Ignite Creation Date:
2024-05-06 @ 4:07 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04872192
Status:
COMPLETED
Last Update Posted:
2021-10-11
First Post:
2021-05-02
Brief Title:
Analgesic Efficacy of Transversus Thoracic Muscle Plane Block on Post-sternotomy Pain
Sponsor:
Ain Shams University
Organization:
Ain Shams University
Study Overview
Official Title:
Evaluation of the Analgesic Efficacy of Bilateral Ultrasound-guided Transversus Thoracic Muscle Plane Block on Post-sternotomy Pain a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients were randomly allocated to either Tansversus group T group and general anesthesia N groupPatient demographic data preoperative medical status left ventricular function and operative data total ischemic time number of grafts were recorded The primary outcome of the study was Percentage of patients needed additional doses of morphine The secondary outcomes included postoperative visual analogue pain scores performed after patient extubation for pain assessment at rest 0 no pain 10 maximum unbearable pain at time of extubation 8h 12 h18 h and 24 hours postoperatively were recorded when pain score 4 patients were given morphine 005 mgkg administered by a physician who was blinded to the nature of the study time needed for first rescue analgesic postoperative blood pressure and heart rate were recorded immediately on admission then 2 hours 4 hours 6 hours 12 and 24 hours postoperatively in addition to extubation time length of ICU stay the incidence of complications related to the technique such as hemothorax or pneumothorax arrhythmias and local anesthetic toxicity were recorded The end-point was difficult weaning from cardiopulmonary bypass major postoperative bleeding which required re-exploration or allergy to any agents needed for anesthesia All complications were managed according to surgical and medical guidelines
Detailed Description:
Patients were randomly allocated to either Tansversus group T group and general anesthesia N group The patients were randomized using a computer-generated random number in various block sizes in 11 ratio Randomisation was done using the SAS statistical package version 93 SAS institute Cary NC USA by a statistician who was not involved in the study
In the Tansversus group n30 prior to surgical incision a 12 L-RS linear probe of the Sonosite M Turbo ultrasound system National electrical manufacturers USA Probe was put beneath the clavicle next to the sternal edge and the second rib was visualized Sliding the probe on the ribs downward till reaching the fifth rib The probe was rotated 90 degrees and placed in the fouth intercostal space between the fourth and fifth ribs at the edge of the sternum A 20-gauge Tuohy needle was introduced from lateral-to-medial in the plane between the internal intercostal muscles IIM and the transversus thoracic muscle TTM Injection of 1 mL of normal saline was done to identify this plane followed by injection of 15 ml bupivacaine 025 on each side and observation of the local anesthetic spread and pushing on the pleura confirmed the correct injection of the local anesthetic This technique was done on the other side It is important to identify the internal mammary artery IMA which was visualized as a hypoechoic pulsatile structure to avoid inadvertent puncture of the artery and subsequent bleeding and proper visualization of the IMA can facilitate the block In N group n30 the same bilateral technique was done on both sides and 15 ml saline was injected during each side of TTPB technique All the blocks were done by a single experienced anesthetist Drug packs were prepared before commencement of the study by a pharmacist who was unaware of the nature of the study Hemodynamic changes such as high blood pressure or significant tachycardia additional 05- to-1 microgramskg IV doses of fentanyl were administered
Median sternotomy was performed in all cardiac surgical procedures At the end of the cardiac surgical procedure all patients were transferred to the ICU after surgery to maintain the hemodynamics warming them up with control of bleeding and correction of hemoglobin level serum electrolytes and acid-base balance A standard postoperative analgesia was accomplished by acetaminophen 1 gm6 hoursThe protocol for postoperative care was implemented for all patients by well-trained qualified bedside nurses supervised 11 by well-trained ICU consultants All patients were extubated when deemed clinically appropriate according to the local ICU protocol by ICU staff when the patient was able to maintain spontaneous breathing after extubation The patients were encouraged to sit on a chair and mobilize with the assistance of health care providers in the ICU then the physiotherapist became responsible for improving mobility and rehabilitation of the patients till discharge from the hospital
Patient demographic data preoperative medical status left ventricular function and operative data total ischemic time number of grafts were recorded The primary outcome of the study was Percentage of patients needed additional doses of morphine The secondary outcomes included total dose of morphine requirements postoperative visual analogue pain scores performed after patient extubation for pain assessment at rest 0 no pain 10 maximum unbearable pain at time of extubation 8h 12 h18 h and 24 hours postoperatively were recorded when pain score 4 patients were given morphine 005 mgkg administered by a physician who was blinded to the nature of the study time needed for first rescue analgesic postoperative blood pressure and heart rate were recorded immediately on admission then 2 hours 4 hours 6 hours 12 and 24 hours postoperatively in addition to extubation time length of ICU stay the incidence of complications related to the technique such as hemothorax or pneumothorax arrhythmias and local anesthetic toxicity were recorded The end-point was difficult weaning from cardiopulmonary bypass major postoperative bleeding which required re-exploration or allergy to any agents needed for anesthesia All complications were managed according to surgical and medical guidelines
In the Tansversus group n30 prior to surgical incision a 12 L-RS linear probe of the Sonosite M Turbo ultrasound system National electrical manufacturers USA Probe was put beneath the clavicle next to the sternal edge and the second rib was visualized Sliding the probe on the ribs downward till reaching the fifth rib The probe was rotated 90 degrees and placed in the fouth intercostal space between the fourth and fifth ribs at the edge of the sternum A 20-gauge Tuohy needle was introduced from lateral-to-medial in the plane between the internal intercostal muscles IIM and the transversus thoracic muscle TTM Injection of 1 mL of normal saline was done to identify this plane followed by injection of 15 ml bupivacaine 025 on each side and observation of the local anesthetic spread and pushing on the pleura confirmed the correct injection of the local anesthetic This technique was done on the other side It is important to identify the internal mammary artery IMA which was visualized as a hypoechoic pulsatile structure to avoid inadvertent puncture of the artery and subsequent bleeding and proper visualization of the IMA can facilitate the block In N group n30 the same bilateral technique was done on both sides and 15 ml saline was injected during each side of TTPB technique All the blocks were done by a single experienced anesthetist Drug packs were prepared before commencement of the study by a pharmacist who was unaware of the nature of the study Hemodynamic changes such as high blood pressure or significant tachycardia additional 05- to-1 microgramskg IV doses of fentanyl were administered
Median sternotomy was performed in all cardiac surgical procedures At the end of the cardiac surgical procedure all patients were transferred to the ICU after surgery to maintain the hemodynamics warming them up with control of bleeding and correction of hemoglobin level serum electrolytes and acid-base balance A standard postoperative analgesia was accomplished by acetaminophen 1 gm6 hoursThe protocol for postoperative care was implemented for all patients by well-trained qualified bedside nurses supervised 11 by well-trained ICU consultants All patients were extubated when deemed clinically appropriate according to the local ICU protocol by ICU staff when the patient was able to maintain spontaneous breathing after extubation The patients were encouraged to sit on a chair and mobilize with the assistance of health care providers in the ICU then the physiotherapist became responsible for improving mobility and rehabilitation of the patients till discharge from the hospital
Patient demographic data preoperative medical status left ventricular function and operative data total ischemic time number of grafts were recorded The primary outcome of the study was Percentage of patients needed additional doses of morphine The secondary outcomes included total dose of morphine requirements postoperative visual analogue pain scores performed after patient extubation for pain assessment at rest 0 no pain 10 maximum unbearable pain at time of extubation 8h 12 h18 h and 24 hours postoperatively were recorded when pain score 4 patients were given morphine 005 mgkg administered by a physician who was blinded to the nature of the study time needed for first rescue analgesic postoperative blood pressure and heart rate were recorded immediately on admission then 2 hours 4 hours 6 hours 12 and 24 hours postoperatively in addition to extubation time length of ICU stay the incidence of complications related to the technique such as hemothorax or pneumothorax arrhythmias and local anesthetic toxicity were recorded The end-point was difficult weaning from cardiopulmonary bypass major postoperative bleeding which required re-exploration or allergy to any agents needed for anesthesia All complications were managed according to surgical and medical guidelines
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None