Evaluating The Quality of Recovery After Elective Cesarean Section Using ObsQoR-10, A Comparative Study Between Two Modalities for Pain Control.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- ObsQor-10 score
研究概览
简要总结
Adequately validated patient-reported outcome measures are available, which can assess recovery profiles following childbirth. This study will explore the effect of two different methods for pain management on the quality of recovery of pregnant women undergoing cesarean section
详细描述
- Type of Study: RCT
- Study Setting: Obstetric theatre at Ain Shams University Hospital
- Study Period :6 months
As per routine hospital practice, the pre-anesthetic assessment is performed, two 18 G peripheral cannula are inserted and 1 mg of granisetron and 50 mg of ranitidine are administered intravenously (IV) as premedications one hour before the operation, and 10 mL/kg of Ringer's lactate solution was infused for 15 minutes as a preload. All the study participants received a standard spinal anesthetic consisting of 10-12 mg of 0.5% hyperbaric bupivacaine.
The patients will be monitored using electrocardiography, non-invasive blood pressure measurement and pulse oximetry (SpO2). Spinal injection will be performed under aseptic technique in the sitting position at L3-L4 or L4-L5 intervertebral space using a 27-G Quincke needle.
The patients will be laid down in a supine position and oxygen therapy will be initiated at a rate of 6 L/min via a facemask throughout the procedure.
The level of sensory block will be confirmed using sensation to cold, the accepted level for initiation of the surgery will be at T4-5level.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •American Society of Anesthesiologists physical status classification ΙΙ; and scheduled for elective cesarean section using a low transverse Pfannenstiel incision with spinal anesthesia.
排除标准
- •(1) major hepatic, renal, or cardiovascular disease; (2) local infection; (3) bleeding disorder; (4) any contraindication for spinal anesthesia; or (5) known allergy to any drug used in the study (6) refusal to participate in the study (7) BMI > 35 (8) had opioid dependence (9) chronic analgesic usage (10) inability to use patient controlled analgesia (PCA) device.
研究组 & 干预措施
PCA group
: the PCA pump will be connected in a separate cannula. The pump contains 0.5 mg nalbuphine/ ml. the basal rate is 5ml/h and lock out time is 10 min.
干预措施: PCA (Drug)
QL block group
. Patients will receive bilateral ultrasonography (USG) guided block with 20 ml of 0.25 % bupivacaine on each side. The block is performed by anaesthesia consultants having experience of 5 years in ultrasound guided blocks. The procedure will be performed using aseptic technique (gown, gloves, facemask and protective sheath for the ultrasound probe).
The curvilinear probe (2 5 MHz, SonoSite Turbo M) is placed in the transverse axial plane just cranial to the iliac crest. The "shamrock sign" was visualised (viz., the transverse process (TP) of vertebra L4 is the stem, whereas the erector spinae muscle (ESM) posteriorly, quadratus lumborum (QL) muscle laterally and the psoas major (PM) muscle anteriorly represent the three leaves). The needle is introduced using an in plane technique from the posterior end of the transducer through the QL muscle. The target for injection is the fascial plane between the QL and PM muscles.
干预措施: QL block (Procedure)
结局指标
主要结局
ObsQor-10 score
时间窗: 24 hours postoperative
compare the total ObsQor-10 score in both groups to determine which pain management intervention yields a better outcome.
次要结局
- validation of ObsQoR-10(24 hours)
研究者
Adham Haggag
Associate proffesor
Ain Shams University