Dexamethasone Versus Dexmedetomidine as Local Anesthetic Adjuvants in Ultrasound Guided Transversus Abdominis Plane Block for Total Abdominal Hysterectomies
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Time to first request of analgesia
研究概览
简要总结
The transversus abdominis plane (TAP) block is most often used to provide surgical anesthesia for minor, superficial procedures on the lower abdominal wall, or postoperative analgesia for procedures below the umbilicus providing anesthesia to the ipsilateral lower abdomen below the umbilicus.
In a recent meta-analysis, the TAP block was shown to reduce the need for postoperative opioid use, increase the time to the first request for further analgesia, and provide more effective pain relief, while decreasing opioid-related side effects such as sedation and postoperative nausea and vomiting. The provision of effective postoperative analgesia is of key importance to facilitate early ambulation and prevention of postoperative morbidity. The analgesic regimen needs to meet the goals of providing safe, effective analgesia, with minimal side effects. Many additives to local anesthetics used to prolong the duration of analgesia for peripheral nerve blocks have been studied as dexamethasone, dexmedetomidine Dexmedetomidine is a lipophilic α2 agonist derivative with a higher affinity for α2-receptors than clonidine (α2: α1 specificity ratio is 200:1 for clonidine and 1600:1 for dexmedetomidine). It has sedative, analgesic, and sympatholytic effects that blunt many of the cardiovascular responses seen during the perioperative period. Animal and human studies have shown safety and efficacy of adding dexmedetomidine to local anesthetics in various regional anesthetic procedures. The addition of dexmedetomidine to bupivacaine in TAP block achieves better local anesthesia and provides better pain control postoperatively without any major side-effects.
Dexamethasone is a systemic glucocorticoid that improves the quality of recovery after surgery by reducing pain, nausea, and vomiting. When added to local anesthetics as an adjuvant in peripheral blocks, it prolongs the analgesia time. Mechanism of action may be through the anti-inflammatory action, the increase of the local efficiency, and to slow down of the absorption.
Objective:
The objective is to compare and evaluate efficacy and safety of dexmedetomidine and dexamethasone as a local anesthetic adjuvant to bupivacaine in ultrasound-guided TAP block for patients scheduled for total abdominal hysterectomies.
详细描述
PATIENTS AND METHODS:
This study will be performed on Fifty-four adult patients who will be undergone an abdominal hysterectomy after obtaining the approval of the local ethical committee and scientific institutional review board. written informed consents will be signed from each patient before enrollment and randomization into the study.
The patients will be randomly allocated to receive either a mixture of bupivacaine and dexamethasone 8 mg (group A, 27 patients) or a mixture of bupivacaine and dexmedetomidine 80 µg (group B, 27 patients). Randomization will be performed by using a computer-generated random number list. The random number for each patient will be concealed in opaque sealed envelope which will be opened by the investigators shortly after the admission of the patient into the operation room. The investigators sharing in the patients care and data acquisition will be blinded to groups allocation till full completion of statistical analysis.
Preoperative preparation:
Visual analog scale (VAS) will be explained to all the patients on preoperative visit (0-10 cm, in which 0 cm = no pain and 10 cm = worst pain) and the compulsory investigations according to the regular institutional protocol will be done [electrocardiogram (ECG), complete blood count (CBC), blood sugar level, serum urea and creatinine, liver function tests, and coagulation profile].
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- Female
- 接受健康志愿者
- 否
入选标准
- •American society of anesthesiologists (ASA) physical status grade 1 and
- •Age of 18 years and more.
- •Patients who will be scheduled for total abdominal hysterectomies.
排除标准
- •Patient refusal.
- •Body mass index (BMI) >
- •Patients with chronic pain and those using chronic analgesic medications.
- •Coagulopathy.
- •Allergy to the study drugs.
- •Patients taking other medications with α-adrenergic blocking effect.
- •Hepatic or renal insufficiency.
- •Systemic infection.
- •Infection at the site of injection.
研究组 & 干预措施
Dexamethasone arm (group A)
The local anesthetic solution mixture consists of dexamethasone 8 mg in Bupivacaine 0.25% Injectable Solution to a total volume of 40 ml (19 ml bupivacaine 0.5 % + 19 ml normal saline + 2 ml dexamethasone = 40ml). 20 ml of the local anesthetic solution mixture will be injected on each side.The Transversus abdominis Plane (TAP) block will be performed once after induction of anesthesia.
干预措施: dexamethasone 8 mg (Drug)
Dexamethasone arm (group A)
The local anesthetic solution mixture consists of dexamethasone 8 mg in Bupivacaine 0.25% Injectable Solution to a total volume of 40 ml (19 ml bupivacaine 0.5 % + 19 ml normal saline + 2 ml dexamethasone = 40ml). 20 ml of the local anesthetic solution mixture will be injected on each side.The Transversus abdominis Plane (TAP) block will be performed once after induction of anesthesia.
干预措施: Bupivacaine 0.25% Injectable Solution (Drug)
Dexmedetomidine arm (group B)
The local anesthetic solution mixture consists of dexmedetomidine 80 µg in Bupivacaine 0.25% Injectable Solution to a total volume of 40 ml (19 ml bupivacaine 0.5 % + 19 ml normal saline + 80 µg dexmedetomidine in 2 ml = 40ml). 20 ml of the local anesthetic solution mixture will be injected on each side.The Transversus abdominis Plane (TAP) block will be performed once after induction of anesthesia.
干预措施: dexmedetomidine 80 µg (Drug)
Dexmedetomidine arm (group B)
The local anesthetic solution mixture consists of dexmedetomidine 80 µg in Bupivacaine 0.25% Injectable Solution to a total volume of 40 ml (19 ml bupivacaine 0.5 % + 19 ml normal saline + 80 µg dexmedetomidine in 2 ml = 40ml). 20 ml of the local anesthetic solution mixture will be injected on each side.The Transversus abdominis Plane (TAP) block will be performed once after induction of anesthesia.
干预措施: Bupivacaine 0.25% Injectable Solution (Drug)
结局指标
主要结局
Time to first request of analgesia
时间窗: During the 24 hours postoperatively
The time passed till the patient request an analgesic dose
次要结局
- Visual Analog Scale (VAS) at rest(Assesment will be done at 48 hours postoperatively)
- Visual Analog Scale (VAS) on movement(Assesment will be done at 48 hours postoperatively)
- Interval doses of consumed morphia(During 24 - 48 hours postoperatively)
- Cumulative doses of consumed morphia(During the 24 hours postoperatively)
- Intraoperative fentanyl consumption(At the end of surgical procedure)
- Nausea(During the 48 hour postoperatively)
- Vomiting(During the 48 hour postoperatively)
- Sedation score(At 48 hours postoperatively)
- Hypotension(During 48 hours postoperatively)
- Bradycardia(During 48 hours postoperatively)
研究者
Hany Mahmoud Yassin
Dr.
Fayoum University Hospital