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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-09

Study Completion Date

2024-05-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Difference in Occurrence of Rebound Pain in Patients Undergoing Surgery Under Popliteal Block or Ankle Block

NCT05734469

Anesthesia, Regional Anesthesia and Analgesia

UNKNOWN NA

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

NCT06779968

Lower Limb Injury

NOT_YET_RECRUITING NA

Comparison of Two Techniques of Sciatic Nerve Block With Levobupivacaine 0.5% in Orthopedic Surgery

NCT01734954

Anesthesia

UNKNOWN NA

Influence of Sensory Block Duration on Rebound Pain After Outpatient Foot Surgery Under Popliteal Sciatic Nerve Block.

NCT06309381

Rebound Pain Sciatic Nerve Block Foot Surgery +1 more

COMPLETED

Continuous Sciatic Nerve Block vs Epidural Analgesia in Lower Limb Amputation for Postoperative Pain

NCT05608733

Phantom Limb Pain Pain, Chronic

UNKNOWN PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lower Extremity Surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

One hundred participants are to be randomly assigned by a computer-generated random number table into two parallel groups and 1:1 allocation to either receive a combination of LPB-SNB or no block at all.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Numbers were prepared in sealed envelopes prepared by a third party not involved in the study to ensure allocation concealment, and handed over to the anesthetist performing the block before surgery. Both participants and outcome assessors would be blinded to the group allocation.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1. USG Guided Combined LPB-SNB with Isobaric Bupivacaine

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.

Group Type EXPERIMENTAL

USG Guided Combined LPB-SNB with Isobaric Bupivacaine

Intervention Type DRUG

Local anesthetic infiltration of 2% lidocaine (3ml) along with injection anaesthetic agent consisting of isobaric bupivacaine 0.25% (20 ml)

2. Control

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.

Group Type ACTIVE_COMPARATOR

Control

Intervention Type DRUG

Local anesthetic infiltration of 2% lidocaine (3ml)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

USG Guided Combined LPB-SNB with Isobaric Bupivacaine

Local anesthetic infiltration of 2% lidocaine (3ml) along with injection anaesthetic agent consisting of isobaric bupivacaine 0.25% (20 ml)

Intervention Type DRUG

Control

Local anesthetic infiltration of 2% lidocaine (3ml)

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

LPB SNB Lumbar Plexus Block Sciatic Nerve Block Psoas Compartment Block (PCB) PCB PCA-Only Non-Block

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes