Ultrasound-Guided Mid-Point Transverse Process to Pleura Block for Thoracotomy Incisions
Primary Purpose
Pre-emptive, Postoperative Pain, Thoracotomy
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Midpoint transverse process block group
Sham group
Sponsored by
About this trial
This is an interventional treatment trial for Pre-emptive
Eligibility Criteria
Inclusion Criteria:
- Patients aged 21- and65 years old
- American Society of Anesthesiologists (ASA) II-III
- Scheduled for posterolateral thoracotomy operation under general anesthesia
Exclusion Criteria:
- Patients with bleeding disorders,
- Mental or cognitive dysfunction
- History of chronic analgesic or drug abuse
- Allergy to local anesthetics
- Local infection at site of block
Sites / Locations
- Faculty of Medicine Tanta UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Midpoint transverse process block group
Sham group
Arm Description
Patients will receive midpoint transverse process block after induction of general anesthesia and before surgical incision
Patients will receive general anesthesia and the same intervention steps will be performed i.e., the block under investigation but instead of local anesthetic a placebo (2ml normal saline) will be injected (sham block)
Outcomes
Primary Outcome Measures
The degree of Postoperative Pain
Postoperative pain will be assessed by the Numerical Rating Scale (NRS;0 no pain while 10 is the maximum pain) at 0,4,8,12,18, 24 hours during rest and cough. If the (NRS) is 4 or more, morphine 3mg will be titrated until pain relief is achieved using a short interval between boluses
Secondary Outcome Measures
The amount of Postoperative morphine consumption
Total morphine consumption at 24 hours after surgery
Time to the first rescue analgesia request
Time till administration of first rescue analgesia
SpO2/FiO2 ratio
SpO2/FiO2 ratio at 6,8,12 and 24h postoperatively
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05044858
Brief Title
Ultrasound-Guided Mid-Point Transverse Process to Pleura Block for Thoracotomy Incisions
Official Title
Analgesic Efficacy of Pre-emptive Ultrasound-Guided Mid-Point Transverse Process to Pleura Block for Patients Undergoing Posterolateral Thoracotomy Incisions: Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 24, 2021 (Actual)
Primary Completion Date
September 20, 2022 (Anticipated)
Study Completion Date
September 20, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study is designed to investigate the analgesic efficacy of pre-emptive ultrasound-guided midpoint transverse process to pleura (MTP) block for posterolateral thoracotomy in cardiothoracic surgeries.
Detailed Description
Preemptive preoperative analgesia was first proposed, over the years it has been gradually regarded as an intervention given before incision, facilitating mobilization and functional rehabilitation after surgery, reducing postoperative opioid consumption, decreasing the incidence of adverse events and improving patient satisfaction.
The Mid Transverse Process to Pleura block, described by Costach et al. involves deposition of drug midway between the transverse process and pleura. Costach et al. postulated that the local anesthetic deposited at this point may reach the paravertebral space through several possible mechanisms, such as spread medially through the gap between the superior costotransverse ligament (SCTL) and vertebral bodies, through fenestrations in SCTL, and laterally through the internal intercostal membrane
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-emptive, Postoperative Pain, Thoracotomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Midpoint transverse process block group
Arm Type
Experimental
Arm Description
Patients will receive midpoint transverse process block after induction of general anesthesia and before surgical incision
Arm Title
Sham group
Arm Type
Sham Comparator
Arm Description
Patients will receive general anesthesia and the same intervention steps will be performed i.e., the block under investigation but instead of local anesthetic a placebo (2ml normal saline) will be injected (sham block)
Intervention Type
Procedure
Intervention Name(s)
Midpoint transverse process block group
Intervention Description
After marking the level of the incision by surgeon (commonly T5- T6) The patient will be situated in the lateral position, the block area will be sterilized with povidine-iodine, and high -frequency linear ultrasound probe will be placed oblique parasagittally 3 cm lateral to the spinous process at the level of skin incision. 100-mm short bevel echogenic needle (Contiplex, B.Braun, Germany) will be inserted in plane from cranial to caudal direction. The desired end point of the needle tip will be the midpoint of the line between the posterior border of transverse process and the pleura titrated bolus of 20 ml of 0.25% bupivacaine and dexamethazone 8 mg will be injected at the target site. At end of the surgery general anaesthesia will be stopped with reversal of muscle relaxation and awakening of patient
Intervention Type
Procedure
Intervention Name(s)
Sham group
Intervention Description
General anesthesia will be induced with the same protocol and MTP block will be done but with injection of placebo (2 ml normal saline) instead of local anesthetic .
On arrival to the PACU postoperative Numerical Rating scale at rest and coughing will be recorded, analgesia will be maintained with intravenous paracetamol 1 g every 8 h and required additional rescue analgesia (morphine) at any time will be calculated.
Primary Outcome Measure Information:
Title
The degree of Postoperative Pain
Description
Postoperative pain will be assessed by the Numerical Rating Scale (NRS;0 no pain while 10 is the maximum pain) at 0,4,8,12,18, 24 hours during rest and cough. If the (NRS) is 4 or more, morphine 3mg will be titrated until pain relief is achieved using a short interval between boluses
Time Frame
24 hours postoperative
Secondary Outcome Measure Information:
Title
The amount of Postoperative morphine consumption
Description
Total morphine consumption at 24 hours after surgery
Time Frame
24 hours Postoperative
Title
Time to the first rescue analgesia request
Description
Time till administration of first rescue analgesia
Time Frame
24 hours Postoperative
Title
SpO2/FiO2 ratio
Description
SpO2/FiO2 ratio at 6,8,12 and 24h postoperatively
Time Frame
24 hours Postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients aged 21- and65 years old
American Society of Anesthesiologists (ASA) II-III
Scheduled for posterolateral thoracotomy operation under general anesthesia
Exclusion Criteria:
Patients with bleeding disorders,
Mental or cognitive dysfunction
History of chronic analgesic or drug abuse
Allergy to local anesthetics
Local infection at site of block
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heba A. Mohamed, M.B.B.CH
Phone
+20 111 505 4431
Email
Heba154537_pg@med.tanta.edu.eg
Facility Information:
Facility Name
Faculty of Medicine Tanta University
City
Tanta
State/Province
Elgarbia
ZIP/Postal Code
31527
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heba A. Mohamed, M.B.B.CH
Phone
+20 111 505 4431
Email
Heba154537_pg@med.tanta.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The data will be available upon reasonable request from the principal investigator
IPD Sharing Time Frame
For one year after completion of the study
Learn more about this trial
Ultrasound-Guided Mid-Point Transverse Process to Pleura Block for Thoracotomy Incisions
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