Effect of Two Different Bupivacaine Concentrations in Rectus Intercostal Fascial Plane Block on Postoperative Analgesia After Laparoscopic Cholecystectomy: A Randomized, Controlled, Double-Blind Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Total rescue tramadol consumption during the first 24 postoperative hours
研究概览
简要总结
Pain after laparoscopic cholecystectomy remains a clinically relevant problem despite the minimally invasive nature of the procedure, and current recommendations favour multimodal, opioid-sparing analgesia including regional techniques. The rectus intercostal fascial plane block (RIFPB) is a recently described interfascial technique in which local anesthetic is injected into the plane between the rectus abdominis muscle and the 6th and 7th costal cartilages, targeting the anterior and lateral cutaneous branches of the T6-T9 thoracoabdominal nerves.
In a previous randomized controlled trial conducted at the investigators' institution, bilateral RIFPB after laparoscopic cholecystectomy significantly reduced the need for rescue analgesia (17.9% versus 55.3%) and pain scores during the first 12 postoperative hours. That trial, however, used 30 mL of 0.25% bupivacaine per side (60 mL, 150 mg in total), a dose approaching the recommended upper limit, and its limitations section highlighted the need to determine whether comparable analgesia can be achieved with lower doses. Because the efficacy of fascial plane blocks depends on the spread of local anesthetic, large volumes are preferred, which increases total dose and the risk of local anesthetic systemic toxicity (LAST); reducing concentration as volume increases has therefore been recommended.
Equal-volume comparisons in transversus abdominis plane and erector spinae plane blocks suggest that lower local anesthetic concentrations provide comparable analgesia. No study has yet compared different concentrations for RIFPB.
The aim of this trial is to compare, at a fixed volume of 30 mL per side (60 mL in total), bilateral RIFPB performed with 0.25% bupivacaine, bilateral RIFPB performed with 0.125% bupivacaine, and routine analgesic management with port-site infiltration (control), in adults undergoing elective laparoscopic cholecystectomy under general anesthesia. Ninety patients will be randomly allocated in a 1:1:1 ratio.
The primary outcome is total rescue tramadol consumption during the first 24 postoperative hours. Secondary outcomes are numeric rating scale (NRS) pain scores at rest and on movement, the proportion of patients requiring rescue analgesia, time to first rescue analgesic, the incidence of nausea, vomiting and pruritus, block-related complications and signs of LAST, patient satisfaction, and length of hospital stay.
The investigators hypothesize that RIFPB at either concentration will reduce postoperative analgesic consumption and pain scores compared with the control group, and that the lower concentration will provide comparable analgesia while halving the total bupivacaine dose (75 mg instead of 150 mg) and thereby reducing the risk of LAST.
详细描述
Design. This is a prospective, randomized, double-blind (participant and outcomes assessor), controlled, single-centre trial to be conducted at Istanbul Medipol University Mega Hospital Complex after approval by the institutional ethics committee, in accordance with the Declaration of Helsinki, and registered prospectively on ClinicalTrials.gov. Written informed consent will be obtained from all participants.
Randomization and blinding. Before transfer to the operating room, patients will be allocated in a 1:1:1 ratio to one of three groups using a sequence generated with the Research Randomizer program. Study solutions for the two block groups will be prepared by an anesthesiologist not otherwise involved in the trial and supplied in identical, indistinguishable syringes labelled only with the randomization number (Group Y: 30 mL of 0.5% bupivacaine + 30 mL of 0.9% saline; Group D: 15 mL of 0.5% bupivacaine + 45 mL of 0.9% saline). As both solutions are clear, the anesthesiologist performing the block is also blinded to the concentration. All procedures are performed under general anesthesia, so participants are unaware of their allocation. All postoperative assessments will be performed by an anesthesiologist blinded to group allocation who takes no part in the intervention.
Groups. Group Y receives bilateral RIFPB with 30 mL of 0.25% bupivacaine per side (60 mL, 150 mg in total). Group D receives bilateral RIFPB with 30 mL of 0.125% bupivacaine per side (60 mL, 75 mg in total). Group K (control) receives no block and is managed with the institution's routine analgesic protocol, including port-site infiltration with 30 mL of 0.25% bupivacaine performed by the surgical team. Total volume is held constant in both block groups; only the administered dose differs. To allow the isolated effect of the block to be assessed, port-site infiltration is not performed in the block groups. The total bupivacaine dose will not exceed 2.5 mg/kg in any group.
Anesthesia and surgery. After premedication with 2 mg of intravenous midazolam, general anesthesia will be induced with propofol (2-2.5 mg/kg), fentanyl (1-1.5 mcg/kg) and rocuronium (0.6 mg/kg), and maintained with sevoflurane and a remifentanil infusion (0.05-2 mcg/kg/min). Surgery will be performed by the same team using the conventional four-port technique. All patients will receive 4 mg of ondansetron for nausea prophylaxis, and 400 mg of ibuprofen and 100 mg of tramadol approximately 20 minutes before skin closure.
Block technique. The block will be performed bilaterally at the end of surgery, before extubation, with the patient supine and under general anesthesia. Using a high-frequency linear ultrasound probe (11-12 MHz) and an 80 mm block needle, the probe will be placed 3-4 cm lateral and caudal to the epigastrium to visualize the rectus abdominis muscle and the 6th and 7th costal cartilages. After hydrodissection with 5 mL of saline using an in-plane technique, 30 mL of the study solution will be injected on each side. Aspiration will be performed before injection, the drug will be given in fractionated doses, patients will be continuously monitored, and 20% lipid emulsion will be immediately available in the operating room.
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
All interventions are performed under general anesthesia, so participants are unaware of their group allocation. Study solutions for the two block groups are prepared by an anesthesiologist not otherwise involved in the trial and supplied in identical, indistinguishable syringes labelled only with the randomization number; because both solutions are clear, the anesthesiologist performing the block is also blinded to the bupivacaine concentration. All postoperative assessments are performed by an anesthesiologist blinded to group allocation who takes no part in the intervention. The operating-room team cannot be blinded to the presence or absence of a block, and therefore cannot be blinded to the control group.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled for elective laparoscopic cholecystectomy under general anesthesia
- •Aged between 18 and 65 years
- •American Society of Anesthesiologists (ASA) physical status I or II
- •Body weight above 60 kg
- •Able and willing to provide written informed consent
排除标准
- •Known allergy or hypersensitivity to local anesthetics or opioids
- •Coagulopathy or ongoing anticoagulant therapy
- •Infection at the site of block injection
- •Alcohol or substance dependence, or chronic opioid use
- •Pregnancy or lactation
- •Advanced hepatic or renal failure
- •Any condition preventing the participant from understanding and using the - numeric rating scale
- •Refusal to participate
研究组 & 干预措施
Group Y - RIFPB with 0.25% bupivacaine
Bilateral ultrasound-guided rectus intercostal fascial plane block performed under general anesthesia at the end of surgery, before extubation, with 30 mL of 0.25% bupivacaine per side (60 mL, 150 mg in total). Port-site infiltration is not performed. All participants receive the standard multimodal analgesia protocol and rescue intravenous tramadol 0.5-1 mg/kg whenever the NRS score is 4 or higher.
干预措施: Bupivacaine 0.25% - rectus intercostal fascial plane block (Drug)
Group D - RIFPB with 0.125% bupivacaine
Bilateral ultrasound-guided rectus intercostal fascial plane block performed under general anesthesia at the end of surgery, before extubation, with 30 mL of 0.125% bupivacaine per side (60 mL, 75 mg in total). The injected volume is identical to that of Group Y; only the administered dose differs. Port-site infiltration is not performed. All participants receive the standard multimodal analgesia protocol and rescue intravenous tramadol 0.5-1 mg/kg whenever the NRS score is 4 or higher.
干预措施: Bupivacaine 0.125% - rectus intercostal fascial plane block (Drug)
Group K - Control (port-site infiltration)
No fascial plane block is performed. Patients are managed with the institution's routine analgesic protocol, including port-site infiltration with 30 mL of 0.25% bupivacaine performed by the surgical team. All participants receive the standard multimodal analgesia protocol and rescue intravenous tramadol 0.5-1 mg/kg whenever the NRS score is 4 or higher.
干预措施: Bupivacaine 0.25% - port-site infiltration (Drug)
结局指标
主要结局
Total rescue tramadol consumption during the first 24 postoperative hours
时间窗: 0 to 24 hours after extubation
Cumulative dose of intravenous tramadol administered as rescue analgesia (milligrams) during the first 24 hours after extubation. Rescue tramadol 0.5-1 mg/kg intravenously is administered whenever the numeric rating scale (NRS) score is 4 or higher.
次要结局
- Pain intensity at rest measured with the Numeric Rating Scale (NRS)(1, 3, 6, 12, 18 and 24 hours after extubation)
- Pain intensity on movement measured with the Numeric Rating Scale (NRS)(1, 3, 6, 12, 18 and 24 hours after extubation)
- Proportion of participants requiring rescue analgesia(0 to 24 hours after extubation)
- Time to first rescue analgesic request(0 to 24 hours after extubation)
- Incidence of postoperative nausea and vomiting(0 to 24 hours after extubation)
- Incidence of pruritus(0 to 24 hours after extubation)
- Incidence of block-related complications and signs of local anesthetic systemic toxicity (LAST)(From performance of the block until 24 hours after extubation)
- Patient satisfaction with postoperative analgesia(At 24 hours after extubation)
- Length of hospital stay(From end of surgery until hospital discharge, assessed up to 7 days)
研究者
Burak Omur
Assistant Professor of Anesthesiology and Reanimation
Medipol University