at 2 mL/hr, with a PCA dose of 2 mL and a lockout interval of 15 minutes.

PCA group

General Aneasthesia DEVICE

Following administration of the regional anesthesia, general anesthesia with endotracheal intubation will be performed. Anesthesia induction will be achieved using propofol (1.5-2 mg/kg i.v.), rocuronium (1-2 mg/kg i.v.), and fentanyl (1-2 μg/kg i.v.). Anesthesia will be maintained using sevoflurane or desflurane, with inhaled concentration adjusted based on Bispectral Index (BIS) monitoring. A continuous infusion of remifentanil (0.05-0.2 μg/kg/min) will be administered, with adjustments to maintain blood pressure and heart rate within ±20% of baseline values. Following induction, patients will be mechanically ventilated in pressure-regulated volume control (PRVC) mode. The ventilator (Aestiva; GE Healthcare, Waukesha, Wisconsin, USA) settings will be: tidal volume 6-8 mL/kg, positive end-expiratory pressure 0 cm H2O, inspiratory to expiratory ratio 1:2, respiratory rate 16 breaths per minute (BPM), and fraction of inspired oxygen 41%.

CS-FNB Group; FNB Group; LPB Group; PCA group

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists (ASA) physical status classification I-III
• Patients (or their guardians) voluntarily participate in this study and sign a written informed consent form
• Patients (or their guardians) are able to understand the study content and cooperate with the study protocol

You may not qualify if:

• Known allergy to local anesthetics or opioid analgesics.
• Presence of contraindications to local or epidural anesthesia.
• Presence of undiagnosed or poorly characterized neuropathic pain.
• Presence of severe mental illness that would impede the participant's ability to cooperate with study assessment and treatment procedures.
• Clinically significant coagulopathy or current use of anticoagulant medications.
• Presence of infection at the planned puncture site or systemic infection.
• Pregnancy or lactation.

Sponsors & Collaborators

• Xiaguang Duan: lead

Study Sites (1)

Inner Mongolia Baogang Hospital

Baotou, Inner Mongolia, 014010, China

Location

MeSH Terms

Conditions

Leg Injuries

Interventions

Analgesia, Epidural; Analgesia, Patient-Controlled

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia

Central Study Contacts

Xiaguang Duan, Master's degree

CONTACT

+86 13314720012; alonlord2023@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Chief of Anesthesiology

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: January 17, 2025
• Study Start: January 20, 2025
• Primary Completion: May 1, 2025
• Study Completion: May 10, 2025
• Last Updated: January 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: January 2026-January 2031
• Access Criteria: A proposal that describes planned analyses must be submitted or whether a data sharing agreement must be signed.

Locations

CN (1)