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

NCT04020133 | Unknown

• 1 other identifier: D182
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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 . 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. 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.

Conditions

Pain, Postoperative

Keywords

ACL; popliteal plexus block; saphenous nerve block

Outcome Measures

Primary Outcomes (1)

• The duration of analgesia

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

  24 hours post-operative

Secondary Outcomes (30)

• the cumulative opioid consumption

  24 hours post operative

• The intervals between opioid (morphine) doses

  24 hours post-operative

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

  4 hours post-operative

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

  8 hours post-operativE

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

  12 hours post-operative

Study Arms (2)

the control group

ACTIVE COMPARATOR

this group will receive post-operative saphenous nerve block by 1mg/kg plain bupivacaine 0.5% plus epinephrine 0.05 mg.

Procedure: saphenous nerve block; Drug: Plain bupivacaine; Drug: 0.05 mg epinephrine

the intervention group

ACTIVE COMPARATOR

this 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.

Procedure: saphenous nerve block; Procedure: popliteal plexus block; Drug: Plain bupivacaine; Drug: 0.05 mg epinephrine

Interventions

saphenous nerve block PROCEDURE

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.

Also known as: adductor canal block

the control group; the intervention group

popliteal plexus block PROCEDURE

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

the intervention group

Plain bupivacaine DRUG

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

the control group; the intervention group

0.05 mg epinephrine DRUG

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

the control group; the intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fayoum University Hospital: lead

Study Sites (1)

Fayoum university hospital

Al Fayyum, 63514, Egypt

RECRUITING

Related Publications (5)

• 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.

  PMID: 28937534 BACKGROUND

• 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.

  PMID: 29797704 BACKGROUND

• 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.

  PMID: 29064877 BACKGROUND

• 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.

  PMID: 19916251 BACKGROUND

• 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.

  PMID: 34956430 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Epinephrine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Hany MO Yassin, MD

  faculty of medicine , fayoum university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed O Sadewi, master

CONTACT

1092895804; mom01@fayoum.edu.eg

Atef M Sayed, MD

CONTACT

1003973883; amk04@fayoum.edu.rg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of Anesthesiology

Study Record Dates

• First Submitted: January 20, 2019
• First Posted: July 15, 2019
• Study Start: September 5, 2019
• Primary Completion: October 1, 2021
• Study Completion: January 1, 2022
• Last Updated: November 9, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)