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
试验速览
- 阶段
- 不适用
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- The duration of analgesia
研究概览
简要总结
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.
详细描述
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 :
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologist (ASA) physical status I/II/III .
- •Age > 18 years.
- •Body mass index of <40 kg/m2 .
排除标准
- •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.
研究组 & 干预措施
the control group
this group will receive post-operative saphenous nerve block by 1mg/kg plain bupivacaine 0.5% plus epinephrine 0.05 mg.
干预措施: saphenous nerve block (Procedure)
the control group
this group will receive post-operative saphenous nerve block by 1mg/kg plain bupivacaine 0.5% plus epinephrine 0.05 mg.
干预措施: Plain bupivacaine (Drug)
the control group
this group will receive post-operative saphenous nerve block by 1mg/kg plain bupivacaine 0.5% plus epinephrine 0.05 mg.
干预措施: 0.05 mg epinephrine (Drug)
the intervention group
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.
干预措施: saphenous nerve block (Procedure)
the intervention group
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.
干预措施: popliteal plexus block (Procedure)
the intervention group
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.
干预措施: Plain bupivacaine (Drug)
the intervention group
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.
干预措施: 0.05 mg epinephrine (Drug)
结局指标
主要结局
The duration of analgesia
时间窗: 24 hours post-operative
the pain will be assisted based on the time needed for the first dose rescue analgesia
次要结局
- Incidence of complications related to both techniques(24 hours post-operatively)
- Incidence of vomiting(24 hours post-operative)
- Incidence of pruritus(24 hours post-operative)
- Rate of over-sedation(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(24 hours post-operative)
- Incidence of nausea(24 hours post-operative)
- Patients satisfaction with postoperative analgesia(24 hours post-operative)
- the cumulative opioid consumption(24 hours post operative)
- Incidence of urine retension(24 hours post-operative)
研究者
Hany M Yassin, MD
Associate professor of Anesthesiology
Fayoum University Hospital