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This clinical trial aims to evaluate the effectiveness of the ultrasound-guided erector spinae plane (ESP) block in managing postoperative pain for patients undergoing open nephrectomy (kidney removal surgery). The study will compare this new technique to traditional pain management methods, such as opioid medications, to assess whether the ESP block reduces pain and the need for opioids after surgery.
Patients will be randomly assigned to one of two groups:
Group C will receive conventional pain relief methods, including opioids. Group E will receive the ultrasound-guided ESP block in addition to general anesthesia.
The main goals are to determine:
How much pain relief each method provides, measured using a visual analog scale (VAS).
The total amount of opioids required during the first 24 hours post-surgery.
Additional measurements will include monitoring vital signs like heart rate, blood pressure, and oxygen levels.
This study will help find safer and more effective ways to manage pain after nephrectomy, reducing the reliance on opioids and improving patient recovery
This randomized controlled trial aims to assess the efficacy of ultrasound-guided erector spinae plane (ESP) block in managing postoperative pain in patients undergoing open nephrectomy. Nephrectomy, a common procedure for kidney removal, often results in severe postoperative pain, which can contribute to complications such as postoperative pulmonary complications (PPC) and delayed recovery. Traditional analgesic techniques, including systemic opioids and epidural analgesia, have various side effects such as nausea, vomiting, constipation, and respiratory depression. Additionally, opioids may lead to tolerance, especially in cancer patients. Erector spinae plane block (ESP) is a newer regional technique that has gained attention due to its potential to provide effective analgesia with minimal side effects.
This study will evaluate whether the ESP block can provide better pain control and reduce opioid consumption compared to conventional pain management techniques. The ESP block targets the erector spinae muscle and provides analgesia via fascial plane blocks, which is believed to be effective in controlling visceral and somatic pain, typically associated with nephrectomy.
The trial will involve 66 adult patients scheduled for open nephrectomy under general anesthesia. Patients will be randomly assigned to one of two groups:
Control Group (Group C): Patients will receive conventional analgesia, including opioids and standard local anesthetic techniques.
Intervention Group (Group E): Patients will receive general anesthesia combined with the ultrasound-guided ESP block, administered immediately before anesthesia induction.
The primary outcome of the trial is to measure the first postoperative opioid requirement, utilizing the Visual Analogue Scale (VAS) for pain assessment. Secondary outcomes include the total opioid consumption in the first 24 hours, the intensity of postoperative pain at various time points, and the hemodynamic responses (heart rate, blood pressure). Additionally, peak expiratory flow rate (PEFR) will be monitored to assess respiratory function as part of the recovery process.
By evaluating these outcomes, the study aims to provide insights into whether ESP block can serve as a safer, effective alternative to traditional analgesia, improving postoperative pain management and reducing the risks associated with opioid use. The results may guide clinical practice in nephrectomy pain management, offering a potential improvement in patient recovery times and satisfaction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group: Conventional Pain Management | No Intervention | This group will receive general anesthesia along with conventional pain management techniques, including opioid analgesics and other standard interventions typically used in postoperative nephrectomy care | |
| Intervention Group: Ultrasound-Guided Erector Spinae Plane Block | Experimental | Patients in this group will receive general anesthesia in combination with the ultrasound-guided erector spinae plane (ESP) block, administered before the induction of anesthesia. The block targets the erector spinae muscle fascial plane, aiming to reduce postoperative pain and opioid consumption. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound-Guided Erector Spinae Plane (ESP) Block | Procedure | The Ultrasound-Guided Erector Spinae Plane (ESP) Block is a regional anesthesia technique used to provide postoperative pain relief. In this study, the intervention involves the administration of a local anesthetic (0.25% bupivacaine) into the fascial plane between the erector spinae muscle and the transverse process of the vertebra using ultrasound guidance. The procedure is performed immediately before the induction of general anesthesia in patients undergoing open nephrectomy. The goal of the ESP block is to reduce postoperative pain, minimize opioid consumption, and improve recovery outcomes while maintaining hemodynamic stability. This intervention is compared to conventional pain management methods, which primarily rely on systemic opioids and other standard analgesics. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale (VAS) for pain | VAS score measures the intensity of pain, with 0 indicating no pain and 10 indicating the worst possible pain. A lower VAS score means less pain and better pain management. A higher VAS score means more pain and poorer pain control. | VAS score will be The VAS score will be recorded within the first 24 hours after surgery upon the patient's arrival in recovery, at 1, 3, 6,12 and 24 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Opioid Consumption | Total opioid consumption will be tracked and recorded for each group during the first 24 hours post-surgery. The total amount of opioids used (in milligrams) will serve as an indicator of pain control effectiveness. A reduction in opioid consumption in the ESP block group, compared to the control group, would suggest that the ESP block is effective in reducing the need for opioids, thereby minimizing opioid-related side effects. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kazi Mahzabin Arin, MD | Contact | +8801754057689 | kazimahzabinarin@bsmmu.edu.bd | |
| AKM Akhtaruzzaman, MD | Contact | +8801819220195 | akm.akhtaruzzaman@bmu.ac.bd |
| Name | Affiliation | Role |
|---|---|---|
| AKM Akhtaruzzaman, MD | Bangladesh Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bangladesh Medical University | Recruiting | Dhaka | 1000 | Bangladesh |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39308995 | Background | Yang JH, Sun Y, Yang YR, Qi LN, Li WY, Qin XZ. The Analgesic Mechanism and Recent Clinical Application of Erector Spinae Plane Block: A Narrative Review. J Pain Res. 2024 Sep 17;17:3047-3062. doi: 10.2147/JPR.S468560. eCollection 2024. | |
| 34430749 | Background | Yetneberk T, Chekol B, Teshome D. The efficacy of TAP block versus ilioinguinal block for post-cesarean section pain management: A systematic review and meta-analysis. Heliyon. 2021 Aug 13;7(8):e07774. doi: 10.1016/j.heliyon.2021.e07774. eCollection 2021 Aug. |
| Label | URL |
|---|---|
| Related Info | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| pain.medicine@bsmmu.edu.bd | Study Protocol | View IPD |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D010268 | Parapsychology |
| D003766 | Dental Occlusion |
| ID | Term |
|---|---|
| D001525 | Behavioral Sciences |
| D004191 | Behavioral Disciplines and Activities |
| D003813 | Dentistry |
| D009063 | Dental Physiological Phenomena |
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| Total opioid consumption will be calculated and recorded in mg within the first 24 hours postoperatively. |
| Peak Expiratory Flow Rate (PEFR) | PEFR will be measured preoperatively and at multiple points postoperatively (1, 3, 6, and 24 hours) to assess respiratory function. This is particularly important in nephrectomy patients, as effective pain management helps promote better respiratory outcomes and reduce the risk of atelectasis or other complications. A higher PEFR value suggests better lung function and recovery. | PEFR values will be assessed preoperatively and at arrival to 1, 3, 6, and 24 hours postoperatively. |
| Heart Rate (HR) Monitoring | Heart rate (HR) will be monitored preoperatively and at regular intervals postoperatively (0, 1, 3, 6, 12, 24 hours). This will help assess whether the ESP block maintains hemodynamic stability without causing significant fluctuations, such as tachycardia (increased heart rate), compared to conventional analgesia methods. | Heart rate (HR) will be measured preoperatively and at 0, 1, 3, 6, 12, and 24 hours postoperatively. |
| Systolic Blood Pressure (SBP) Monitoring in mmHg | Systolic blood pressure (SBP) will be recorded preoperatively and at regular intervals (0, 1, 3, 6, 12, and 24 hours) postoperatively. The aim is to evaluate whether the ESP block offers better hemodynamic control by preventing significant blood pressure fluctuations compared to conventional analgesia methods. | Systolic blood pressure (SBP) will be measured preoperatively and at 0, 1, 3, 6, 12, and 24 hours postoperatively. |
| Diastolic Blood Pressure (DBP) Monitoring in mmHg | Diastolic blood pressure (DBP) will be measured preoperatively and at regular intervals postoperatively (0, 1, 3, 6, 12, 24 hours). Monitoring DBP helps assess the stability of the cardiovascular system and ensure that the ESP block does not lead to significant hypotension or other adverse effects on circulation. | Diastolic blood pressure (DBP) will be measured preoperatively and at 0, 1, 3, 6, 12, and 24 hours postoperatively. |
| Mean Arterial Pressure (MAP) Monitoring in mmHg | Mean arterial pressure (MAP) will be monitored preoperatively and at regular intervals postoperatively (0, 1, 3, 6, 12, 24 hours). MAP is a key indicator of perfusion pressure, ensuring adequate blood flow to organs. This outcome will evaluate whether the ESP block maintains stable MAP levels compared to conventional analgesic methods. | Mean arterial pressure (MAP) will be measured preoperatively and at 0, 1, 3, 6, 12, and 24 hours postoperatively. |
| 35345697 | Background | Unal S, Baskan S, Guven Aytac B, Aytac I, Balci M. Should the Erector Spinae Plane Block Be Applied in the Pain Management of Percutaneous Nephrolithotomy? Cureus. 2022 Feb 24;14(2):e22554. doi: 10.7759/cureus.22554. eCollection 2022 Feb. |
| 33716419 | Background | Rizkalla JM, Holderread B, Awad M, Botros A, Syed IY. The erector spinae plane block for analgesia after lumbar spine surgery: A systematic review. J Orthop. 2021 Feb 18;24:145-150. doi: 10.1016/j.jor.2021.02.006. eCollection 2021 Mar-Apr. |
| 39196544 | Background | Rose TL, Kim WY. Renal Cell Carcinoma: A Review. JAMA. 2024 Sep 24;332(12):1001-1010. doi: 10.1001/jama.2024.12848. |
| 35193139 | Background | Ni Y, Yang X. A Systematic Review and Meta-Analysis of Comparison of Outcomes of Robot-Assisted versus Open Partial Nephrectomy in Clinical T1 Renal Cell Carcinoma Patients. Urol Int. 2022;106(8):757-767. doi: 10.1159/000521881. Epub 2022 Feb 22. |
| 35852550 | Background | Lavand'homme PM, Kehlet H, Rawal N, Joshi GP; PROSPECT Working Group of the European Society of Regional Anaesthesia and Pain Therapy (ESRA). Pain management after total knee arthroplasty: PROcedure SPEcific Postoperative Pain ManagemenT recommendations. Eur J Anaesthesiol. 2022 Sep 1;39(9):743-757. doi: 10.1097/EJA.0000000000001691. Epub 2022 Jul 20. |
| 22250276 | Background | Aubrun F, Mazoit JX, Riou B. Postoperative intravenous morphine titration. Br J Anaesth. 2012 Feb;108(2):193-201. doi: 10.1093/bja/aer458. |
| 39574036 | Background | Amr SA, Othman AH, Ahmed EH, Naeem RG, Kamal SM. Comparison between ultrasound guided erector spinae plane block and paravertebral block on acute and chronic post mastectomy pain after modified radical mastectomy: randomized controlled trial. BMC Anesthesiol. 2024 Nov 21;24(1):420. doi: 10.1186/s12871-024-02810-4. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D055688 | Digestive System and Oral Physiological Phenomena |