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临床试验/NCT07384000
NCT07384000尚未招募不适用

The Efficacy of Single Puncture Technique of Rectus Sheath Block Combined With Transversus Abdominis Plane Block Versus External Oblique Intercostal Plane Block for Pain Control After Laparoscopic Cholecystectomy.

Minia University0 个研究点目标入组 60 人开始时间: 2026年1月20日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
主要终点
Decrase the consumption of opioids

研究概览

简要总结

Effective perioperative pain management remains a cornerstone in enhancing recovery and improving patient outcomes in laparoscopic cholecystectomy. This minimally invasive procedure, although less traumatic compared to open surgery, can still lead to significant postoperative pain, particularly in the early hours following the operation. Insufficient pain control may result in delayed mobilization, prolonged hospital stays, and increased opioid consumption, which are associated with adverse side effects and a heightened risk of complications . Regional anesthesia techniques have garnered significant attention for their ability to provide localized, opioid-sparing analgesia, thereby improving postoperative recovery profiles.External Oblique Intercostal Plane Block (EOIP) is a relatively new regional anesthesia technique targeting the intercostal nerves (T7-T11) as they traverse the plane between the external and internal oblique muscles. This block has demonstrated efficacy in controlling postoperative pain for upper abdominal surgeries, including laparoscopic cholecystectomy. By selectively anesthetizing the sensory branches of the thoracoabdominal nerves, the EOIP block provides localized analgesia with minimal motor blockade, making it an ideal choice for early mobilization (Ouchi et al., 2020).Recent advancements in ultrasound-guided techniques have improved the precision and safety of the EOIP block, allowing for consistent blockade of the targeted nerves. Clinical trials have highlighted its ability to reduce the pain significantly in the first 24 hours postoperatively, along with a marked decrease in the need for rescue analgesics. Tranrversus abdominis plane block (TAP) , first described in the early 2000s, has undergone several modifications to improve its efficacy in abdominal surgeries. The subcostal TAP block targets the anterior branches of the lower thoracic nerves (T6-T9) to provide analgesia to the upper abdominal wall. This technique is particularly suited for laparoscopic cholecystectomy, where the pain originates predominantly from the pari0etal peritoneum and abdominal wall incisions.The single puncture technique of Rectus sheath block (RSB) combined with transversus abdominis plane block (TAPB) represents a more streamlined approach to abdominal wall analgesia. ultrasonography (US) guidance for peripheral nerve blocks has become more and more popular. Transversus abdominis plane block (TAPB) and US-guided rectus sheath block (RSB) have been utilized in abdominal surgeries and have shown strong analgesic effects. Prior researches has demonstrated that in abdominal surgery, US-guided (TAPB) in conjunction with (RSB) had superior analgesic effects than either (TAPB) or (RSB) alone. Currently, multipoint nerve block procedures are generally applied in clinical practice, but they are difficult and can increase the patient's suffering. A novel method is proposed based on the neuromuscular anatomy and the location of the incisiopn in laparoscopic upper abdominal surgery: US-guided transverse abdominis plane and rectus sheath block one-puncture .

详细描述

This study aims to investigate the analgesic efficacy of external oblique intercostal plane (EOIPB) versus single puncture technique of rectus sheath block (RSB) combined with transversus abdominis plane block (TAPB) after laparoscopic cholecystectomy.

Primary Outcome:

The primary outcome of the study will be the amount of opoid (nalbuphine) consumption in the first 24 hours postoperatively.

Secondary Outcomes:

the analgesic efficacy (Sensory assessment) by defined dermal zones in the first 24 hours postoperatively.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

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

入选标准

  • Patients undergoing elective laparoscopic cholecystectomy
  • American Society of Anesthesiologists (ASA) 1-II
  • aged 18-70 years
  • both genders will be included.
  • body mass index (BMI) ≤ 35 kg/m2.

排除标准

  • coagulation disorders
  • liver/kidney disease
  • History of abdominal surgery
  • infection in the block application area
  • chronic opioid use
  • local anesthetic (LA) allergy
  • Pregnancy

研究组 & 干预措施

external intercostal plane block intervention with ultra sound

Active Comparator

Patients in this group will receive (EOIPB) bilaterally, the block will be performed under ultrasound guidance after induction of general anesthesia using 20 ml of 0.25% bupivacaine injected into the external oblique intercostal plane on each side.

干预措施: External intercostal plane puncture (Procedure)

single-puncture technique of (RSB) combined with (TAPB) by ultra sound

Active Comparator

Patients in this group will receive rectus sheath block (RSB) combined with transversus abdominis plane block (TAPB) bilaterally via single puncture, the block will be performed under ultrasound guidance after induction of general anesthesia using 20 ml of 0.25% bupivacaine divided into 10 ml of 0.25% bupivacaine will be injected when the needle reaches the posterior rectus abdominis sheath and pierces the anterior layer of the posterior sheath, Then, the needle will break through the posterior layer of the tendon to the transversus abdominis plane and another 10 ml of 0.25% bupivacaine will be injected into transversus abdominis plane .

干预措施: the single-puncture technique of (rectus sheath block) combined with (Transversus abdominis plane block) (Procedure)

control group (nalbuphine)

Placebo Comparator

Patients in this group will not receive any intervention or nerve block.

干预措施: control group (nalbuphine) (Drug)

结局指标

主要结局

Decrase the consumption of opioids

时间窗: Intraoperative, immediately postoperative , 2 hours post operative , 4 hours post operative , 6 hours postoperative, 12 hours postoperative, 24 hours postoperative

The primary outcome of the study will be the amount of opoid (nalbuphine) consumption in the first 24 hours postoperatively.

次要结局

  • The analgesic efficacy (sensory assessment)(First hour, second hour , sixth hour, 12th hour , 24th hour postoperatively)
  • Pain intensity(Immediately postoperative, 2 hours postoperative, 4 hours postoperatively, 6 hours postoperative, 12 hours postoperative, 24 hours postoperative)
  • Off bed activity(24 hours postoperative)

研究者

发起方
Minia University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Osama Mohamed Hassan

Principal investigator

Minia University

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