protocolSection identificationModule nctId: NCT06301503, orgStudyIdInfo id: 0103/UN14.2.2.VII.14/LT/2024, briefTitle: Postoperative Quality of Recovery After Combined Lumbar Plexus-Sciatic Nerve Block (LPB-SNB), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-08, primaryCompletionDateStruct date: 2024-04-20, completionDateStruct date: 2024-04-25, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Udayana University, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Lower Extremity Surgery, designModule 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: SINGLE, 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. Participants would be blinded to the group allocation., whoMasked: PARTICIPANT, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: USG Guided Combined LPB-SNB with Isobaric Bupivacaine, interventions name: Control, outcomesModule primaryOutcomes measure: Postoperative Quality of Recovery as assessed by the QoR-40 questionnaire, secondaryOutcomes measure: Postoperative Intravenous Opioid Consumption, secondaryOutcomes measure: Postoperative Analgesia Duration, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Prof. Dr. I.G.N.G. Ngoerah General Hospital, status: RECRUITING, city: Denpasar, state: Bali, zip: 80114, country: Indonesia, contacts name: Tjokorda GA Senapathi, Professor, role: CONTACT, phone: +6281337711220, email: tjoksenapathi@unud.ac.id, contacts name: Tjokorda GA Senapathi, Professor, role: SUB_INVESTIGATOR, contacts name: Pontisomaya Parami, Consultant, role: SUB_INVESTIGATOR, contacts name: Made Wiryana, Professor, role: SUB_INVESTIGATOR, contacts name: I Made G Widnyana, Doctorate, role: SUB_INVESTIGATOR, contacts name: I Putu P Suarjaya, Doctorate, role: SUB_INVESTIGATOR, contacts name: I Gusti NM Aribawa, Doctorate, role: SUB_INVESTIGATOR, contacts name: Ida Bagus KJ Sutawan, Consultant, role: SUB_INVESTIGATOR, contacts name: Georgina M Tiberias, MD, role: SUB_INVESTIGATOR, geoPoint lat: -8.65, lon: 115.21667, hasResults: False