AzTrials
AzTrials

Pain, PostoperativeNCT04020133

the Role of Popliteal Plexus Block in Pain Management After Anterior Cruciate Ligament Reconstruction.

A study testing saphenous nerve block, popliteal plexus block and Plain bupivacaine in people with Pain, Postoperative, run by Fayoum University Hospital at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Anterior cruciate ligament (ACL) injury is traumatic and debilitating and is typically repaired using an arthroscopic technique performed as an outpatient surgical procedure. However, many patients complain that the postoperative pain is severe for the first 48 hours following the ACL reconstruction . Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pain, Postoperative
What is being tested?
saphenous nerve block, popliteal plexus block and Plain bupivacaine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
1 siteEgypt
Study dates
5 Sep 2019to Jan 2022
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • American Society of Anesthesiologist (ASA) physical status I/II/III .
  • Age > 18 years.
  • Body mass index of <40 kg/m2 .

Who cannot join

  • Patient refusal,
  • Un-cooperative patients
  • BMI>40kg/m2 .
  • Allergy to local anaesthetics.
  • Anticoagulation or bleeding disorders.
  • Pre-existing peripheral neuropathies.
  • Inflammation or infection over injection site.
  • Daily morphine consumption > 40 mg.

Trial locations and contacts

1 site in 1 country.

Mohamed O Sadewi, master contact

1092895804 ext. +20

mom01@fayoum.edu.eg

Egypt1 site, 1 recruiting
  • Fayoum university hospital

    Al Fayyum, 63514

    Hany M Yassin, MD, 1111363602 ext. +20, Hmyoo@fayoum.edu.eg

    Recruiting

Other trials in Egypt

About this study

Official title: Analgesic Effect of Adding Popliteal Plexus Block to Standard Saphenous Nerve Block in Patients Scheduled for Elective Arthroscopic Anterior Cruciate Ligament Reconstruction : Randomized Observer Blind Clinical Trial

Anterior cruciate ligament (ACL) injury is traumatic and debilitating and is typically repaired using an arthroscopic technique performed as an outpatient surgical procedure. However, many patients complain that the postoperative pain is severe for the first 48 hours following the ACL reconstruction .

Effective postoperative pain management is a critical component to recovery, effective rehabilitation and patient satisfaction. Following ACL reconstruction, psychological factors are predictive of outcomes, and pain levels are inversely associated with function and quality of life assessment.

Read more

ACL reconstruction procedures may reflect the complexity innervation of the anatomical areas involved, which includes the femoral nerve and its infrapatellar and saphenous branches, the obturator nerve, as well as the tibial and common peroneal branches of the sciatic nerve. Therefore, surgical variables, namely the location of surgical ports and the source of grafts used, and this creates challenge to anaesthesiologist to determine easy , safe and efficacious nerve block to be used in this setting .

A recently described popliteal plexus block(PPB) is claimed to anesthetize articular branches from the posterior obturator nerve and tibial nerve. It was recently confirmed in a cadaver study that injection of 10 mL of dye into the distal end of the adductor canal spreads via the adductor hiatus to the popliteal fossa and stains the popliteal plexus (PP).

A blockade of the popliteal plexus , has been claimed to produce an equivalent analgesic effect to sciatic nerve block after total knee arthroplasty without causing any motor weakness.

The current study hypothesize that combined saphenous nerve block with popliteal plexus block will enhance post operative analgesia after ACL reconstruction with motor sparing of thigh and leg muscles. Thus, faster recovery and earlier post-operative physiotherapy.

The objective of the current study is to evaluate analgesic effect of combined saphenous and popliteal plexus block as post -operative analgesia for anterior cruciate ligament reconstruction operation compared to standard saphenous nerve block .

Patients scheduled for ACL reconstruction will be randomly assigned into one of two groups: the intervention group will receive popliteal plexus block and saphenous nerve block and the control group will receive the standard saphenous nerve block only.

Read the detailed description

This study will be performed in Fayoum university Hospital from january 2019 to january 2021 on 58 adult patients undergoing ACL operation after obtaining approval of the Scientific and Ethical Committee of El Fayoum University Hospitals, and written informed consent from the patients.

Randomization will be done by using computer-generated random numbers that will be placed in separate opaque envelopes that will be opened by study investigators just before the block. Neither the participants, the study investigators, the attending clinicians, nor the data collectors will be aware of groups' allocation until the study end. The Consolidated Standards of Reporting Trials (CONSORT) recommendations for reporting randomized, controlled clinical trials will be followed.

Preoperative preparation:

History taking , physical examination and investigations will be done according to the local protocol designed to evaluate the patients. which includes complete blood count, blood sugar level, serum urea and creatinine ,liver function tests,coagulation profile and electrocardiogram (ECG) Before surgery, the participants will receive education about the VAS pain score (0-100 mm) (where0=no pain and 100 = worst comprehendible pain)and the details of the nerve block procedures. After a 6 h fast, the patients will be taken into the operation theatre.

Intraoperative management :

The patient will receive Midazolam 0.03 mg/kg intravenous (IV) and Cefotaxime 1 gm as premedication . Monitors (pulse oximeter, electrocardiography and non invasive blood pressure ) will be applied.

Induction of general anaesthesia will be done via propofol 1-2 mg/kg , fentanyl 1-3 mic/kg and atracurium 0.5 mg/kg . Endotracheal tube will be inserted and the patient will be mechanically ventilated. Anesthesia will be maintained with oxygen and isoflurane 1-2 % or as required and atracurium 10mg every 30 minutes. Fentanyl boluses 0.5 μg/kg will be repeated if heart rate (HR) or mean arterial pressure (MAP) rise 20 % above baseline values . Ondansetron 4 mg IV dose will be administered for postoperative nausea and vomiting (PONV) prophylaxis 30 min before the end of the case; dexamethasone use will be avoided due to its potential confounding effect on the block characteristics.and then , nerve blocks will be given according to randomization.

The skin is disinfected and the saphenous nerve is located via Ultrasound . the transducer is placed anteromedially, approximately at mid-thigh level "a high-frequency linear probe 5Y12 megahertz (MHz) prepared in a sterile fashion" (Phillips HD11) . If the artery is not immediately obvious, several maneuvers can be used to identify it, including color Doppler scanning to trace the femoral artery caudally from the inguinal crease. Once the femoral artery has been identified, the probe is moved distally to trace the artery until it passes through the adductor hiatus to become the popliteal artery.

The block needle (Stimuplex; Braun Medical, Bethlehem, Pa), is inserted in plane in a lateral-to-medial orientation and advanced toward the femoral artery . the passage of the needle through the sartorius and/or adductor muscles and into the adductor canal is usually associated with a paresthesia in the saphenous nerve distribution. Once the needle tip is visualized anterior to the artery and after careful aspiration, 1-2 mL of local anesthetic is injected to confirm the proper injection site . When injection of local anesthetic does not appear to result in its spread around the femoral artery, additional needle repositions and injections may be necessary.

Then , moving distally with the artery in the adductor canal until it moves away from the sartorius muscle to enter adductor hiatus . here , L.A will be injected above the artery and so , popliteal plexus block will be accomplished .

Both blocks done via in injection 15 mg bupivacaine 0.5% + 0.05 mg epinephrine. After the block done , VAS score , BP , HR , cumulative and interval opioid consumption and sedation level via Ramsay sedation scale will be measured every 4 hours for 24 hours post-operatively .

Rescue analgesia in the form of morphine per a titration protocol (3 mg morphine sulfate IV as a bolus dose that could be repeated every 5 minutes with a maximum dose of 15mg per 4 hours or 45 mg per 24 hours) was employed if visual analog pain scale (VAS) > 4. The morphine titration protocol was suspended with Oxygen saturation < 95%; Respiratory rate < 10 / min; the development of sedation (Ramsay sedation scale >2); development of acute adverse effects (allergy, marked itching, excessive vomiting, and hypotension with systolic blood pressure _ 20% of baseline values); or attaining adequate level of analgesia.

Statistical Analysis:

Sample size was calculated using (G power version 3). Minimal sample size of patients was 26 in each group needed to get power level 0.80, alpha level 0.05 and 0.8 as an effect size in the time for painkiller request after the intervention between the two groups. To overcome problem of loss of follow up, calculated sample size was increased by 10% to reach 29 in each group.

Being tested
saphenous nerve block, popliteal plexus block, Plain bupivacaine, 0.05 mg epinephrine
Keywords
ACL, popliteal plexus block, saphenous nerve block
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • saphenous nerve blockProcedure or surgery

    Also called adductor canal block

    The skin is disinfected and the saphenous nerve is located via Ultrasound . the transducer is placed anteromedially, approximately at mid-thigh level "a high-frequency linear probe 5Y12 MHz prepared in a sterile fashion" (Phillips HD11) .

    The block needle (Stimuplex; Braun Medical, Bethlehem, Pa), is inserted in plane in a lateral-to-medial orientation and advanced toward the femoral artery .Once the needle tip is visualized anterior to the artery and after careful aspiration, 1-2 mL of local anesthetic is injected to confirm the proper injection site . When injection of local anesthetic does not appear to result in its spread around the femoral artery, additional needle repositions and injections may be necessary.

  • popliteal plexus blockProcedure or surgery

    After doing saphenous nerve block , we will move distally with the artery in the adductor canal until it moves away from the sartorius muscle to enter adductor hiatus . here , we will inject L.A above artery and so , popliteal plexus block will be accomplished

  • Plain bupivacaineDrug

    15ml of plain bupivacaine 0.5% will be given in both blocks

  • 0.05 mg epinephrineDrug

    0.05 mg epinephrine will be added to bupivacaine in both blocks to prolong their duration

Study groups in NCT04020133
Study groupRoleWhat they receive
the control groupActive comparatorthis group will receive post-operative saphenous nerve block by 1mg/kg plain bupivacaine 0.5% plus epinephrine 0.05 mg.
Receives: Procedure: saphenous nerve block; Drug: Plain bupivacaine; Drug: 0.05 mg epinephrine
the intervention groupActive comparatorthis group will receive popliteal plexus block by 1mg/kg plain bupivacaine 0.5% plus epinephrine 0.05 mg in addition to standard saphenous nerve block by 1mg/kg plain bupivacaine 0.5% plus epinephrine 0.05 mg.
Receives: Procedure: saphenous nerve block; Procedure: popliteal plexus block; Drug: Plain bupivacaine; Drug: 0.05 mg epinephrine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The duration of analgesia

    the pain will be assisted based on the time needed for the first dose rescue analgesia

    Measured: 24 hours post-operative

Secondary outcomes (30)
  1. the cumulative opioid consumption

    the total amount of opioid received post operative

    Measured: 24 hours post operative

  2. The intervals between opioid (morphine) doses

    the time needed between two successive opioid doses

    Measured: 24 hours post-operative

  3. the quality of analgesia based on visual analogue scale (VAS) pain scores at rest

    Severity of pain estimated by visual analog score (VAS) (where 0 = no pain, and 100 = worst imaginable pain)

    Measured: 4 hours post-operative

  4. the quality of analgesia based on visual analogue scale (VAS) pain scores at rest

    Severity of pain estimated by visual analog score (VAS) (where 0 = no pain, and 100 = worst imaginable pain)

    Measured: 8 hours post-operativE

  5. the quality of analgesia based on visual analogue scale (VAS) pain scores at rest

    Severity of pain estimated by visual analog score (VAS) (where 0 = no pain, and 100 = worst imaginable pain)

    Measured: 12 hours post-operative

  6. the quality of analgesia based on visual analogue scale (VAS) pain scores at rest

    Severity of pain estimated by visual analog score (VAS) (where 0 = no pain, and 100 = worst imaginable pain)

    Measured: 16 hours post-operative

  7. the quality of analgesia based on visual analogue scale (VAS) pain scores at rest

    Severity of pain estimated by visual analog score (VAS) (where 0 = no pain, and 100 = worst imaginable pain)

    Measured: 20 hours post-operative

  8. the quality of analgesia based on visual analogue scale (VAS) pain scores at rest

    Severity of pain estimated by visual analog score (VAS) (where 0 = no pain, and 100 = worst imaginable pain)

    Measured: 24 hours post-operative

  9. Incidence of complications related to both techniques

    complications related to the Block or drug administered

    Measured: 24 hours post-operatively

  10. Incidence of nausea

    Morphine related side effect

    Measured: 4 hours post-operative

  11. Incidence of nausea

    Morphine related side effect

    Measured: 8 hours post-operative

  12. Incidence of nausea

    Morphine related side effect

    Measured: 12 hours post-operative

  13. Incidence of nausea

    Morphine related side effect

    Measured: 24 hours post-operative

  14. Incidence of vomiting

    Morphine related side effect

    Measured: 4 hours post-operative

  15. Incidence of vomiting

    Morphine related side effect

    Measured: 8 hours post-operative

  16. Incidence of vomiting

    Morphine related side effect

    Measured: 12 hours post-operative

  17. Incidence of vomiting

    Morphine related side effect

    Measured: 24 hours post-operative

  18. Incidence of pruritus

    Morphine related side effect

    Measured: 4 hours post-operative

  19. Incidence of pruritus

    Morphine related side effect

    Measured: 8 hours post-operative

  20. Incidence of pruritus

    Morphine related side effect

    Measured: 12 hours post-operative

  21. Incidence of pruritus

    Morphine related side effect

    Measured: 24 hours post-operative

  22. Rate of over-sedation

    Morphine related side effect

    Measured: 4 hours post-operative

  23. Rate of over-sedation

    Morphine related side effect

    Measured: 8 hours post-operative

  24. Rate of over-sedation

    Morphine related side effect

    Measured: 12 hours post-operative

  25. Rate of over-sedation

    Morphine related side effect

    Measured: 24 hours post-operative

  26. Incidence of urine retension

    Morphine related side effect

    Measured: 4 hours post-operative

  27. Incidence of urine retension

    Morphine related side effect

    Measured: 8 hours post-operative

  28. Incidence of urine retension

    Morphine related side effect

    Measured: 12 hours post-operative

  29. Incidence of urine retension

    Morphine related side effect

    Measured: 24 hours post-operative

  30. Patients satisfaction with postoperative analgesia

    Will be evaluated according to a satisfaction score (poor = 0; fair = 1; good = 2; excellent= 3)

    Measured: 24 hours post-operative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2019
  2. Study start5 Sep 2019
  3. Primary completionOct 2021 (estimated)
  4. Study completionJan 2022 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
58 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04020133
Sponsor's protocol ID
D182
Status last verified
Nov 2020
First submitted
20 Jan 2019
Last updated
9 Nov 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Runge C, Moriggl B, Borglum J, Bendtsen TF. The Spread of Ultrasound-Guided Injectate From the Adductor Canal to the Genicular Branch of the Posterior Obturator Nerve and the Popliteal Plexus: A Cadaveric Study. Reg Anesth Pain Med. 2017 Nov/Dec;42(6):725-730. doi: 10.1097/AAP.0000000000000675.

    PubMed 28937534
  • Runge C, Bjorn S, Jensen JM, Nielsen ND, Vase M, Holm C, Bendtsen TF. The analgesic effect of a popliteal plexus blockade after total knee arthroplasty: A feasibility study. Acta Anaesthesiol Scand. 2018 Sep;62(8):1127-1132. doi: 10.1111/aas.13145. Epub 2018 May 24.

    PubMed 29797704
  • Sehmbi H, Brull R, Shah UJ, El-Boghdadly K, Nguyen D, Joshi GP, Abdallah FW. Evidence Basis for Regional Anesthesia in Ambulatory Arthroscopic Knee Surgery and Anterior Cruciate Ligament Reconstruction: Part II: Adductor Canal Nerve Block-A Systematic Review and Meta-analysis. Anesth Analg. 2019 Feb;128(2):223-238. doi: 10.1213/ANE.0000000000002570.

    PubMed 29064877
  • Manickam B, Perlas A, Duggan E, Brull R, Chan VW, Ramlogan R. Feasibility and efficacy of ultrasound-guided block of the saphenous nerve in the adductor canal. Reg Anesth Pain Med. 2009 Nov-Dec;34(6):578-80. doi: 10.1097/aap.0b013e3181bfbf84.

    PubMed 19916251
  • Mahmoud A, Boules M, Botros J, Mostafa M, Ragab S, Alsaeid M. Analgesic Impact of a Popliteal Plexus Block to Standard Adductor Canal Block in Arthroscopic Anterior Cruciate Ligament Reconstruction: A Randomized Blind Clinical Trial. Pain Res Manag. 2021 Dec 17;2021:1723471. doi: 10.1155/2021/1723471. eCollection 2021.

    PubMed 34956430

Questions about this trial

What is this clinical trial studying?

A study testing saphenous nerve block, popliteal plexus block and Plain bupivacaine in people with Pain, Postoperative, run by Fayoum University Hospital at 1 site in Egypt.

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 3 inclusion and 8 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 9 Nov 2020. 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 Egypt. 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 Mohamed O Sadewi, master (1092895804 ext. +20, mom01@fayoum.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The duration of analgesia (time frame: 24 hours post-operative). 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 NCT04020133, which also lists 5 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 9 Nov 2020.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in