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临床试验/NCT05840406
NCT05840406已完成不适用

Effect of a Transversus Abdominis Plane Block on Operative Wound Healing, Stress, and Immune Response After a Cesarean Delivery

University Hospital Sestre Milosrdnice1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2024年9月3日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
105
试验地点
1
主要终点
Wound healing

研究概览

简要总结

The primary purpose of this study is to determine whether the addition of a TAP block to standard analgesia after the cesarean delivery will impact postoperative wound healing and attenuate postoperative stress and immune response.

Random allocation of participants in 3 groups: group SA (standard analgesia), group L (TAP block with levobupivacaine), and group D (TAP block with levobupivacaine + dexmedetomidine). All participants will undergo elective cesarean section through Pfannestiel incision under spinal anesthesia. They will receive standard postoperative pain management with acetaminophen, nonsteroidal anti-inflammatory drugs, and tramadol. Groups L and D will additionally receive bilateral ultrasound-guided TAP block with 20 ml 0,25% levobupivacaine or with 20 ml 0,25% levobupivacaine with the addition of 0,5 μg/kg dexmedetomidine. TAP block will be performed in the theatre immediately after the cesarean delivery.

Venous blood samples will be collected before the surgery and on the third postoperative day. Complete blood count and serum cortisol levels will be measured. REEDA scale will be used for assessing wound healing.

详细描述

Introduction. Cesarean section is one of the world's most frequently performed surgical procedures. It is often accompanied by severe postoperative pain that leads to a complex immune and stress response in the body. Neutrophil to lymphocyte ratio (NLR) and platelet to lymphocyte ratio (PLR) are reliable and readily available markers of immune response to various infectious and non-infectious stimuli. Elevated NLR and PLR values are predictive in the early detection of wound infection after cesarean section. Wound healing involves three stages: inflammation, proliferation, and remodeling. REEDA scale is a valid tool for assessing obstetric wound healing. Many factors can affect the wound-healing process. Consistent overlap between pain-related dysregulation of neuroendocrine and immune function and the aspects of the neuroendocrine and immune function shown to be critical in wound healing suggests that pain may play a role in delayed wound healing. Therefore, it is reasonable to assume that better postoperative analgesia could positively affect wound healing. According to previous research, the transversus abdominis plane (TAP) block significantly reduces pain and cortisol, epinephrine, and norepinephrine levels after cesarean section. The addition of dexmedetomidine to the local anesthetic in the TAP block has a more pronounced analgesic effect and prolongs the duration of analgesia. The investigators have found only one study that demonstrates that adding a TAP block to standard analgesia positively affects wound healing after cesarean delivery. In the literature search, investigators did not find any clinical study that has been carried out to see the influence of the addition of dexmedetomidine in TAP block on wound healing, stress response, and immune response after cesarean delivery.

We hypothesize that the use of bilateral transversus abdominis plane block after cesarean delivery will lead to lower values of the REEDA scale and attenuated stress and immune response of the patient compared to standard analgesia, where the addition of dexmedetomidine to levobupivacaine will have a more pronounced effect compared to TAP block with levobupivacaine.

Patients and methods: This prospective, randomized study will be conducted in the Department of Anesthesiology, Intensive Care Medicine and Pain Management and the Department of Gynecology and Obstetrics in the Sestre Milosrdnice University Hospital Center. A total of 120 participants will be included in the study.

The group size was obtained by power analysis. For each variable, the sample size required for cross-comparisons of the arithmetic means of the three groups was calculated using a two-tailed t-test with the power of the test β = 85%, and the level of statistical significance for each test, α = 1.667%. Standard deviations and expected differences in the arithmetic means of the examined groups were taken from the published literature. (2:24-26). The largest estimated sample size for the investigated variables is 35 subjects per group.

After the written and signed approval of the patients, they will be randomly allocated to either a control group that receives the standard postoperative analgesia (group SA) or groups that further receive the TAP block with levobupivacaine (group L), with and without the addition of dexmedetomidine (group D). All the participants will undergo elective cesarean delivery under spinal anesthesia. The classic cesarean section technique described by Pfannenstiel and Kerr technique will be performed on all the participants. The spinal anesthesia will be performed with an atraumatic spinal needle by applying height- and weight-adjusted dose of hyperbaric bupivacaine and 25 μg fentanyl intrathecally. All the participants will receive standard postoperative analgesia according to the Acute Pain Service Sestre Milosrdnice University Hospital Center (acetaminophen, tramadol, and nonsteroidal anti-inflammatory drugs). Group L and group D will additionally receive a bilateral TAP block. 20 ml of 0,25 % levobupivacaine will be administered on each side to the participants in group L and 20 ml of 0,25 % levobupivacaine with the addition of 0,5 μg/kg dexmedetomidine will be administered on each side to the participants in group D. TAP block will be performed under sterile conditions. The high-frequency linear probe will be placed transversally in the medial axillary line, and the three layers of abdominal muscles will be visualized. A 22G echogenic needle for peripheral nerve blocks will be used to inject the mixed solution in the plane between the transversus abdominis and internal oblique muscles.

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)

盲法说明

Participants will be randomly allocated to either a group SA receiving the standard postoperative analgesia or groups receiving the TAP block with levobupivacaine (group L) or levobupivacaine with the addition of dexmedetomidine (group D). The allocation sequence will be generated by a random number table. After signing an informed consent, participants and an anesthesiologist performing the TAP block will be informed about patients' group allocation. An independent observer, who will not know which group the participant belongs to, will assess wound healing using the standardized REEDA scale 72 hours after the cesarean delivery. The same independent observer will assess every participant at 4, 8, 12, 18, 24, and 72 hours after surgery for pain by using the pain numerical rating scale.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients scheduled for the elective cesarean section through Pfannenstiel incision under spinal anesthesia
  • American Society of Anesthesiologists (ASA) physical status II
  • Body mass index < 40 mg/kg²
  • >35 gestational weeks

排除标准

  • participant's refusal to participate in the study
  • ASA physical status >II
  • emergency cesarean section
  • twin or triplets pregnancy
  • history of allergy to the local anesthetic or any other drug used in this study (dexmedetomidine, acetaminophen, tramadol, nonsteroidal anti-inflammatory drugs)
  • contraindications for spinal anesthesia or TAP block
  • Drop out from the study:
  • the change in anesthetic technique from spinal to the general anesthesia
  • the need for the blood transfusion
  • acute mastitis, puerperal endometritis, and/or wound infection developed in the first 72 hours postoperatively
  • failed TAP block

研究组 & 干预措施

Group SA

Active Comparator

No TAP block applied.

干预措施: Postoperative pain management with acetaminophen (Drug)

Group SA

Active Comparator

No TAP block applied.

干预措施: Postoperative pain management with tramadol (Drug)

Group SA

Active Comparator

No TAP block applied.

干预措施: Postoperative pain management with ketoprofen (Drug)

Group SA

Active Comparator

No TAP block applied.

干预措施: Postoperative pain management with ibuprofen (Drug)

Group L

Experimental

Ultrasound-guided bilateral TAP block (in-plane technique) will be performed in this group. Levobupivacaine 0.25 % 20 ml will be administered in the block on each side.

干预措施: Postoperative pain management with acetaminophen (Drug)

Group L

Experimental

Ultrasound-guided bilateral TAP block (in-plane technique) will be performed in this group. Levobupivacaine 0.25 % 20 ml will be administered in the block on each side.

干预措施: Bilateral TAP Block with levobupivacaine (Procedure)

Group L

Experimental

Ultrasound-guided bilateral TAP block (in-plane technique) will be performed in this group. Levobupivacaine 0.25 % 20 ml will be administered in the block on each side.

干预措施: Postoperative pain management with tramadol (Drug)

Group L

Experimental

Ultrasound-guided bilateral TAP block (in-plane technique) will be performed in this group. Levobupivacaine 0.25 % 20 ml will be administered in the block on each side.

干预措施: Postoperative pain management with ketoprofen (Drug)

Group L

Experimental

Ultrasound-guided bilateral TAP block (in-plane technique) will be performed in this group. Levobupivacaine 0.25 % 20 ml will be administered in the block on each side.

干预措施: Postoperative pain management with ibuprofen (Drug)

Group D

Experimental

Ultrasound-guided bilateral TAP block (in-plane technique) will be performed in this group. Levobupivacaine 0.25 % 20 ml + dexmedetomidine 0,5 μg/kg will be administered in the block on each side.

干预措施: Postoperative pain management with acetaminophen (Drug)

Group D

Experimental

Ultrasound-guided bilateral TAP block (in-plane technique) will be performed in this group. Levobupivacaine 0.25 % 20 ml + dexmedetomidine 0,5 μg/kg will be administered in the block on each side.

干预措施: Bilateral TAP Block with levobupivacaine and dexmedetomidine (Procedure)

Group D

Experimental

Ultrasound-guided bilateral TAP block (in-plane technique) will be performed in this group. Levobupivacaine 0.25 % 20 ml + dexmedetomidine 0,5 μg/kg will be administered in the block on each side.

干预措施: Postoperative pain management with tramadol (Drug)

Group D

Experimental

Ultrasound-guided bilateral TAP block (in-plane technique) will be performed in this group. Levobupivacaine 0.25 % 20 ml + dexmedetomidine 0,5 μg/kg will be administered in the block on each side.

干预措施: Postoperative pain management with ketoprofen (Drug)

Group D

Experimental

Ultrasound-guided bilateral TAP block (in-plane technique) will be performed in this group. Levobupivacaine 0.25 % 20 ml + dexmedetomidine 0,5 μg/kg will be administered in the block on each side.

干预措施: Postoperative pain management with ibuprofen (Drug)

结局指标

主要结局

Wound healing

时间窗: 72 hours after the surgery

Wound healing will be assessed 72 hours after cesarean delivery using a standardized REEDA scale. REEDA includes five factors associated with the healing of an incision: redness, edema, ecchymosis, discharge, and approximation of the two edges of the wound, each receiving a score between 0-3, with a higher score indicating a greater level of tissue trauma and less healed wound compared to lower scores.

Measure the stress response (serum cortisol)

时间窗: up to 72 hours

Venous blood samples will be collected at 7 a.m. on the day of surgery and at 7 a.m. on the 3rd postoperative day. Serum cortisol levels will be measured by using electrochemiluminescence immunoassay (ECLIA).

Measure immune response (neutrophil to lymphocyte ratio)

时间窗: up to 72 hours

The neutrophil to lymphocyte ratio will be calculated as a simple ratio between absolute neutrophil and lymphocyte counts measured in peripheral blood. Venous blood samples will be collected the day before the surgery at the admission and at 7 a.m. on the third postoperative day.

Measure immune response (platelet to lymphocyte ratio)

时间窗: up to 72 hours

The platelet to lymphocyte ratio will be calculated as a simple ratio between absolute platelet and lymphocyte counts measured in peripheral blood. Venous blood samples will be collected the day before the surgery at the admission and at 7 a.m. on the third postoperative day.

次要结局

  • Postoperative pain score(4, 8, 12, 18, 24, and 72 hours after surgery)
  • Quality of recovery(24 hours after the surgery)

研究者

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

Mirta Ciglar, MD

Principal Investigator

University Hospital Sestre Milosrdnice

研究点 (1)

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