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

NCT06301503 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-05-03

No results posted yet for this study

Summary

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.

Conditions

  • Lower Extremity Surgery

Interventions

DRUG

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)

DRUG

Control

Local anesthetic infiltration of 2% lidocaine (3ml)

Sponsors & Collaborators

  • Udayana University

    lead OTHER

Principal Investigators

  • Jeremia A Wiranata, MD · Udayana University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-09
Primary Completion
2024-05-01
Completion
2024-05-02

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06301503 on ClinicalTrials.gov