Effects of Ultrasonography-Guided Plan Blocks (ESP&OSTAP) on Perioperative Analgesia in Laparoscopic Hysterectomies
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 120
- Locations
- 4
- Primary Endpoint
- Plane blocks
Study Overview
Brief Summary
Hysterectomy is the most common major intervention in gynecology after cesarean section. Indications include myoma uteri, abnormal uterine bleeding, cervical intraepithelial neoplasia, chronic pelvic pain, uterine uteri, operated breast cancer, and endometrial hyperplasia. Today, hysterectomy can be performed abdominally, vaginally and laparoscopically.¹ Laparoscopic hysterectomy (LH) has several advantages and disadvantages compared to other forms of hysterectomy. Shorter recovery time, less wound infection, shorter hospital stay, and less need for postoperative analgesia can be counted among the advantages. The prolongation of the operation time and the increased risk of urinary complications are disadvantages.² Postoperative pain management can be done with different methods depending on the location of the surgical field, the type of surgical procedure, the patient's need for analgesia, and patient preference. These methods include oral, intravenous or intramuscular medication and nerve blocks. In order to minimize the side effects of opioids used in analgesic therapy such as respiratory depression, nausea-vomiting, lethargy, constipation and itching, and to increase the analgesic effect, the "balanced analgesia" method is used.⁴ With this method, opioids, non-opioid analgesics or peripheral nerve-field blocks side effects are minimized and optimum analgesia is provided.
Transversus abdominis plane (TAP) block, which is one of the abdominal field blocks, was first described by Rafi in 2001.⁶ Hebbard et al. stated in 2007 that ultrasonography (USG)-guided TAP block can be applied more effectively and safely.⁷ This block can be applied more effectively and safely.⁷ This block is antero-lateral, posterior, and oblique It can be done subcostal with three different approaches. TAP block has been shown to reduce postoperative pain after hysterectomy, cesarean section, and colorectal surgery.⁸ Erector spina plane (ESP) block was first described by Forero et al. in 2016 on a patient with chronic neuropathic pain.⁹ The basic technique is performed paraspinally under USG guidance. It is used for postoperative analgesia in breast, thoracic surgeries, hernia repair, dorsal colon, abdomen and hip surgery.
In this study, it is aimed to compare the effects of USG-guided ESP block and OSTAP block applications on perioperative pain control in total laparoscopic hysterectomy operations.
Detailed Description
MATERIAL AND METHOD Patients between the ages of 18-65, ASA I-II, BMI ≤30 kg/m2 who will undergo elective surgery under general anesthesia, with voluntary consent will be included in the study. Patients with local anesthetic allergy, coagulopathy, infection at the block application site, and mental deficiency and for whom the surgical plan has been changed (complicated/open surgery) will be excluded from the study.
Patients included in the study will be informed about patient-controlled analgesia (PCA) and numerical rating scale (NRS: Numeric Rating Scale) for the assessment of pain severity before the operation. Demographic data of the patients will be recorded.
Anesthesia Application:
After the intravenous (IV) route is provided with a 20 G cannula in the preoperative preparation room, 10 mL/kg of balanced crystalloid fluid infusion will be started. 0.03 mg/kg midazolam will be administered for premedication. Standard monitoring (ECG, heart rate, non-invasive blood pressure, SPO2, temperature) and neuromuscular monitoring will be applied to all patients. The input value of these parameters will be saved before induction. Records will be taken at 5-minute intervals until the end of the operation. For induction of anesthesia, 2 mg/kg propofol, 1μg/kg remifentanil will be administered as an IV bolus within 60 seconds. Analgesia maintenance will be provided with 0.05-0.25 μg/kg/min remifentanil infusion. Muscle relaxation will be provided with IV 0.6 mg/kg rocuronium. He will be intubated orotracheally when his train of four rate (TOFR) response is zero. (In case of neuromuscular blocker requirement, IV 0.01 mg/kg rocuronium will be additionally administered.) Anesthesia is maintained with 0.5 L/min fresh gas flow, oxygen concentration with inspiratory oxygen level between 40-45, minimum alveolar concentration (MAC) with 0.9-1.1 with sevoflurane. will be applied. Mechanical ventilation will be performed with Volume AutoFlow mod (V-AF) with ETCO2 between 35-40 mmHg.
Patients will be randomly divided into two groups after induction. Group ESP (I): The group to which Erector Spina Plan Block (ESP) will be administered Group OSTAP (II): The group to which Oblique Subcostal Transversus Abdominis Plan Block (OSTAP) will be applied In the study, anesthesia induction and plan blocks will be performed by the same anesthesiologist. Intraoperative and postoperative data recording and patient evaluation will be done by two separate anesthesiologists.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Between 18-65 years laparoscopic hysterectomy under general anesthesia ASA I-II BMI ≤30 kg/m2
Exclusion Criteria
- •local anesthetic allergy coagulopathy infection at the block application site mental deficiency the surgical plan has been changed (complicated/open surgery)
Outcomes
Primary Outcomes
Plane blocks
Time Frame: Intraoperative and postoperative first 24 hours
Analgesic efficacy between ESP and OSTAP blocks will be evaluated by Numeric Rating Scale. Intraoperative and postoperative opioid consumption will be compared.
Secondary Outcomes
- Nausea(Intraoperative and postoperative first 24 hours)
Investigators
Nazan KOCAOGLU, MD
Assistant professor
Balikesir University