Postoperative Quality of Recovery After Combined Lumbar Plexus-Sciatic Nerve Block (LPB-SNB)

Udayana University

Status and phase: Completed; Phase 3

Conditions: Lower Extremity Surgery

Treatments: Drug: USG Guided Combined LPB-SNB with Isobaric Bupivacaine; Drug: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT06301503

0103/UN14.2.2.VII.14/LT/2024

Details and patient eligibility

About

The goal of this clinical trial is to evaluate the efficacy of lumbar plexus-sciatic nerve block (LPB-SNB) by comparing the postoperative quality of recovery as assessed by the Quality of Recovery-40 (QoR-40) questionnaire, in patients who received a combination of LPB-SNB versus patients who received the traditional intravenous opioid, after lower extremity orthopaedic surgeries with spinal anaesthesia.

The main questions it aims to answer are:

• Will there be a significant difference in QoR-40 scores between both groups?
• Will the combined LPB-SNB significantly reduces opioid consumption within the first 24 hours?
• Will the combined LPB-SNB significantly increases postoperative duration of analgesia?

Participants will:

• Receive a coded sealed opaque envelope containing their randomly allocated intervention group; first group receives a combination of lumbar plexus-sciatic nerve block, while the second group receives no block at all. This information would not be disclosed to the participants.
• Receive an explanation on how to use the patient controlled analgesia (PCA) to deliver intravenous opioid, and instructions on filling in the QoR-40 questionnaire.

Researchers will then compare the results between both groups to see if the combined lumbar plexus-sciatic nerve block successfully provides adequate analgesia and enhance postoperative quality of recovery after lower extremity orthopaedic surgeries.

Full description

Following lower extremity orthopaedic surgeries, acute postoperative pain management plays a crucial on each patient's quality of recovery. Postoperative pain are usually classified as nociceptive, neuropathic, mixed, psychogenic, or idiopathic and so, a single treatment might be insufficient to treat it adequately. Multimodal analgesia, encompassing techniques such as the neuraxial blockade, peripheral nerve blocks, infiltration, patient-controlled opioid analgesia, and nonsteroidal anti-inflammatory drugs (NSAIDS), has been extensively investigated with aims to relieve postoperative pain.

Lumbar Plexus Block (LPB) and Sciatic Nerve Block (SNB) are peripheral nerve block techniques consisting of the two large nerve branches that innervate the lower leg area. The combination of these two blocks (LPB-SNB), guided by ultrasonography (USG), blocks pain sensation throughout the lower extremity, and has been studied as an effective multimodal analgesia technique to relieve postoperative pain. This technique can minimize postoperative pain and also reduce the amount of opioid consumption, thereby reducing the incidence of postoperative nausea and vomiting (PONV).

Patients' opinions of their medical care are the subject of an expanding array of assessment instruments being developed to gauge the level of postoperative recovery. The QoR-40 questionnaire is gaining popularity due to considerable validation of its utility in measuring quality of recovery. This questionnaire is appropriate for its intended use, responsive to changes in the therapeutic setting, and can yield reliable findings. The QoR-40 is a useful tool for assessing the anaesthesia and postoperative recovery quality in patients undergoing peripheral nerve blocks as well as in ordinary clinical practice. Nonetheless, there is currently limited research using the QoR-40 questionnaire to assess the quality of recovery in studies evaluating the efficacy of peripheral nerve blocks.

This randomised controlled, double-blind and single-center trial will be conducted in a tertiary care hospital with aims of evaluating the efficacy of combined LPB-SNB compared to the traditional intravenous opioid in providing adequate analgesia after lower extremity orthopaedic surgeries with spinal anaesthesia with its primary outcome being the patient's postoperative quality of recovery as assessed by the QoR-40 questionnaire.

Enrollment: 100 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients undergoing lower extremity orthopaedic surgery with spinal anaesthesia
• Patients aged between 18-65 years
• Patients with American Society of Anesthesiologists (ASA) physical status classification of I-III
• Patients with a body mass index (BMI) between 18-30 kg/m2

Exclusion criteria

• Patients with a history of allergy towards the local anaesthetic agents used
• Patients with contraindication to regional anaesthesia based on the American Society for Regional Anesthesia guidelines
• Patients with pre-existing mental or psychological disorders

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

1. USG Guided Combined LPB-SNB with Isobaric Bupivacaine

Experimental group

Description:

After completing the surgical procedure under spinal anaesthesia, participants are positioned in the lateral decubitus position with the side to be blocked facing upwards. Identification of the lumbar plexus nerves is carried out with ultrasound guidance using the trident approach. Under aseptic conditions, local anesthetic infiltration with 2% lidocaine (3ml)was given, and a lumbar plexus block (LPB) technique was performed by inserting a 100mm insulated nerve block needle through the transverse process, delivering a bolus of 0.25% isobaric bupivacaine (20ml). Without changing the participant's position, the sciatic nerve is identified by the gluteal approach. After local anesthetic infiltration with 2% lidocaine (3ml), sciatic nerve block (SNB) was performed by inserting a 100 mm insulated nerve block needle to the sciatic nerve, delivering a bolus of 0.25% isobaric bupivacaine (20ml). Aspiration is carried out before injecting anaesthetic agent on each puncture sites.

Treatment:

Drug: USG Guided Combined LPB-SNB with Isobaric Bupivacaine

2. Control

Active Comparator group

Description:

Postoperatively, participants in this group was positioned in the lateral decubitus position and both the lumbar plexus and sciatic nerves were identified using ultrasound. Local anesthetic infiltration was given at both puncture sites, but participants of this group did not receive a combination of LPB-SNB with bupivacaine.

Treatment:

Drug: Control