Postoperative Quality of Recovery After Combined Lumbar Plexus-Sciatic Nerve Block for Lower Extremity Orthopaedic Surgeries: A Double-Blind Randomised Controlled Trial

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

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.

2024-03-09

2024-05-01

2024-05-02

Completed

Early phase I

100

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': '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.', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 100, 'type': 'ACTUAL'}}

2024-05-03