Compare Analgesia Between MTP Block And ESPB in MRM
ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorNational Cancer Institute, Egypt
About this trial
This study is conducted to compare the analgesic efficacy between ultrasound guided Erector Spinae Plane block Vs midpoint transverse process to Pleura block in modified radical mastectomy surgeries
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
ASA I-II.
Undergoing modified radical mastectomy surgery.
Body mass index (BMI) from 18.5 to 30 kg/m2
Disqualifiers
Patient refusal.
Known allergy to local anesthetics.
Bleeding disorders; platelets count <50,000 , prothrombin concentration < 60% or any coagulopathy disorder.
Use of any anti-coagulants.
Trial design
Design model
Parallel
Treatments tested in this trial
Ultrasound guided Erector Spinae Plane block
Procedure/SurgeryGroup E: The block will be performed preoperatively with full aseptic precautions. The ultrasound probe will be placed on the back in a vertical orientation on the lateral side of the posterior median line to identify the transverse process of the 5th thoracic vertebra and erector spine muscle. A skin wheal using 3ml of 1% lidocaine will be made 2 to 3 cm superior to the superior aspect of the transducer. The puncture will be performed using the intra-plane needling technique after local anaesthesia infiltration. A 20-gauge Tuohy needle connected to a syringe containing the anesthetic mixture or saline will be advanced. When the puncture needle touch the transverse process, with no blood, gas, or cerebrospinal fluid observed on aspiration, 20 mL of 0.25% bupivacaine will be administered between the erector spine muscle and transverse process. Local anesthetic diffusion between the transverse process and erector spinae muscle is an indication of a successful puncture.
Ultrasound guided Mid-point to Pleura block
Procedure/SurgeryGroup M: The block will be performed preoperatively with full aseptic precautions. The ultrasound probe will be placed on the back in a vertical orientation on the lateral side of the posterior median line to identify the transverse processes of the 4th and 5th thoracic vertebrae and pleura. A skin wheal using 3ml of 1% lidocaine will be made 2 to 3 cm superior to the superior aspect of the transducer. Using the in plane needling technique in the space between the transverse processes of the 4th and 5th thoracic vertebrae, the puncture needle needle tip will be placed at the mid-point between the transverse process and pleura, with no blood, gas, or cerebrospinal fluid observed on aspiration, 20 mL of 0.25% bupivacaine will be administered. The local anesthetic spread will be noted in the area midway between the transverse process and pleura is an indication of a successful puncture.
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: Erector Spinae Plane block armActive comparator 1 intervention
Group B: Mid-point Transverse Process to Pleura block armActive comparator 1 intervention
Group C: Control armNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
post-operative opioid (morphine) consumption in the 1st 24 hours
Total post operative morphine dosage in mg required
Time frame
24 hoursSecondary outcomes
1
Time to first rescue analgesia, starting after extubation. In minutes
When was the first rescue analgesia given
Time frame
24 hours2
Total dose of fentanyl required intraoperative (including induction dose) in microgram
Total fentanyl dose given intraoperative
Time frame
24 hours3
Numerical pain rating score at 15, 30, 45 and 60 min., 3,6,12 and 24 h after surgery. Score from 0 to 10 where 10 is the worst pain
Pain score post operative
Time frame
24 hours4
Change in heart rate (rate per minute) intraoperatively at 30 minutes interval in comparison to baseline reading.
Change in vital data intraoperative
Time frame
24 hoursSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov