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Analgesic Efficacy of Transversus Thoracic Muscle Plane Block on Post-sternotomy Pain

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
transversus thoracic muscle plane block
general anaesthesia
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring transversus thoracic muscle block, adults, cardiac surgery

Eligibility Criteria

55 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age between 55-74 years
  • ASA II-III
  • BMI<30

Exclusion Criteria:

  • patients who were preoperatively intubated for more than 24 hours
  • patients with complex cardiac procedures
  • patient inability to communicate patients with severe pulmonary hypertension in addition to any contraindication to regional anesthesia

Sites / Locations

  • Ain shams university

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

transversus

general anaesthesia group

Arm Description

patients received transversus thoracic muscle plane block and injection of 15 ml bupivacaine 0.25% on each side.

the same bilateral technique was done on both sides and 15 ml saline was injected during each side of TTPB technique.

Outcomes

Primary Outcome Measures

Percentage of patients needed additional doses of morphine
number of patients requiring additional doses of morphine

Secondary Outcome Measures

postoperative visual analogue pain scores
pain assessment at rest (0 = no pain, 10 = maximum unbearable pain)
postoperative total morphine dose
dose of postoperative rescue morphine requirements

Full Information

First Posted
May 2, 2021
Last Updated
October 7, 2021
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT04872192
Brief Title
Analgesic Efficacy of Transversus Thoracic Muscle Plane Block on Post-sternotomy Pain
Official Title
Evaluation of the Analgesic Efficacy of Bilateral Ultrasound-guided Transversus Thoracic Muscle Plane Block on Post-sternotomy Pain: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
May 27, 2021 (Actual)
Primary Completion Date
July 31, 2021 (Actual)
Study Completion Date
August 18, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Patients were randomly allocated to either Tansversus group (T group) and general anesthesia (N group).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 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 h,18 h and 24 hours postoperatively were recorded, when pain score >4, patients were given morphine 0.05 mg/kg 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 1:1 ratio. Randomisation was done using the SAS statistical package version 9.3 (SAS institute, Cary, NC, USA) by a statistician who was not involved in the study. In the Tansversus group (n=30), 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 0.25% 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 (n=30), 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 0.5- to-1 micrograms/kg 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 gm/6 hours.The protocol for postoperative care was implemented for all patients by well-trained, qualified bedside nurses supervised 1:1 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 h,18 h and 24 hours postoperatively were recorded, when pain score >4, patients were given morphine 0.05 mg/kg 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
transversus thoracic muscle block, adults, cardiac surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
transversus
Arm Type
Active Comparator
Arm Description
patients received transversus thoracic muscle plane block and injection of 15 ml bupivacaine 0.25% on each side.
Arm Title
general anaesthesia group
Arm Type
Sham Comparator
Arm Description
the same bilateral technique was done on both sides and 15 ml saline was injected during each side of TTPB technique.
Intervention Type
Other
Intervention Name(s)
transversus thoracic muscle plane block
Intervention Description
transversus thoracic muscle plane block by injection of 15 ml of bupivacaine 0.25% on each side combined with general anaesthesia
Intervention Type
Other
Intervention Name(s)
general anaesthesia
Intervention Description
transversus thoracic muscle plane block by injection of 15 ml of saline on each side combined with general anaesthesia
Primary Outcome Measure Information:
Title
Percentage of patients needed additional doses of morphine
Description
number of patients requiring additional doses of morphine
Time Frame
24 hours postoperative
Secondary Outcome Measure Information:
Title
postoperative visual analogue pain scores
Description
pain assessment at rest (0 = no pain, 10 = maximum unbearable pain)
Time Frame
time of extubation, 8 hours, 12 hours,18 hours and 24 hours postoperatively
Title
postoperative total morphine dose
Description
dose of postoperative rescue morphine requirements
Time Frame
24 hours postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age between 55-74 years ASA II-III BMI<30 Exclusion Criteria: patients who were preoperatively intubated for more than 24 hours patients with complex cardiac procedures patient inability to communicate patients with severe pulmonary hypertension in addition to any contraindication to regional anesthesia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hoda Shokri
Organizational Affiliation
Ain Shams University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ihab Ali
Organizational Affiliation
AinShams university
Official's Role
Study Director
Facility Information:
Facility Name
Ain shams university
City
Cairo
ZIP/Postal Code
11566
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
study protocol
IPD Sharing Time Frame
4 months
IPD Sharing Access Criteria
The collected data are coded, tabulated, and statistically analyzed using statistical package for social sciences software, version 17.0 (SPSS Inc., Chicago, Illinois, USA). Descriptive statistics are carried out for numerical parametric data and presented as mean±SD, whereas categorical data are presented as number and percentage. Variables such as demographic data and comorbidities are compared using the χ2-test. A P value less than 0.05 was considered significant.

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Analgesic Efficacy of Transversus Thoracic Muscle Plane Block on Post-sternotomy Pain

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