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临床试验/NCT06888349
NCT06888349已完成不适用

The Effect of Combined IPACK(Interspace Between the Popliteal Artery and the Capsule of the Posterior Knee) Block with Adductor Canal Block Versus Adductor Canal Block Alone on Pain Management and Early Mobility After Total Knee Arthroplasty

Ain Shams University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年1月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
The first time to need analgesic rescue .

研究概览

简要总结

This trial was established to assess efficiency of IPACK block in combination with ACB in relieving postoperative pain , particularly posterior knee pain and providing early rehabilitation after TKA in comparison with ACB alone .

详细描述

This trial was established to assess efficiency of IPACK block in combination with ACB in relieving postoperative pain , particularly posterior knee pain and providing early rehabilitation after TKA in comparison with ACB alone .All patients were subjected to full history taking including current medications and thorough physical examination.

Age, sex, BMI and ASA physical status were recorded and Preoperative investigations were done to all patients including laboratory investigations as (complete blood picture, bleeding time, prothrombin time and activated partial thromboplastin time) and other investigations according to the patient's medical condition. The patients were fasting for 2 to 8 hours preoperatively. All patients were consented with a written consent for the spinal anesthesia and either of the peripheral regional blocks that were held after explaining the procedure. Intraoperatively, All patients were monitored by pulse oximeter, non-invasive blood pressure cuff and electrocardiogram for heart rate and rhythm. IV Access was applied. All patients received 0.03 mg/kg midazolam iv, granisetron 1mg iv and dexamethasone 10 mg iv as a prophylaxis against nausea and vomiting.Sign IN and Time OUT checklist were revised before starting the anesthetic procedure and the surgical procedure, respectively.All patients received spinal anesthesia using 15 mg 0.5% hyperbaric bupivacaine in the sitting position at L3-4 or L4-5 intervertebral space.All patients received Intraoperative fluids and sedation with intravenous dexmedetomidine if needed.Checking on the availability of intralipid (lipid emulsion 20%) nearby and preparation of the ultrasound device (investigators used in the recent study the Sonosite M-Turbo C Portable Ultrasound). After patients' stabilization, Patients were divided into 2 group.

Group A: received ultrasound guided adductor canal block (ACB) alone using 22 Gag spinal needle with injection of 15ml 0.25% bupivacaine with addition of 2mg dexamethasone and 2.5mcg /ml epinephrine as an adjuvant to prolong its action.

Group B: received ultrasound guided adductor canal block (ACB) as group A, in addition to ultrasound guided infiltration of the interspace between popliteal artery and the capsule of posterior knee (IPACK) block with either of the two previously mentioned approaches, using 22Gag spinal needle injecting 20ml 0.25%bupivacaine with addition of 2mg dexamethasone and 2.5mcg /ml epinephrine as an adjuvant to prolong its action. Postoperatively,All patients were transferred to the post anesthesia care unit (PACU).

All patients were monitored at (PACU) for oxygen saturation, heart rate and blood pressure for 2hours observational period.The two groups of patients were evaluated and compared as regard:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

盲法说明

Arm1: received ultrasound guided adductor canal block (ACB) alone . Arm2:received ultrasound guided adductor canal block (ACB) as group A, in addition to ultrasound guided infiltration of the interspace between popliteal artery and the capsule of posterior knee (IPACK) block

入排标准

年龄范围
45 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Sex: Patients of either sex
  • •Age: between 45 and 75 years.
  • •Physical status: ASA I- III.
  • •Weight: BMI between 28-40 kg/m
  • •Lesion: any patient with knee pathology requiring total knee arthroplasty (TKA)

排除标准

  • •o Body mass index >40 kg/m
  • •ASA>III.
  • •Patient's refusal.
  • •Revision knee arthroplasty
  • •Bilateral knee arthroplasty.
  • •Lack of mental ability to provide informed consent.
  • •Neuropathic pain or sensory disorders of the surgical limb.
  • •Contraindication to regional anesthesia (intolerance to the study drugs, bleeding diathesis, coagulopathy, malignancy or infection at the site of block).

研究组 & 干预措施

adductor canal block (ACB) alone

Active Comparator

received ultrasound guided adductor canal block (ACB) alone using 22 Gag spinal needle with injection of 15ml 0.25% bupivacaine with addition of 2mg dexamethasone and 2.5mcg /ml epinephrine as an adjuvant to prolong its action.

干预措施: spinal anesthesia (Procedure)

adductor canal block (ACB) alone

Active Comparator

received ultrasound guided adductor canal block (ACB) alone using 22 Gag spinal needle with injection of 15ml 0.25% bupivacaine with addition of 2mg dexamethasone and 2.5mcg /ml epinephrine as an adjuvant to prolong its action.

干预措施: Adductor Canal Block (Procedure)

adductor canal block (ACB)in addition to (IPACK) block

Active Comparator

received ultrasound guided adductor canal block (ACB) as group A, in addition to ultrasound guided infiltration of the interspace between popliteal artery and the capsule of posterior knee (IPACK) block with either of the two previously mentioned approaches, using 22Gag spinal needle injecting 20ml 0.25%bupivacaine with addition of 2mg dexamethasone and 2.5mcg /ml epinephrine as an adjuvant to prolong its action.

干预措施: spinal anesthesia (Procedure)

adductor canal block (ACB)in addition to (IPACK) block

Active Comparator

received ultrasound guided adductor canal block (ACB) as group A, in addition to ultrasound guided infiltration of the interspace between popliteal artery and the capsule of posterior knee (IPACK) block with either of the two previously mentioned approaches, using 22Gag spinal needle injecting 20ml 0.25%bupivacaine with addition of 2mg dexamethasone and 2.5mcg /ml epinephrine as an adjuvant to prolong its action.

干预措施: Adductor Canal Block (Procedure)

adductor canal block (ACB)in addition to (IPACK) block

Active Comparator

received ultrasound guided adductor canal block (ACB) as group A, in addition to ultrasound guided infiltration of the interspace between popliteal artery and the capsule of posterior knee (IPACK) block with either of the two previously mentioned approaches, using 22Gag spinal needle injecting 20ml 0.25%bupivacaine with addition of 2mg dexamethasone and 2.5mcg /ml epinephrine as an adjuvant to prolong its action.

干预措施: interspace between Popliteal artery and capsule of knee (IPACK) block (Procedure)

结局指标

主要结局

The first time to need analgesic rescue .

时间窗: 2days

The first time to need analgesic rescue when (Numerical rating scale score ≥ 4 which means moderate to severe pain ) is recorded in hours (the Numerical rating scale consist of a series of numbers rating pain intensity, typically from 0 to 10 with 0 being "no pain" 1to3 being "mild pain,4to6 being "moderate pain "and 7to10 being "sever pain" . So that the higher the number the worse is the pain.

postoperative pain degree

时间窗: 48hours

two groups of patients were evaluated and compared as regard the Degree of postoperative pain using Numerical Rating Scale (NRS) which consist of a series of numbers rating pain intensity, typically from 0 to 10 with 0 being "no pain" and 10 being "the worst pain imaginable.", So that the higher the number the worse is the pain . The numerical rating scale is recorded each 4hours at the first 48 hours.

the total amount of analgesic rescues needed measured in numbers

时间窗: 2days

Number of analgesic rescues needed when patient's pain is moderate to sever

次要结局

  • Age(At the time of patients' enrollment in the study.)
  • Mobility recovery(2days)
  • Degree of motor recovery(2days)
  • Fast recovery and early hospital discharge(48hours)
  • Sex influence on degree of pain(At the time of patients' enrollment in the study.)
  • BMI(kg/m2)(At the time of patients'enrollment in the study.)
  • Motor recovery(2days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Esraa Alaa El Deen Mahmoud Abass

Esraa Alaa(Assistant lecturer at anesthesia,ICU and pain department of faculty of medicine/ Ain shams university

Ain Shams University

研究点 (1)

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