Postoperative PainNCT06522620
Effect of Posterior Femoral Cutaneous Nerve Block on Postoperative Posterior Lateral Knee Analgesia in Patients With TKA
A study testing Posterior Femoral Cutaneous Nerve Combined With Proximal Sciatic and Saphenous Nerve Block and Simple Sciatic and Saphenous Nerve Blocks in people with Postoperative Pain, run by General Hospital of Ningxia Medical University at 1 site in China.
Trial summary
The aim of this study was to observe the effects of posterior femoral cutaneous nerve block combined with sciatic and saphenous nerve block compared with sciatic and saphenous nerve block alone on postoperative posterior side of the knee (popliteal fossa) pain and sleep quality in patients with TKA, and to further… Read more about this study
- Who is it for?
- Ages 45 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Posterior Femoral Cutaneous Nerve Combined With Proximal Sciatic and Saphenous Nerve Block and Simple Sciatic and Saphenous Nerve Blocks
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2024to 25 Sep 2024
- Phase
- Interventional
- 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 45 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who are >45 years of age; intended to undergo elective first TKA under general anesthesia
- ASA grade II-III.
- Agreed to participate in this study and signed the informed consent form.
- BMI less than 28Kg/m2.
Who cannot join
- Patients who refuse to participate in the trial
- Preoperative inability to communicate due to speech and hearing impairment, etc.
- History of allergy to local anesthetics or opioids
- Contraindications to nerve block operation.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
General hospital of Ningxia medical university
Yinchuan, Ningxia, 750004
xinli Ni, MD, 86-0951-6743252, xinlini6@nyfy.com.cn
About this study
Official title: Posterior Femoral Cutaneous Nerve Combined With Proximal Sciatic and Saphenous Nerve Block for Postoperative Posterior Lateral Knee Analgesia in Patients With TKA: a Single-center, Prospective, Randomized Controlled Study
The aim of this study was to observe the effects of posterior femoral cutaneous nerve block combined with sciatic and saphenous nerve block compared with sciatic and saphenous nerve block alone on postoperative posterior side of the knee (popliteal fossa) pain and sleep quality in patients with TKA, and to further alleviate postoperative posterior side of the knee pain in patients with TKA and improve the quality of postoperative sleep.
Read the detailed description
Total knee arthroplasty (TKA) is one of the most common surgical procedures worldwide. Although surgical and anesthesia techniques have become more mature, poor postoperative pain control after TKA is still an important problem for patients and clinicians. Peripheral nerve blocks (PNBs) have been widely used in clinical practice for postoperative analgesia after TKA.The combinations of PNBs available for postoperative analgesia after TKA include femoral/obturator , femoral/sciatic/obturator, lumbar plexus/sciatic, and femoral/sciatic, and the combination of PNBs has been shown to be effective for postoperative analgesia after TKA in a study of TKA. Meta-analysis of postoperative pain management modalities, it was concluded that blocking multiple nerves was superior to blocking any of the nerves, periarticular infiltration, or epidural analgesia, while the combination of femoral and sciatic nerve block was overall the best postoperative analgesia for TKA. The investigators found that even in patients who underwent a single combined sciatic nerve and saphenous nerve block + continuous femoral nerve block, poor quality of sleep and pain in the affected limb were still common in the postoperative period, and the complaints of pain in the affected limb were mainly centered on the posterior side of the knee (popliteal fossa) and the margins. The area where the patient's complaints were concentrated was within the range of superficial skin sensation innervated by the posterior femoral cutaneous nerve, which is a pure sensory nerve that originates from the lumbosacral plexus, descends through the lower border of the pectineus muscle, and sends out three branches, among which the posterior femoral cutaneous branch innervates superficial sensation in the posterior thigh and popliteal fossa, and the innervation of the posterior femoral cutaneous nerve is not only limited to the posterior thigh and popliteal fossa, but may also extend to the ankle joint. even extend to the ankle joint. The investigators hypothesized that a posterior femoral cutaneous nerve block could reduce pain in the posterior side of the knee in patients after TKA, and there is a theoretically feasible anatomical basis for this hypothesis. Pain is one of the most important factors affecting the quality of sleep in patients, and pain relief may potentially improve the quality and prolong the duration of sleep in patients, thus providing the conditions for comfortable medical treatment and a good prognosis.
- Conditions
- Postoperative Pain
- Being tested
- Posterior Femoral Cutaneous Nerve Combined With Proximal Sciatic and Saphenous Nerve Block, Simple Sciatic and Saphenous Nerve Blocks
- Keywords
- Posterior Femoral Cutaneous Nerve, Nerve Block, TKA, posterior lateral knee pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterior Femoral Cutaneous Nerve Combined With Proximal Sciatic and Saphenous Nerve BlockProcedure or surgery
Also called supragluteal approach sciatic nerve block
All nerve blocks were performed under ultrasound guidance，single supragluteal approach sciatic nerve block using a nerve stimulator, 20 ml of drug was injected around the sciatic nerve, the extent of drug diffusion was observed, the needle tip was turned into the deep surface of the gluteus maximus muscle below the deep gluteal artery and 5 ml of drug was injected, followed by a retractile canal saphenous nerve block injected with 15 ml of drug, and the difference in sensation of the posterior thighs of the bilateral thighs was measured after 15 min to ensure posterior femoral cutaneous nerve were blocked
Simple Sciatic and Saphenous Nerve BlocksProcedure or surgery
Also called subgluteal approach sciatic nerve block
All nerve blocks were performed under ultrasound guidance，single subgluteal approach sciatic nerve block using a nerve stimulator, with 25 ml of drug injected around the sciatic nerve, followed by a retractile canal saphenous nerve block with 15 ml of drug injection
| Study group | Role | What they receive |
|---|---|---|
| Sciatic saphenous nerve block group (Group S) | Active comparator | Postoperative analgesia using subgluteal approach sciatic nerve block + saphenous nerve block Receives: Procedure: Simple Sciatic and Saphenous Nerve Blocks |
| Combined posterior femoral cutaneous nerve block group (Group P) | Experimental | Postoperative analgesia using supragluteal approach sciatic nerve block + posterior femoral cutaneous nerve block + saphenous nerve block Receives: Procedure: Posterior Femoral Cutaneous Nerve Combined With Proximal Sciatic and Saphenous Nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative anteroposterior and posterior knee Visual Analogue Scale scores (passive motion/resting)
The level of pain at the knee surface incision and on the posterior side of the knee at rest and motion was asked and recorded using the Visual Analogue Scale scores at postoperative hour 1 (before the patient left the PACU), postoperative hour 6, postoperative hour 24, and postoperative hour 48, respectively (0 for no pain and 10 for the most severe pain imaginable)
Measured: postoperative hour 1，postoperative hour 6，postoperative hour 24，postoperative hour 48
Secondary outcomes (6)
Postoperative night sleep time
Use of exercise bracelets to record actual hours of patient sleep
Measured: First night after surgery, second night after surgery
Earliest time on the ground
Length of time between the end of surgery and the patient's active movement off the floor
Measured: Within 48 hours of surgery
Amount of remedial opioid use
Total remedially applied opioids within 48 hours of surgery
Measured: Within 48 hours of surgery
Number of patient PCNA uses
Number of times a patient presses the PCNA in the 48 hours postoperatively
Measured: Within 48 hours of surgery
Incidence rate of postoperative adverse outcomes
Including （1）the number of people who experienced soreness in the affected limb, （2）the number of people who had nausea and the number of times they vomited,（3） the number of people who had the femoral nerve recanalized, （4）the number of people who had thrombosis in the first 48 hours after the operation, （5）and the number of people who had urinary retention.
Measured: Within 48 hours of surgery
Hip Knee Ankle
Comparison of the change in HKA angle on lower extremity X-ray film in patients during the preoperative week versus the change in HKA angle on lower extremity X-ray film during the postoperative week
Measured: within the preoperative week versus the postoperative week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start1 Jul 2024
- Primary completion25 Sep 2024 (estimated)
- Study completion25 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital of Ningxia Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06522620
- Sponsor's protocol ID
- Peng Liu-2024-1
- Status last verified
- Jul 2024
- First submitted
- 16 Jul 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Posterior Femoral Cutaneous Nerve Combined With Proximal Sciatic and Saphenous Nerve Block for Postoperative Posterior Lateral Knee Analgesia in Patients With TKA: a Single-center, Prospective, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06522620
- Acronym / sponsor ID
- Peng Liu-2024-1
- Conditions
- Postoperative Pain
- Keywords
- Posterior Femoral Cutaneous Nerve, Nerve Block, TKA, posterior lateral knee pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- General Hospital of Ningxia Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 25 Sep 2024 (estimated)
- Study completion
- 25 Sep 2024 (estimated)
- First posted
- 26 Jul 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 aim of this study was to observe the effects of posterior femoral cutaneous nerve block combined with sciatic and saphenous nerve block compared with sciatic and saphenous nerve block alone on postoperative posterior side of the knee (popliteal fossa) pain and sleep quality in patients with TKA, and to further alleviate postoperative posterior side of the knee pain in patients with TKA and improve the quality of postoperative sleep.
Detailed description
Total knee arthroplasty (TKA) is one of the most common surgical procedures worldwide. Although surgical and anesthesia techniques have become more mature, poor postoperative pain control after TKA is still an important problem for patients and clinicians. Peripheral nerve blocks (PNBs) have been widely used in clinical practice for postoperative analgesia after TKA.The combinations of PNBs available for postoperative analgesia after TKA include femoral/obturator , femoral/sciatic/obturator, lumbar plexus/sciatic, and femoral/sciatic, and the combination of PNBs has been shown to be effective for postoperative analgesia after TKA in a study of TKA. Meta-analysis of postoperative pain management modalities, it was concluded that blocking multiple nerves was superior to blocking any of the nerves, periarticular infiltration, or epidural analgesia, while the combination of femoral and sciatic nerve block was overall the best postoperative analgesia for TKA. The investigators found that even in patients who underwent a single combined sciatic nerve and saphenous nerve block + continuous femoral nerve block, poor quality of sleep and pain in the affected limb were still common in the postoperative period, and the complaints of pain in the affected limb were mainly centered on the posterior side of the knee (popliteal fossa) and the margins. The area where the patient's complaints were concentrated was within the range of superficial skin sensation innervated by the posterior femoral cutaneous nerve, which is a pure sensory nerve that originates from the lumbosacral plexus, descends through the lower border of the pectineus muscle, and sends out three branches, among which the posterior femoral cutaneous branch innervates superficial sensation in the posterior thigh and popliteal fossa, and the innervation of the posterior femoral cutaneous nerve is not only limited to the posterior thigh and popliteal fossa, but may also extend to the ankle joint. even extend to the ankle joint. The investigators hypothesized that a posterior femoral cutaneous nerve block could reduce pain in the posterior side of the knee in patients after TKA, and there is a theoretically feasible anatomical basis for this hypothesis. Pain is one of the most important factors affecting the quality of sleep in patients, and pain relief may potentially improve the quality and prolong the duration of sleep in patients, thus providing the conditions for comfortable medical treatment and a good prognosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sciatic saphenous nerve block group (Group S) | Active comparator | Procedure: Simple Sciatic and Saphenous Nerve BlocksPostoperative analgesia using subgluteal approach sciatic nerve block + saphenous nerve block |
| Combined posterior femoral cutaneous nerve block group (Group P) | Experimental | Procedure: Posterior Femoral Cutaneous Nerve Combined With Proximal Sciatic and Saphenous Nerve BlockPostoperative analgesia using supragluteal approach sciatic nerve block + posterior femoral cutaneous nerve block + saphenous nerve block |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who are >45 years of age; intended to undergo elective first TKA under general anesthesia
- ASA grade II-III.
- Agreed to participate in this study and signed the informed consent form.
- BMI less than 28Kg/m2.
Key exclusion criteria (4 listed)
- Patients who refuse to participate in the trial
- Preoperative inability to communicate due to speech and hearing impairment, etc.
- History of allergy to local anesthetics or opioids
- Contraindications to nerve block operation.
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 |
|---|---|---|
| Posterior Femoral Cutaneous Nerve Combined With Proximal Sciatic and Saphenous Nerve BlockAlso: supragluteal approach sciatic nerve blockAll nerve blocks were performed under ultrasound guidance，single supragluteal approach sciatic nerve block using a nerve stimulator, 20 ml of drug was injected around the sciatic nerve, the extent of drug diffusion was observed, the needle tip was turned into the deep surface of the gluteus maximus muscle below the deep gluteal artery and 5 ml of drug was injected, followed by a retractile canal saphenous nerve block injected with 15 ml of drug, and the difference in sensation of the posterior thighs of the bilateral thighs was measured after 15 min to ensure posterior femoral cutaneous nerve were blocked | Procedure or surgery | Combined posterior femoral cutaneous nerve block group (Group P) |
| Simple Sciatic and Saphenous Nerve BlocksAlso: subgluteal approach sciatic nerve blockAll nerve blocks were performed under ultrasound guidance，single subgluteal approach sciatic nerve block using a nerve stimulator, with 25 ml of drug injected around the sciatic nerve, followed by a retractile canal saphenous nerve block with 15 ml of drug injection | Procedure or surgery | Sciatic saphenous nerve block group (Group S) |
Primary outcome
Postoperative anteroposterior and posterior knee Visual Analogue Scale scores (passive motion/resting)
Time frame: postoperative hour 1，postoperative hour 6，postoperative hour 24，postoperative hour 48
The level of pain at the knee surface incision and on the posterior side of the knee at rest and motion was asked and recorded using the Visual Analogue Scale scores at postoperative hour 1 (before the patient left the PACU), postoperative hour 6, postoperative hour 24, and postoperative hour 48, respectively (0 for no pain and 10 for the most severe pain imaginable)
6 secondary outcomes
Postoperative night sleep time
Time frame: First night after surgery, second night after surgery
Earliest time on the ground
Time frame: Within 48 hours of surgery
Amount of remedial opioid use
Time frame: Within 48 hours of surgery
Number of patient PCNA uses
Time frame: Within 48 hours of surgery
Incidence rate of postoperative adverse outcomes
Time frame: Within 48 hours of surgery
Hip Knee Ankle
Time frame: within the preoperative week versus the postoperative week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Postoperative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Posterior Femoral Cutaneous Nerve Combined With Proximal Sciatic and Saphenous Nerve Block and Simple Sciatic and Saphenous Nerve Blocks in people with Postoperative Pain, run by General Hospital of Ningxia Medical University at 1 site in China.
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 4 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: status not confirmed, as of the sponsor's last update on 19 Sep 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 China. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xinli Ni, MD (13909586966, xinlini6@nyfy.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative anteroposterior and posterior knee Visual Analogue Scale scores (passive motion/resting) (time frame: postoperative hour 1，postoperative hour 6，postoperative hour 24，postoperative hour 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2024.