The Efficacy of Erector Spinae Plane Block Compared to Intrathecal Morphine for Postoperative Analgesia in Lumbar Spine Surgery Patients: A DOUBLE - BLINDED RETROSPECTIVE COMPARATIVE STUDY.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- VAS score
研究概览
简要总结
The study design will be double blinded retrospective controlled comparative study.
The patients will be included in the study shoud be in the following category:
- American Society of Anesthesiologists (ASA) physical status I, II
- Age range from 18 and 70 years.
The patients will be discarded from the study shoud be in the following:
- patient refusal.
- significant renal, hepatic and cardiovascular diseases.
- Pregnancy.
- Any contraindication to regional anesthesia such as local infection or bleeding disorders.
- Chronic opioid use, history of chronic pain and cognitive disorders.
- Lumbar spine lesion revision and dural tear. Postoperative pain will be evaluated using a visual analogue scale (VAS) score as primary outcome measure.
demographic data ( Age, Weight, sex and height) , ASA classification ,mean operative times (min), time to the first rescue analgesic (min) ,intraoperative fentanyl consumption(microgram),postoperative opioid consumption ,sedation score, hemodynamics intraoperative and postoperative ( BP ,H R and oxgen saturation %) and complications as 2ry outcome measures.
详细描述
This study will be performed in the in the FAYOUM University hospital after the local Institutional Ethics Committee and local institutional review board approval. The study design will be double blinded retrospective controlled comparative study. A detailed informed consent will be signed by the eligible patients before recruitment and randomization.
Inclusion criteria:
- American Society of Anesthesiologists (ASA) physical status I, II patients who will be scheduled for elective lumbar surgery for one or two levels.
- Age range from 18 and 70 years.
Exclusion criteria:
- patient refusal.
- significant renal, hepatic and cardiovascular diseases.
- History of allergy to one of the study drugs.
- Pregnancy.
- Any contraindication to regional anesthesia such as local infection or bleeding disorders.
- Chronic opioid use, history of chronic pain and cognitive disorders.
- Lumbar spine lesion revision and dural tear. Randomization will be done via computer-generated random numbers that will be placed in separate closed envelopes and will be opened by study investigators just after induction of general anesthesia. Neither the patients, the study investigators, the attending clinicians nor the data collectors will be aware of the allocation of groups till the study ends.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Randomization will be done via computer-generated random numbers that will be placed in separate closed envelopes and will be opened by study investigators just after induction of general anesthesia. Neither the patients, the study investigators, the attending clinicians nor the data collectors will be aware of the allocation of groups till the study ends.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •American Society of Anesthesiologists (ASA) physical status I, II patients who will be scheduled for elective lumbar surgery for one or two levels. • Age range from 18 and 70 years.
排除标准
- •patient refusal.
- •significant renal, hepatic and cardiovascular diseases.
- •History of allergy to one of the study drugs.
- •Pregnancy.
- •Any contraindication to regional anesthesia such as local infection or bleeding disorders.
- •Chronic opioid use, history of chronic pain and cognitive disorders.
- •Lumbar spine lesion revision and dural tear.
研究组 & 干预措施
Group ( ultrasound guided erectae spinae block)
The same anesthesiologist who is experienced in US guided regional anesthesia will perform the block. In the group ESP, a high frequency linear US probe (HFL_50, 15_6MHz) will be placed vertically and nearly 3 cm lateral to the vertebra in the middle of the incision line. The transverse process and the overlaying erector spinae muscles (ESM) will be identified under parasagittal scanning A22 G,50 mm block needle (SONOTAP,Pajunk, Geisingen,Germany) will be inserted at a 30-40° angle in the cranial to caudal direction via an in-plane approach and advanced into the plane between the fascia of ESM and transverse process under sterile conditions. The correct needle position will be confirmed after a hydro dissection with 3 ml of isotonic saline, and then 20 ml of 0.25% bupivacaine will be injected in the interfascial plane between the rhomboideus major muscle and ESM. The local anesthetic spread will be visualized in a fascial longitudinal pattern deep to the ESM.
干预措施: Ultrasound guided lumbar erectae spinae block (Other)
Group (Intrathecal morphine)
In the group of intrathecal morphine , a lumbar puncture will be done in the lateral position via a midline approach into the level of the vertebra which exists in the middle of the incision with complete aseptic condition using 25 gauge Quincke spinal needle to give 0.3 mg of morphine (preservative free form) suspended in 0.4 ml of normal saline .
干预措施: Ultrasound guided lumbar erectae spinae block (Other)
Group (Intrathecal morphine)
In the group of intrathecal morphine , a lumbar puncture will be done in the lateral position via a midline approach into the level of the vertebra which exists in the middle of the incision with complete aseptic condition using 25 gauge Quincke spinal needle to give 0.3 mg of morphine (preservative free form) suspended in 0.4 ml of normal saline .
干预措施: Intrathecal Morphine injection (Other)
Group ( ultrasound guided erectae spinae block)
The same anesthesiologist who is experienced in US guided regional anesthesia will perform the block. In the group ESP, a high frequency linear US probe (HFL_50, 15_6MHz) will be placed vertically and nearly 3 cm lateral to the vertebra in the middle of the incision line. The transverse process and the overlaying erector spinae muscles (ESM) will be identified under parasagittal scanning A22 G,50 mm block needle (SONOTAP,Pajunk, Geisingen,Germany) will be inserted at a 30-40° angle in the cranial to caudal direction via an in-plane approach and advanced into the plane between the fascia of ESM and transverse process under sterile conditions. The correct needle position will be confirmed after a hydro dissection with 3 ml of isotonic saline, and then 20 ml of 0.25% bupivacaine will be injected in the interfascial plane between the rhomboideus major muscle and ESM. The local anesthetic spread will be visualized in a fascial longitudinal pattern deep to the ESM.
干预措施: Intrathecal Morphine injection (Other)
结局指标
主要结局
VAS score
时间窗: Every 4 bours for 48 hours post operative
The mean VAS score (score 0 =no pain and 10 =worst pain ever ) in the two groups of the study.
次要结局
- Hemodynamics post-operative(Every 4 hours for 24 hours)
- Age(Day 1)
- Gender(Day 1)
- Body Mass Index(Day 1)
- Intra and post-operative opoid injected(up to 48 hours)
- Complications(up to 48 hours)
- Height(Day 1)
- Weight(Day 1)
- Time for 1ST analgesic request(up to 48 hours)
- Ramsy sedation score(Every 4 hours for 24 hours)
- Mean operative time(during surgery)
- Hemodynamics intra operative(Every half hour during surgery)
研究者
Atef Mohamed Sayed mahmoud
Principal investigator
Fayoum University Hospital