Lower Extremity SurgeryPhase 3NCT06301503
Postoperative Quality of Recovery After Combined Lumbar Plexus-Sciatic Nerve Block (LPB-SNB)
A Phase 3 study testing USG Guided Combined LPB-SNB with Isobaric Bupivacaine in people with Lower Extremity Surgery, run by Udayana University at 1 site in Indonesia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Lower Extremity Surgery
- What is being tested?
- USG Guided Combined LPB-SNB with Isobaric Bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIndonesia
- Study dates
- 9 Mar 2024to 2 May 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Prof. Dr. I.G.N.G. Ngoerah General Hospital
Denpasar, Bali, 80114
About this study
Official title: Postoperative Quality of Recovery After Combined Lumbar Plexus-Sciatic Nerve Block for Lower Extremity Orthopaedic Surgeries: A Double-Blind Randomised Controlled Trial
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:
Read more
- 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.
Read the detailed description
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
- Lower Extremity Surgery
- Being tested
- USG Guided Combined LPB-SNB with Isobaric Bupivacaine, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
USG Guided Combined LPB-SNB with Isobaric BupivacaineDrug
Also called LPB, SNB, Lumbar Plexus Block, Sciatic Nerve Block
Local anesthetic infiltration of 2% lidocaine (3ml) along with injection anaesthetic agent consisting of isobaric bupivacaine 0.25% (20 ml)
ControlDrug
Also called PCA-Only, Non-Block
Local anesthetic infiltration of 2% lidocaine (3ml)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours postoperatively
Secondary outcomes (2)
Postoperative Intravenous Opioid Consumption
Total opioid consumption within 24 hours after lower extremity orthopaedic surgery (in milligrams).
Measured: 24 hours postoperatively
Postoperative Analgesia Duration
The duration of the postoperative analgesia, measured from the time the surgery was done (control group) or combined block was given (combined LPB-SNB group) till the time when participant first presses the PCA button in request of intravenous opioid (in minutes)
Measured: Within 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start9 Mar 2024
- Primary completion1 May 2024
- Study completion2 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lower Extremity SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Udayana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeremia Alvian Wiranata, Udayana University
- Investigators
- Jeremia A Wiranata, MD, Principal investigator, Udayana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06301503
- Sponsor's protocol ID
- 0103/UN14.2.2.VII.14/LT/2024
- Status last verified
- May 2024
- First submitted
- 2 Mar 2024
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Publications
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.
PubMed 18945717Strid 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.
PubMed 28203808Horasanli 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.
PubMed 20126343Aissa 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.
PubMed 33062115
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Quality of Recovery After Combined Lumbar Plexus-Sciatic Nerve Block for Lower Extremity Orthopaedic Surgeries: A Double-Blind Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06301503
- Acronym / sponsor ID
- 0103/UN14.2.2.VII.14/LT/2024
- Conditions
- Lower Extremity Surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Udayana UniversityUniversity, hospital or other
- Study start
- 9 Mar 2024 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 2 May 2024 (actual)
- First posted
- 8 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 1. USG Guided Combined LPB-SNB with Isobaric Bupivacaine | Experimental | Drug: USG Guided Combined LPB-SNB with Isobaric BupivacaineAfter 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. |
| 2. Control | Active comparator | Drug: ControlPostoperatively, 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| USG Guided Combined LPB-SNB with Isobaric BupivacaineAlso: LPB, SNB, Lumbar Plexus Block, Sciatic Nerve BlockLocal anesthetic infiltration of 2% lidocaine (3ml) along with injection anaesthetic agent consisting of isobaric bupivacaine 0.25% (20 ml) | Drug | 1. USG Guided Combined LPB-SNB with Isobaric Bupivacaine |
| ControlAlso: PCA-Only, Non-BlockLocal anesthetic infiltration of 2% lidocaine (3ml) | Drug | 2. Control |
Primary outcome
Postoperative Quality of Recovery as assessed by the QoR-40 questionnaire
Time frame: 24 hours postoperatively
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.
2 secondary outcomes
Postoperative Intravenous Opioid Consumption
Time frame: 24 hours postoperatively
Postoperative Analgesia Duration
Time frame: Within 24 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Background: PubMed 18945717Touray 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.
- Background: PubMed 28203808Strid 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.
- Results publication: PubMed 20126343Horasanli 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.
- Results publication: PubMed 33062115Aissa 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.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeremia A Wiranata, MD principal investigator
Udayana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing USG Guided Combined LPB-SNB with Isobaric Bupivacaine in people with Lower Extremity Surgery, run by Udayana University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Quality of Recovery as assessed by the QoR-40 questionnaire (time frame: 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06301503, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024.