Evaluation of Effectivity of Erector Spina Plane Block With Different Levels
- Conditions
- Postoperative Pain
- Interventions
- Procedure: T7 Level Erector Spinae Plane BlockProcedure: T9 Level Erector Spinae Plane BlockDrug: control group
- Registration Number
- NCT04316416
- Lead Sponsor
- Gaziosmanpasa Research and Education Hospital
- Brief Summary
In last years, erector spinae plane block is widely used in abdominal and thoracic surgeries. Laparoscopic cholecystectomy is one of the most commonly performed surgical operations. In this study, the investigators will evaluate the effectiveness of erector spina plan block with different injection levels for postoperative analgesia on patients undergoing laparoscopic cholecystectomy surgery.
- Detailed Description
Three groups were planned for this study.Randomization was planned with the closed envelope method. İn the first group, the ESP(erector spinae plane) block procedure will be applied from the T7 level bilaterally and in the second group it will be applied from the T9 level bilaterally. ESP block procedure will not be applied in the third group and this group will be considered as the control group. A comparison of NRS (Numeric Rating Scale) and morphine consumption will be planned for all groups of patients at 1-th, 4-th, 8-th.,12-th and,24-th postoperative hours.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 103
- ASA 1-2 Elective cholecystectomy surgery
- 18-65 years old patients
- ASA 3-4 patients
- Patient refusal
- several lung and heart disease
- Contraindications to regional anesthesia
- BMİ > 35 patients
- Known allergy to local anesthetics
- Bleeding diathesis
- Use of any anti-coagulants
- Severe kidney or liver disease
- Patient with psychiatric disorders
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description T7 Bilateral ESP block T7 Level Erector Spinae Plane Block Ultrasound-guided bilateral Erector spinae plane block will performe at end of the surgery with 40 ml of a bupivacaine/lidocaine mixture by imaging T7 (7th thoracal vertebrae ) transverse process accompanied by ultrasound. Postoperative routine analgesic protocol planned (consist of intravenous analgesics and intravenous patient-controlled analgesia) with no additional intervention (block). Standard pain follow-up and monitorization will be performed. T9 bilateral ESP block T9 Level Erector Spinae Plane Block Ultrasound-guided bilateral Erector spinae plane block will performe at end of the surgery with 40 ml of a bupivacaine/lidocaine mixture by imaging transverse process T9 (9th thoracal vertebrae) by ultrasound. Postoperative routine analgesic protocol planned (consist of intravenous analgesics and intravenous patient-controlled analgesia) with no additional intervention (block). Standard pain follow-up and monitorization will be performed. Control group control group Postoperative routine analgesic protocol will be performed (consist of intravenous analgesics and intravenous patient-controlled analgesia) with no additional intervention (block) Standard pain follow-up and monitorization will be performed. No block will be performed in this group.
- Primary Outcome Measures
Name Time Method Postoperative pain change up to 24 hours It was planned to check the change in the NRS scores of patients at 1.,4.,8.,12.,24 hours for evaluation of efficacy level and effect time of ESP block procedure from different levels.
A NRS involves asking the patient to rate his or her pain from 0 to 10 (11 point scale) with the understanding that 0 is equal to no pain and 10 is equal to worst possible pain.Postoperative morphine consumption change up to 24 hours It was planned to check the change in the morphine consumption of patients at 1.,4.,8.,12.,24 hours for evaluation of efficacy level and effect time of ESP block procedure from different levels.
- Secondary Outcome Measures
Name Time Method side effects up to 24 hours Rate of side-effect occurrences (such as rate of vomiting,nausea,shoulder pain) between groups will be compared.
number of blocked dermatome sites up to 24 hours number of blocked dermatome sites will be recorded.
Trial Locations
- Locations (1)
Gaziosmanpasa Research and Education Hospital
🇹🇷Istanbul, Turkey