A Prospective, Randomized Controlled Study Comparing the Analgesic Efficacy of Bupivacaine Infiltration of the Gallbladder Bed and Trocar Sites, Erector Spinae Plane Block, and Intrathecal Morphine in Patients Undergoing Laparoscopic Cholecystectomy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Total Opioid Consumption in the First 24 Hours
研究概览
简要总结
This study is designed to compare three different methods of pain control after laparoscopic gallbladder surgery (laparoscopic cholecystectomy). Although this surgery is minimally invasive, participants often experience different types of pain after the operation, such as pain at the incision site, pain inside the abdomen, and shoulder pain caused by the gas used during surgery.
The investigators will compare three commonly used pain relief techniques:
Local infiltration - injecting a numbing medicine (bupivacaine) into the gallbladder bed and at the sites where the surgical instruments are placed.
Erector spinae plane (ESP) block - an ultrasound-guided nerve block performed in the back to reduce both abdominal and incisional pain.
Intrathecal morphine - a very small dose of morphine given into the spinal fluid before surgery to provide long-lasting pain relief.
The goal is to determine which method provides the best pain control, reduces the need for opioid medications, and improves recovery after surgery.
详细描述
Laparoscopic cholecystectomy is the standard surgical treatment for gallbladder diseases. Despite being a minimally invasive procedure, postoperative pain is a frequent problem and can negatively affect early mobilization, oral intake, and overall recovery. The pain experienced after this surgery is multifactorial, including somatic pain at trocar sites, visceral pain at the gallbladder bed, and shoulder pain caused by carbon dioxide insufflation. Effective pain management is therefore essential to improve patient comfort, reduce opioid consumption, and shorten hospital stay.
Several methods are available for postoperative analgesia. Local infiltration of the gallbladder bed and trocar sites with bupivacaine provides targeted pain relief at areas of surgical trauma. Erector spinae plane (ESP) block, a recently described ultrasound-guided regional anesthesia technique, offers both somatic and visceral analgesia with a favorable safety profile. Low-dose intrathecal morphine has also been shown to provide strong and prolonged analgesia in abdominal surgery, though its use may be limited by side effects such as nausea, vomiting, and itching.
This single-center, prospective, randomized controlled trial will compare the analgesic efficacy of three techniques:
Group INF (Infiltration): Bupivacaine infiltration at the gallbladder bed and trocar sites.
Group ESP: Bilateral ultrasound-guided ESP block at the T7 level.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and postoperative outcome assessors will be blinded to group allocation. The anesthesiologist performing the intervention cannot be blinded due to the nature of the procedures, but will not be involved in postoperative data collection or outcome assessment. Thus, the trial will be conducted with patient- and assessor-blinding to minimize bias.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-65 years
- •Scheduled for elective laparoscopic cholecystectomy
- •American Society of Anesthesiologists (ASA) physical status I-III
- •Able to provide written informed consent
排除标准
- •Body mass index (BMI) > 35 kg/m²
- •History of coagulopathy or bleeding disorders
- •Known allergy or hypersensitivity to opioids or local anesthetics
- •Chronic pain or regular analgesic use
- •History of neurological or psychiatric disease
- •Pregnancy
- •Refusal to participate in the study
研究组 & 干预措施
Bupivacaine Infiltration Group
Patients will receive bupivacaine infiltration at the gallbladder bed and trocar sites following laparoscopic cholecystectomy. After removal of the gallbladder, 20 mL of 0.25% bupivacaine will be applied to the gallbladder bed using a sterile sponge for 10-15 minutes. At the end of surgery, a total of 20 mL 0.25% bupivacaine will be infiltrated at trocar insertion sites (8 mL umbilical port, 6 mL epigastric port, 3 mL each auxiliary port).
干预措施: Bupivacaine Infiltration (Drug)
Erector Spinae Plane Block Group
Patients will undergo bilateral erector spinae plane block under ultrasound guidance before induction of anesthesia. Under ultrasound guidance at the T7 transverse process level, a total of 40 mL of 0.25% bupivacaine will be injected bilaterally using an in-plane technique prior to induction of anesthesia.
干预措施: Erector Spinae Plane Block (Procedure)
Intrathecal Morphine Group
Patients will receive intrathecal morphine prior to induction of anesthesia. With the patient in a sitting position, a 27G spinal needle will be inserted at the L3-L4 interspace, and 200 mcg of morphine will be administered intrathecally before induction of anesthesia.
干预措施: Intrathecal Morphine (Drug)
结局指标
主要结局
Total Opioid Consumption in the First 24 Hours
时间窗: 0-24 hours postoperatively
The cumulative amount of opioid analgesic (fentanyl via patient-controlled analgesia device) used by each patient during the first 24 hours after laparoscopic cholecystectomy. This measure will evaluate the effectiveness of each intervention in reducing postoperative opioid requirement.
次要结局
- Postoperative Pain Scores (Visual Analog Scale, VAS)(At 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24 hours postoperatively)
- Incidence of Postoperative Nausea and Vomiting (PONV)(0-24 hours postoperatively)
- Incidence of Pruritus(0-24 hours postoperatively)
- Incidence of Respiratory Depression(0-24 hours postoperatively)
研究者
irem ateş
Associate Professor as the Principal Investigator
Ataturk University