Effect of Transversus Abdominis Plane (TAP) Block and the Perioperative Stress Response: Randomized Control Trial in Patient Undergoing Total Abdominal Hysterectomy in a Tertiary Care Hospital of Pakistan
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Serum Norepinephrine
研究概览
简要总结
Random allocation of patients in two groups; Tap block group (T group) and control group (C group). All patients will receive standard general anesthesia and postoperative pain management. The TAP group patient will receive ultrasound guided (US) TAP block with 20 cc of 0.25% of bupivacaine and control group will receive 20cc of normal saline. TAP block in both groups will be performed with US guidance and the study drug will be injected after complete visualization of the needle tip between the internal oblique and the transversus abdominis muscles.
Venous blood samples (5 ml for each time) for metabolic and stress hormones, including, Serum cortisol and nor-epinephrine will be collected before anesthesia at the time of cannulation (T1),60 minutes after incision(T2), 6hrs (T3)and 12 h (T4) after the surgery.
Postoperatively patient will be put on patient controlled intravenous infusion of nalbuphine
详细描述
Total abdominal hysterectomy (TAH) is a commonly performed major surgical procedure that results in substantial postoperative pain and discomfort. It has been shown that surgical pain and trauma can lead to a number of hormonal changes initiated by the neuronal activation of the hypothalamic pituitary-adrenal axis and the sympathetic nervous system, which can have a detrimental effect on the patient. Strenuous effort has been made to inhibit the stress response to surgery and evaluate its outcome.
It has been shown that this stress response is influenced by the mode of anesthesia and postoperative analgesia. A surgery induced stress response blunted by regional technique and the potential benefits of regional analgesia on surgical outcome are still under scrutiny. Among the postoperative analgesic technique, epidural analgesia has shown to significantly abolish the perioperative stress responses after number of surgeries including hysterectomy. In Pakistan only a small proportion of women wants to avail the epidural service due to fears and misconception.
Another modality of regional technique that has gained popularity as a part of multimodal analgesia is transversus abdominis plane (TAP) block. It is a newly developed block involving the nerves of the anterior abdominal wall. The abdominal wall sensory afferents course through the transversus abdominis plane superficial to the transversus abdominis muscle. An important component of the pain experienced by patients after abdominal surgery derives from the abdominal wall incision.
The efficacy of the TAP block in providing postoperative analgesia as a part of multimodal analgesia has been demonstrated in number of surgeries including colonic resection surgery, caesarean delivery, radical prostatectomy and also hysterectomy. In literature search investigators did not find any clinical study that has been carried out to see the effect of TAP block on stress response after hysterectomy. This study is designed to test the hypothesis that the TAP block, as part of a multimodal analgesic regimen, would attenuate stress response after TAH when compared with placebo. The investigators will also see any difference in postoperative pain and rescue analgesic demands and side effects among patients.
Rationale for the study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Patients will be randomly allocated in equal groups of 25 each to undergo TAP block (T group) with 20ml of 0.25% bupivacaine per side or TAP block with 20 ml of normal saline on both sides, which will be the control group (C group). The allocation sequence will be generated by a random number table, and group allocation will be concealed in sealed, opaque envelopes, which will not be opened until patient consent will be obtained. The process of randomization and blinding will be done by the clinical trial unit and according to the group allocation; pre-formed sterile syringes will be dispensed by the clinical trial unit to anesthesiologist performing the TAP block. The anesthesiologist performing the TAP block, patients and staff providing postoperative care will be blinded to group assignment.
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients scheduled for elective TAH via Pfannenstiel abdominal wall incision under general anaesthesia
- •American Society of Anesthesiologists physical status I-II
排除标准
- •Patients will be excluded if there is patient refusal to participate in the study, history of relevant drug allergy, or medical therapies considered to result in tolerance to opioids, hysterectomy performed for malignancy or inability to use patient control analgesia (PCA) devise
研究组 & 干预措施
Group T (TAP Block with Bupivicaine)
Ultrasound guided TAP block will be performed in this group. Bupivicaine 0.25 % 20 ml will be administered in the block on either side.
干预措施: TAP Block with Bupivicaine (Procedure)
Group C (TAP Block with Placebo drug)
Ultrasound guided TAP block will be performed in this group. 0.9 % Saline 20 ml will be administered in the block on either side.
干预措施: TAP Block with Placebo drug (Procedure)
结局指标
主要结局
Serum Norepinephrine
时间窗: 12 hours after surgery
Serum norepinephrine levels in pg/ml
Serum Cortisol
时间窗: 12 hours after surgery
Serum cortisol measured in µg/dL
次要结局
- Pain Score(12 hours after surgery)
- Side effects(12 hours after surgery)
- Rescue analgesia(12 hours after surgery)
- Total amount of opioid consumption(12 hours after surgery)
研究者
Samina Ismail
Professor
Aga Khan University