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

NCT06301503 | Completed Phase 3 DMC

• 1 other identifier: 0103/UN14.2.2.VII.14/LT/2024
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Postoperative Quality of Recovery as assessed by the QoR-40 questionnaire

  The QoR-40 questionnaire is gaining popularity due to considerable validation of its utility in measuring quality of recovery. The QoR-40 questionnaire has 40 questions divided into 5 assessment dimensions, namely comfort (12 questions), emotions (9 questions), physical independence (5 questions), support (8 questions) and pain (6 questions), where each question has a value of 1 to 5 based on the Likert scale.

  24 hours postoperatively

Secondary Outcomes (2)

• Postoperative Intravenous Opioid Consumption

  24 hours postoperatively

• Postoperative Analgesia Duration

  Within 24 hours postoperatively

Study Arms (2)

1. USG Guided Combined LPB-SNB with Isobaric Bupivacaine

EXPERIMENTAL

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.

Drug: USG Guided Combined LPB-SNB with Isobaric Bupivacaine

2. Control

ACTIVE COMPARATOR

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.

Drug: Control

Interventions

USG Guided Combined LPB-SNB with Isobaric Bupivacaine DRUG

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

Also known as: LPB, SNB, Lumbar Plexus Block, Sciatic Nerve Block, Psoas Compartment Block (PCB), PCB

1. USG Guided Combined LPB-SNB with Isobaric Bupivacaine

Control DRUG

Local anesthetic infiltration of 2% lidocaine (3ml)

Also known as: PCA-Only, Non-Block

2. Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Udayana University: lead

Study Sites (1)

Prof. Dr. I.G.N.G. Ngoerah General Hospital

Denpasar, Bali, 80114, Indonesia

Location

Related Publications (4)

• Touray ST, de Leeuw MA, Zuurmond WW, Perez RS. Psoas compartment block for lower extremity surgery: a meta-analysis. Br J Anaesth. 2008 Dec;101(6):750-60. doi: 10.1093/bja/aen298. Epub 2008 Oct 22.

  PMID: 18945717 BACKGROUND

• Strid JMC, Sauter AR, Ullensvang K, Andersen MN, Daugaard M, Bendtsen MAF, Soballe K, Pedersen EM, Borglum J, Bendtsen TF. Ultrasound-guided lumbar plexus block in volunteers; a randomized controlled trial. Br J Anaesth. 2017 Mar 1;118(3):430-438. doi: 10.1093/bja/aew464.

  PMID: 28203808 BACKGROUND

• Horasanli E, Gamli M, Pala Y, Erol M, Sahin F, Dikmen B. A comparison of epidural anesthesia and lumbar plexus-sciatic nerve blocks for knee surgery. Clinics (Sao Paulo). 2010;65(1):29-34. doi: 10.1590/S1807-59322010000100006.

  PMID: 20126343 RESULT

• Aissa I, Wartiti LE, Bouhaba N, Khallikane S, Moutaoukil M, Kartite N, Elkoundi A, Benakrout A, Chlouchi A, Elbouti A, Najout H, Grine A, Touab R, Zaizi A, Youssef J, Bakkali H, Balkhi H, Bensghir M. [Combined lumbar plexus-sciatic nerve block in the emergency surgery for pertrochanteric fracture: an alternative technique in patients at high risk of anaesthetic complications]. Pan Afr Med J. 2020 Sep 3;37:12. doi: 10.11604/pamj.2020.37.12.21392. eCollection 2020. French.

  PMID: 33062115 RESULT

Study Officials

• Jeremia A Wiranata, MD

  Udayana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist Resident

Model Details: 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.

Study Record Dates

• First Submitted: March 2, 2024
• First Posted: March 8, 2024
• Study Start: March 9, 2024
• Primary Completion: May 1, 2024
• Study Completion: May 2, 2024
• Last Updated: May 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Beginning from 6 months and ending in 2 years after online article publication
• Access Criteria: Researchers who provide a methodologically sound proposal of related studies. Proposals should be directed to jeremiaalvian@student.unud.ac.id. To gain access, data requestors will need to sign a data access agreement.

Locations

ID (1)