Comparison Of Erector Spinae Plane Block With Transversus Abdominis Plane Block For Postoperative Pain Management In Patients Undergoing Total Abdominal Hysterectomy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 44
- 主要终点
- Time of first rescue analgesia within 24hours
研究概览
简要总结
Hysterectomy is the second most common major Obstetric/gynecology procedure worldwide and one of the most common procedures in our institute. Post-operative pain is one of the most common complications following hysterectomy. Patients report moderate to severe pain following hysterectomy. Transversus abdominis plane block(TAP) is an established technique for abdominal and pelvic analgesia. Although efficient as an analgesic technique, it lacks visceral analgesia.Erector spinae plane block (ESP) is one of the newer developed regional techniques. Initially developed for Thoracic Neuropathic Pain by Forero et al, its use has expanded to include thoracic, abdominal and even femoral and below knee operative pain management.
Objective:
The objective of this study is to compare the ESP block with the TAP block for postoperative pain management in cases undergoing Total abdominal hysterectomy.
Methods:
A hospital based randomized, prospective, interventional study will be performed on all consenting patients undergoing total abdominal hysterectomy under general anesthesia. The required number of participants will be selected by probability sampling.
Fourty four female participants posted for elective Total abdominal hysterectomy under general anesthesia will be randomized onto two groups. The process of randomisation will be via computer generated randomization sequence.Each of the group will receive either of the two intervention after the completion of operative procedure. The post operative anelgesia duration and NRS score will be compared between the two groups.
Approval will be taken from the Institutional Review Committee (IRC) of Institute of Medicine.
Written consent will be taken prior to the data collection. Data will be entered in Microsoft Excel and errors will be checked. The clean data will be transferred into SPSS v 20 for analysis The results will be presented in terms of frequency percentage and table The associations will be established.
详细描述
Background
Hysterectomy is the second most common major Obstetric/gynecology procedure worldwide and one of the most common surgical procedure in our institute. Multiple indications like symptomatic uterine leiomyomas, abnormal uterine bleeding, endometriosis, and prolapse exist to warrant hysterectomy in a woman. By the age of 60, 1 in every 3 women in the US undergoes hysterectomy.
Multiple approaches and multiple techniques of hysterectomy exist.Approaches can be abdominal with pfannenstiel or low midline and Vaginal with paracervical incision. Techniques can be open, laparoscopic and even robot-assisted. The common approach in our resource limited setup is open abdominal with pfannenstiel incision.
Effective pain management plays a crucial role in reducing discomfort, aids in earlier mobilization, shortens hospital stay, reduces hospital cost, and increases patient satisfaction. The pain following hysterectomy is of moderate to severe grade. Many factors can influence post hysterectomy pain. Pre operative pain, extent of incision, approach to surgery, intra op and post operative pain management, age, socioeconomic status, presence of other painful sites all are risk factors for post hysterectomy pain. Adequate pain management is vital not only for patient comfort but also aids in early mobilization, improves functions, reduces venous thromboembolism risk and accelerates discharge. Furthermore in a Danish study by Birgitte Brandsborg using Danish Hysterectomy Database, the arthur noted the development of chronic Postoperative pain in 32% of all patients undergoing the procedure. One of the risk factors in the study was inadequate management of pain during preoperative and intraoperative periods.
Studies have shown pain perception in females to be higher than male population. Despite this women receive less pain management than men. Study by Esther H Chen et al on pain abdomen patients in the emergency department showed how women were less likely to get opioid analgesia, and had to wait longer to get analgesia to receive their dosing. All of these factors can play a significant role in increased pain and incidence of chronic pain in females.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All cases undergoing total abdominal hysterectomy under GA
- •Age >18 years
- •Elective cases
- •ASA PS I & II
排除标准
- •Patient refusal
- •Patient with contraindication to peripheral Nerve blocks
- •Allergy to local anesthetics
- •Weight less than 50kg
结局指标
主要结局
Time of first rescue analgesia within 24hours
时间窗: 24hours
Rescue analgesia used injection Tramadol, given if Numerical rating score(NRS) \>3 withing 24hours of the procedure.
次要结局
- Comparision of side effect: Incidence of Respiratory depression,Incidence of sedation, motor block, postoperative nausea and vomiting postoperative nausea and vomiting of intervention(24hours)
- Pain assessment at set time(24hours)
- Total amount of rescue analgesia.(24hours)
研究者
Dr Biplov Neupane
Resident, Department of Anesthesiology, Tribhuvan University Teaching Hospital, Institute Of Medicine.
Tribhuvan University Teaching Hospital, Institute Of Medicine.