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

NCT04872192 | Completed DMC

• 1 other identifier: FMASU R 20/ 2020/ 2021
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Keywords

transversus thoracic muscle block; adults; cardiac surgery

Outcome Measures

Primary Outcomes (1)

• Percentage of patients needed additional doses of morphine

  number of patients requiring additional doses of morphine

  24 hours postoperative

Secondary Outcomes (2)

• postoperative visual analogue pain scores

  time of extubation, 8 hours, 12 hours,18 hours and 24 hours postoperatively

• postoperative total morphine dose

  24 hours postoperative

Study Arms (2)

transversus

ACTIVE COMPARATOR

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

Other: transversus thoracic muscle plane block

general anaesthesia group

SHAM COMPARATOR

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

Other: general anaesthesia

Interventions

transversus thoracic muscle plane block OTHER

transversus thoracic muscle plane block by injection of 15 ml of bupivacaine 0.25% on each side combined with general anaesthesia

transversus

general anaesthesia OTHER

transversus thoracic muscle plane block by injection of 15 ml of saline on each side combined with general anaesthesia

general anaesthesia group

Eligibility Criteria

• Age: 55 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams university

Cairo, 11566, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Anesthesia, General

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• Hoda Shokri

  Ain Shams University

  PRINCIPAL INVESTIGATOR

• Ihab Ali

  AinShams university

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor of anaesthesia

Study Record Dates

• First Submitted: May 2, 2021
• First Posted: May 4, 2021
• Study Start: May 27, 2021
• Primary Completion: July 31, 2021
• Study Completion: August 18, 2021
• Last Updated: October 11, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 4 months
• 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.

Locations

EG (1)