Effects of Pain Management Protocol on Patient's Undergoing Abdominal Surgeries in Erbil City Hospitals
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Average Postoperative Pain Intensity (VAS)
研究概览
简要总结
Intervention Our study involves a novel multimodal pain management protocol for postoperative pain management. The protocol consists of 4 main phases: preoperative, intraoperative, postoperative, and post-discharge phases with different pain management strategies. Each phase is designed to work synergistically with the subsequent phases to optimize pain control and minimize opioid use. All interventions will be administered by trained healthcare professionals and will be tailored to individual patient needs and responses. The protocol will be continuously monitored and adjusted as necessary to ensure optimal pain management while minimizing potential side effects and opioid use.
Preoperative phase The preoperative phase focuses on patient education with the aim of educating patients on pain expectations, management strategies, and the recovery process. This is exclusively comprised of educational sessions delivered to each included patient. The sessions are designed to interactively explain the surgical procedure, expected pain levels, and available pain management options using multimedia resources such as videos and brochures. Well-trained pain management specialists will conduct the sessions, and pre-post quizzes will be carried out to ensure optimal patient understanding. Additionally, during this phase, patients will be educated on how to report their perceived pain, rated from 0 to 10 on the visual analog scale (VAS). Subsequently, another dedicated pain-management specialist will engage with each patient to formulate and document an individualized pain management plan, taking into consideration the patient's medical history, previous pain experiences, and preferences for pain management strategies. As part of preemptive analgesia, patients receive 300 mg of gabapentin orally 2 hours prior to surgery, unless contraindicated.
4.2. Intraoperative phase At this phase, our main objective is to utilize effective anesthetic strategies that minimize postoperative pain and accelerate recovery. We will utilize the current standardized protocol, including premedication with midazolam (0.02-0.04 mg/kg IV), induction with propofol (1.5-2.5 mg/kg IV), and maintenance of anesthesia using isoflurane or sevoflurane (0.5-1.5 MAC). When appropriate, patients will also receive ultrasound-guided regional nerve blocks relevant to the surgical site, performed by a trained anesthesiologist, to enhance postoperative pain control.
4.3. Postoperative management Postoperatively, our multimodal management plan aims to maximize pain management, minimize opioid use, and enhance patient recovery. This phase includes complementary both non-pharmacologic and pharmacologic interventions. In particular, non-pharmacologic measures will include physical therapy, cognitive behavioral therapy (CBT), and transcutaneous electrical nerve stimulation (TENS). Pharmacologic intervention in this phase will include optimized use of NSAIDs, tramadol, adjuvant analgesics, and skeletal muscle relaxants in patient-centered, tailored plans that minimize opioid consumption.
For the non-pharmacologic part, early mobilization and physical therapy will start on postoperative day 1, with patients engaging in physical activities supervised by a physical therapist. This step will focus on promoting circulation, maintaining muscle strength, and gradually increasing mobility. CBT sessions, conducted by a trained psychologist, will be offered to patients either individually or in groups. These sessions will concentrate on developing pain-coping strategies and stress-reduction techniques. Additionally, transcutaneous electrical nerve stimulation (TENS) units will be made available for patient use as needed, with proper instruction on application and usage provided by nursing staff.
详细描述
The pharmacological regimen includes non-opioid analgesics as the foundation of pain control. Patients will receive either ibuprofen 400 mg PO q6h or diclofenac 50 mg PO q8h for the first 48 hours postoperatively, unless contraindicated. This will be complemented by acetaminophen 1,000 mg PO q6h, not exceeding 4,000 mg/day. For breakthrough pain, tramadol 50-100 mg PO q6h is administered on an as-needed basis, with its use limited to the shortest duration necessary to manage acute pain. Adjuvant medications include gabapentin, continued at 100-300 mg PO TID and titrated based on patient response and tolerability, and cyclobenzaprine 5 mg PO TID as needed for muscle spasms.
Discharge phase This phase is designed to investigate the impact of the continuity of care provided from the previous phases and monitor progress following discharge. Prior to discharge, we will set a training session for each patient to illustrate the proper use of pharmacologic and non-pharmacological interventions at home. Furthermore, we will conduct a phone call 48 hours post-discharge to assess pain control and overall recovery and address any concerns or complications that may have arisen.
Randomization Eligible patients will be randomly assigned to the intervention group and control group in a 1:1 allocation ratio using computer-assisted random number generation. To account for the multicenter design, stratified randomization will be adopted based on hospitals. Permuted block sequences with variable block sizes of 2,4,6 were implemented to ensure random allocation to the study arms. The randomization list and randomization cards were produced [see Appendix 3] and will be kept in sealed, opaque envelopes to ensure allocation concealment. These envelopes will be opened by the treating physician only after patient eligibility is confirmed and informed consent is obtained. The randomization process was processed using "blockrand" package in R.
Outcomes:
The primary outcome of the current study will be the change in pain intensity assessed using a visual analog scale (VAS) comprised of 11 points, where zero represents no pain, and 10 represents the worst imaginable pain. The assessment of NRS will be conducted at 2, 6, 12, 24, 48, and 72 hours postoperatively. Based on the individual NRS scores vs. time profile, the area under the curve over the time frame of 72 will be calculated for each patient.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years.
- •Scheduled for elective abdominal surgery (including but not limited to cholecystectomy, appendectomy, hernia repair, and bowel resection).
- •American Society of Anesthesiologists (ASA) physical status classification I-III
- •Able to provide written informed consent.
- •Capable of understanding and complying with the study protocol, including pain assessments and follow-up requirements.
排除标准
- •Emergency or urgent abdominal surgeries
- •Chronic pain conditions requiring daily opioid use (>30 morphine milligram equivalents per day) for ≥3 months prior to surgery
- •History of substance abuse disorder within the past 5 years
- •Severe hepatic impairment (Child-Pugh class C) or renal dysfunction (estimated glomerular filtration rate <30 mL/min/1.73m²)
- •Allergies or contraindications to any component of the multimodal pain management protocol
- •Cognitive impairment preventing reliable self-reporting of pain scores
- •Pregnancy or breastfeeding
研究组 & 干预措施
Standardized Multimodal Pain Management Protocol Arm
During the preoperative phase, patients attend one-on-one educational sessions led by pain management specialists. Using videos and brochures, they learn about the surgery, expected pain levels, and both pharmacologic and nonpharmacologic management options. Pre- and post-session quizzes check comprehension and ensure patients can report pain using the visual analog scale (VAS) from 0 to 10. Then, a second specialist develops and documents a personalized pain management plan considering medical history, past pain experiences, and preferences. As preemptive analgesia, patients receive 300 mg oral gabapentin two hours before surgery, if not contraindicated. Brief discussion of sensory and emotional aspects of pain also prepares patients psychologically. Detailed documentation in the record promotes continuity of care. This combined approach aims to improve postoperative pain control, decrease opioid use, facilitate early mobilization, and enhance patient satisfaction. Enhanced outcomes.
干预措施: Gabapentin (Neurontin® (Registered Trademark)) (Drug)
结局指标
主要结局
Average Postoperative Pain Intensity (VAS)
时间窗: Up to 48 hours postoperatively (with VAS assessments at 4, 8, 12, 24, and 48 hours)
Postoperative pain intensity is measured using a 10-cm Visual Analog Scale (VAS) from 0 (no pain) to 10 (worst pain). Assessments occur at rest and during movement at 4, 8, 12, 24, and 48 hours postoperative. Nursing staff blinded to group allocation record VAS scores on standardized forms. The primary outcome is the mean of all patient-reported VAS scores during the first 48 hours. Highest and lowest scores are noted, and analgesic administration type and timing are documented. Before each assessment, patients are instructed on marking current pain. Interrater reliability is reinforced through periodic calibration sessions. If a patient cannot self-report, an observational pain scale is recorded but excluded from the primary outcome. Missing VAS data are imputed via last observation carried forward. All data are entered into a secure database. The mean pain intensity for each patient is compared between protocol and control arms to determine protocol effectiveness. Quality checks don
次要结局
未报告次要终点
研究者
Haroon Muhammad Khalil
Effects of Pain Management Protocol on Patient's Undergoing Abdominal Surgeries in Erbil City Hospitals
Hawler Medical University