An interventional study of Ultrasound guided erector spinae plane block and Standard Pain Followup and Monitorization in Postoperative Pain, sponsored by Maltepe University. Completed at 1 site in Turkey. Open to male participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-29.
Sponsored by Maltepe University · Not applicable, Interventional, and Treatment
This study will define the postoperative analgesic effect of ESP block via amount of patient-controlled analgesia (PCA) and postoperative analgesic consumption (such as routinely and rescue analgesics) and compare the control group patients with retropubic radical prostatectomy .
Open retropubic prostatectomy is a surgical method that is applied in cases of benign prostatic hypertrophy and prostate cancer which is not suitable for surgical treatment with closed method. This method is commonly used among urological procedures which are open surgical procedures. Patients after this procedure often complain of excessive pain. Non-steroidal anti-inflammatory agents and opioids are used for postoperative analgesia. In addition, in the past decade, in the guideline of ultrasonography, peripheral block types have been described that demonstrate analgesic activity in open prostatectomies as well as many operations on the development of regional anesthesia and analgesia techniques. The ultrasonography guideline reported that the transverse abdominal plane (TAP) block provides effective analgesia in these cases. The ESP block is a new block for the treatment of thoracic neuropathic pain. In the following process; ESP block thoracic and breast surgery, bariatric surgery, and upper abdominal surgeons have also been reported to provide effective postoperative analgesia.
The standard practice for post-operative pain management for retropubic radical prostatectomy in Maltepe University Hospital consists of routine intravenous analgesic and rescue analgesics and in combination with patient-controlled analgesia (PCA).
The application of erector spinae plane (ESP) block technique under ultrasonography guideline under sedoanalgesia in patients who will undergo retropubic prostatectomy with open method should determine the effect on the patient's pain level in the first 24 hours after operation.
Elective retropubic radikal prostatectomy, ASA status 1-2
Exclusion Criteria:
Peroperative and postoperative routine analgesic protocol will be performed (consist of intravenous analgesics and intravenous patient controlled analgesia) with no additional intervention (block) Standard Pain Followup and Monitorization will be performed. Intervention: Other: Standard Pain Followup and Monitorization
Other: Standard Pain Followup and Monitorization
In addition to routine analgesic protocol; before anaesthesia induction; bilateral ultrasound guided erector spinae plane block (ESP) (intervention) will be performed via USG guidance at Th9 level.Standard Pain Followup and Monitorization will be performed. Interventions: Procedure: Ultrasound guided erector spinae plane block Other: Standard Pain Followup and Monitorization
Drug: Ultrasound guided erector spinae plane block · Other: Standard Pain Followup and Monitorization
A high-frequency linear ultrasound transducer will be placed in a longitudinal parasagittal orientation 3 cm lateral to T9 spinous process. The erector spinae muscles will be identified superficial to the tip of T9 transverse process. The patient's skin will be anesthetized with 2% lidocaine. A 17-gauge 8-cm needle will be inserted using an in-plane superior-to-inferior approach to place the tip into the fascial plane on the deep (anterior) aspect of erector spinae muscle. The location of the needle tip will be confirmed by visible fluid spread lifting erector spinae muscle off the bony shadow of the transverse process. A total of 30 mL of 0.375% bupivacaine will be injected (maximum of 3mg/kg).
Numeric Rating Scale (NRS) pain score will be recorded from 20th minute in recovery room followed by 1.-3.-6.-12.-18.-24.hours. Intravenous meperidine administration at 0.5 mg / kg rescue analgesia was determined in patients with a NSR score of 6 and over in the postoperative collection room. It is planned that the patient will continue to follow the hourly NRS score in ward. Intramuscular diclofenac will be administered in this period if NRS 6 and if it is over, intravenous 0.5 mg / kg meperidine will be administered if NRS score is 6 or more after 2 hours. Salvage analgesic needs and times will be noted in detail, and the use of rescue analgesics, as well as NRS scores at designated hours, will be kept in a statistical evaluation.
Changes in Numeric Rating Scale (NRS)
Changes in Numeric Rating Scale (NRS) at rest and on movement will be recorded at intervals. NRS is a unidimensional measure of pain intensity in adults. The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
Time frame: 24 hours
analgesic consumption
Tramadol consumption in Patient Controlled Analgesia device and additional and rescue analgesic using
Time frame: 24 hours
Plan to share: No — Data will not be shared
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Maltepe University