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IRCT20230822059225N1 IRCT 2023-08-26 CMH Gujranwala ESP VERSUS INTERCOSTAL NERVE BLOCK FOR PAIN IN RIB FRACTURES INTERCOSTAL NERVE BLOCK (INB) VERSUS ERECTOR SPINAE BLOCK (ESP) FOR ANALGESIC EFFICACY IN PATIENTS WITH TRAUMATIC MULTIPLE RIB FRACTURES 2023-04-01 anticipated 380 Complete https://irct.ir/trial/72215 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Minimum sample size came out to be 365 patients after using the WHO calculator keeping the confidence interval at 95%, margin of error at 5%. We included 380 patients in our study according to the inclusion criteria furnished. The method of randomization was non-probability consecutive after lottery method into Group E for ESP block and Group I for Intercostal nerve block intervention (190 patients in each group). Patients were randomly selected through lottery method by chits given to the resident on duty in the operating room and patients designated to each intervention were documented and recorded on an excel sheet for data record. 1-2 Rib fracture. Intervention 1: Intervention group: Group E: Erector spinae block group.Patients in Group E received intravenous 0.5% bupivacaine with 2% lignocaine diluted in distilled water to make a total volume of 20 ml given according to block guidelines under ultrasound guidance furnished by NYSORA. Intervention 2: Intervention group: Group I: Intercostal nerve block group.Patients in Group I received the similar titration of drug as 3 ml aliquots in each intercostal space under ultrasound guidance according to block guidelines furnished by NYSORA. Yes - There is a plan to make this available What will be shared: Article manuscript, data set and output SPSS sheets after approval of article by journal When: After approval of the manuscript by the journal, data will be available online indefinitely To whom: All academic institutions including residents and consultants for their academic purposes Conditions: For academic purposes Where to obtain: Through email after approval from the primary author Dr. Taimur Azam Afridi Email: taimurazamafridi@yahoo.com How to obtain: Request through email to be approved by primary author Email already provided Usual scrutiny time from contact through email to grant of permission is approximately 7 days Comments:
public Taimur Afridi
CMH Gujranwala
Gujranwala Pakistan 52250 +92 346 5051728 taimurazamafridi@yahoo.com Combined Military Hospital Gujranwala scientific Taimur Afridi
CMH Gujranwala
Gujranwala Pakistan 52250 +92 346 5051728 taimurazamafridi@yahoo.com Combined Military Hospital Gujranwala Pakistan Included all male and female patients between ages 25-55 years presenting in the operating room for pain relief with regional block with multiple rib fractures (>2 ribs) Not requiring surgical intervention for repair Under observation in the high dependency unit 25 years 55 years Both Patients with metastatic disease Major cardiac or respiratory disease, low ejection fraction or post chemotherapy Allergy to lignocaine or bupivacaine Patients with advanced polytrauma causing hemodynamic instability Patients with oxygen saturation less than 92% after supplemental oxygen Patients with flail chest or pneumothorax Patients unwilling to be included in the study S22.4 Multiple fractures of ribs Treatment - Drugs Treatment - Drugs Intervention group: Group E: Erector spinae block group.Patients in Group E received intravenous 0.5% bupivacaine with 2% lignocaine diluted in distilled water to make a total volume of 20 ml given according to block guidelines under ultrasound guidance furnished by NYSORA Intervention group: Group I: Intercostal nerve block group.Patients in Group I received the similar titration of drug as 3 ml aliquots in each intercostal space under ultrasound guidance according to block guidelines furnished by NYSORA Time to first dose of rescue analgesia. Timepoint: 24 hours after intervention. Method of measurement: Pain score above 5 on the standard visual analog scale. Total dose of analgesia given. Timepoint: In 24 hours after intervention. Method of measurement: Dose charting of intravenous nalbuphine once pain scores above 5 after intervention. Patient satisfaction. Timepoint: 24 hours after intervention. Method of measurement: Standard 7 point Likert scale. Nausea/Vomiting. Timepoint: In 24 hours after intervention. Method of measurement: Frequency of episodes by the resident anesthetist on duty in HDU. Hypotension. Timepoint: In 24 hours after intervention. Method of measurement: Systolic BP <80 and Diastolic <60 mmHg monitored and charted hourly. Post-procedure sedation. Timepoint: In 24 hours after intervention. Method of measurement: Digital sphygmomanometer. CMH Gujranwala Approved 2023-03-01 Ethical Review Board CMH Gujranwala Gujranwala Cantt Gujranwala Punjab Pakistan