Comparison of the Analgesic Efficacy of Ultrasound-guided Paravertebral Block and Mid-point Transverse Process Pleura Block in Mastectomy Surgery
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Ataturk University
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- to compare the postoperative opioid consumption in the first 24 hours after surgery
Study Overview
Brief Summary
This study was performed to analyze the postoperative analgesic effects of the paravertebral block (PVB) and Mid-Point Transverse Process Pleura (MTP) block after a unilateral mastectomy surgery.
This study included 64 women aged 18-65 years, American Society of Anesthesiologists score I-III, who were scheduled for unilateral simple mastectomy operation due to breast cancer. Patients were randomly assigned to Group 1 (Patients undergoing PVB) or Group 2 (Patients undergoing MTP block) for a ratio of 1:1, including 32 patients each, using a computer-generated table of random numbers and concealed sealed opaque envelopes.
Patients were placed in the prone position. The linear ultrasound probe was fixed to the T3-T4 vertebra level. The skin and subcutaneous tissue were anaesthetized with 2% lidocaine, then 22 gauge 100 mm needle was led in a cranial-cephalic direction to the paravertebral gap. Trapezius, rhomboid, erector spinae muscles were crossed by seeing the tip of the needle. Transverse processes were reached and the intercostal muscles were passed. When the needle reached the paravertebral level in Group 1, and the midpoint level between the transverse process and pleura in Group 2, it was observed that there was no blood or air by aspiration. Then, the needle location was confirmed with 0.5-1 mL of saline, and a 20 mL of 0.25% bupivacaine was applied. Thirty minutes after block application, the sensorial block level was evaluated by pinprick test at the midclavicular line, and the blocked dermatome area was recorded as front and back. Complications developed during the process (such as hypotension, vascular injury, local anaesthetic toxicity) were recorded.Routine general anesthesia protocol was performed to all patients.At the end of the surgery, neuromuscular block antagonization was performed with 4 mg/kg sugammadex. All of the patients were extubated and taken to the postanesthetic care unit (PACU). In the PACU, a patient-controlled analgesia device (PCA) containing fentanyl was administered.
Time to the first request for analgesia, postoperative fentanyl consumption, and VAS score values at rest and in motion at postoperative 1, 4, 8, 12, 16, 20 and 24 hours, the duration of block implementation and the duration of surgery were recorded.
Detailed Description
This prospective randomized controlled trial was performed to analyze the postoperative analgesic effects of the paravertebral block (PVB) and Mid-Point Transverse Process Pleura (MTP) block after a unilateral mastectomy surgery.
This prospective randomized placebo-controlled triple-blind study was approved by the Ethical Committee of Ataturk University, Medical Faculty, Erzurum, Turkey. The study was carried out at the Anesthesiology and Reanimation Department of Ataturk University, Medical Faculty, Erzurum, Turkey.This study included 64 women aged 18-65 years, American Society of Anesthesiologists score I-III, who were scheduled for unilateral simple mastectomy operation due to breast cancer.The day before surgery, patients were assessed by a researcher who was blind to group assignment. All patients were informed about the study, and written informed consent was obtained from all participants who agreed to participate in the study.
This study was planned as triple-blind; patients and investigators were blinded to the group allocation. The patients were fasted for 8 hours before surgery. Before the anesthesia procedure, demographic data of all patients (age, weight, height, ASA physical status), baseline values of heart rate, systolic, diastolic and average blood pressure were recorded. Vascular access was established for all patients via 22-gauge intravenous cannula, and premedication was provided using 0.03 mg/kg of IV midazolam. Patients were randomly assigned to Group 1 (Patients undergoing PVB) or Group 2 (Patients undergoing MTP block) for a ratio of 1:1, including 32 patients each, using a computer-generated table of random numbers and concealed sealed opaque envelopes. An investigator opened the sealed opaque envelopes before the block application. An another anesthetist who was blinded to the group assignment was responsible for collecting intra-and postoperative data. All surgeries were done by the same surgical and anaesthetic teams.
All blocks were fulfilled by the same anesthesiologist, who had at least five years of experience in the profession, with the help of a flat probe (1-8 MHz) and using 22 gauge, 100 mm insulated facet tip needles before general anesthesia. Patients were placed in a sitting position, spinous processes were marked starting from the C7 spinous process to the T6 level. Then, patients were placed in the prone position. After cleaning the area with antiseptic solution, the sterilized linear ultrasonography probe (Esaote MyLab30®, CA631 high-frequency probe, United Kingdom) was covered. The flat probe was placed between two transverse processes on the paramedian plane; transverse processes, superior costotransverse ligament and pleura were consecutively visualized. The linear ultrasound probe was fixed to the T3-T4 vertebra level. The skin and subcutaneous tissue were anesthetized with 2% lidocaine, then 22 gauge 100 mm needle (Stimuplex ®; B Braun, Melsungen, Germany) was led in a cranial-cephalic direction to the paravertebral gap. Trapezius, rhomboid, erector spinae muscles were crossed by seeing the tip of the needle. Transverse processes were reached and the intercostal muscles were passed. When the needle reached the paravertebral level in Group 1, and the midpoint level between the transverse process and pleura in Group 2, it was observed that there was no blood or air by aspiration. Then, the needle location was confirmed with 0.5-1 mL of saline, and a 20 mL of 0.25% bupivacaine was applied. Local anesthetic dissemination was seen in both cranial and caudal directions. Thirty minutes after block application, the sensorial block level was evaluated by pinprick test (normal sensation:0, decreased sensation:1, insensitivity:2) at the midclavicular line, and the blocked dermatome area was recorded as front and back. The duration from placing the patient in the prone position to removing the needle used for the block procedure was defined as the block application duration and recorded. Complications developed during the process (such as hypotension, vascular injury, local anesthetic toxicity) were recorded.
Routine general anesthesia protocol was performed using 2-3 mg/kg IV propofol, 2 µg/kg IV fentanyl and 0.6 mg/kg IV rocuronium. Anesthesia was maintained with desflurane, a fresh gas flow of 3 L/min and a nitrous oxide mixed with oxygen in a 2:1 ratio. During surgery, the patients' systolic, diastolic and average artery blood pressures and oxygen saturation values were recorded in the 5th, 10th, 15th, 20th, 35th, and 50th minutes, and postoperative 1st and 2nd hours. All operations were performed by the same surgical team using the same surgical technique.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
This study was planned as triple-blind; patients and investigators were blinded to the group allocation. An investigator opened the sealed opaque envelopes before the block application. An another anaesthetist who was blinded to the group assignment was responsible for collecting intra-and postoperative data.
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •All patients were informed about the study, and written informed consent was obtained from all participants who agreed to participate in the study.
- •aged 18-65 years
- •ASA I-III
- •scheduled for unilateral simple mastectomy operation due to breast cancer.
Exclusion Criteria
- •bleeding diathesis
- •neurological disease
- •infections at the needle site
- •a history of allergy to any of the drugs used in the study
- •those who had undergone axillary lymph dissection
Arms & Interventions
Group 1: Patients undergoing paravertebral block
After cleaning the area with antiseptic solution, the sterilized linear USG probe (Esaote MyLab30®, CA631 high-frequency probe, United Kingdom) was covered. The flat probe was placed between two transverse processes on the paramedian plane; transverse processes, superior costotransverse ligament and pleura were consecutively visualized. The linear ultrasound probe was fixed to the T3-T4 vertebra level. The skin and subcutaneous tissue were anaesthetized with 2% lidocaine, then 22 gauge 100 mm needle (Stimuplex ®; B Braun, Melsungen, Germany) was led in a cranial-cephalic direction to the paravertebral gap. Trapezius, rhomboid, erector spinae muscles were crossed by seeing the tip of the needle. Transverse processes were reached and the intercostal muscles were passed. When the needle reached the paravertebral level, a 20 mL of 0.25% bupivacaine was applied as a single administration.
Intervention: bupivacaine (Drug)
Group 1: Patients undergoing paravertebral block
After cleaning the area with antiseptic solution, the sterilized linear USG probe (Esaote MyLab30®, CA631 high-frequency probe, United Kingdom) was covered. The flat probe was placed between two transverse processes on the paramedian plane; transverse processes, superior costotransverse ligament and pleura were consecutively visualized. The linear ultrasound probe was fixed to the T3-T4 vertebra level. The skin and subcutaneous tissue were anaesthetized with 2% lidocaine, then 22 gauge 100 mm needle (Stimuplex ®; B Braun, Melsungen, Germany) was led in a cranial-cephalic direction to the paravertebral gap. Trapezius, rhomboid, erector spinae muscles were crossed by seeing the tip of the needle. Transverse processes were reached and the intercostal muscles were passed. When the needle reached the paravertebral level, a 20 mL of 0.25% bupivacaine was applied as a single administration.
Intervention: 22 gauge 100 mm needle (Device)
Group 1: Patients undergoing paravertebral block
After cleaning the area with antiseptic solution, the sterilized linear USG probe (Esaote MyLab30®, CA631 high-frequency probe, United Kingdom) was covered. The flat probe was placed between two transverse processes on the paramedian plane; transverse processes, superior costotransverse ligament and pleura were consecutively visualized. The linear ultrasound probe was fixed to the T3-T4 vertebra level. The skin and subcutaneous tissue were anaesthetized with 2% lidocaine, then 22 gauge 100 mm needle (Stimuplex ®; B Braun, Melsungen, Germany) was led in a cranial-cephalic direction to the paravertebral gap. Trapezius, rhomboid, erector spinae muscles were crossed by seeing the tip of the needle. Transverse processes were reached and the intercostal muscles were passed. When the needle reached the paravertebral level, a 20 mL of 0.25% bupivacaine was applied as a single administration.
Intervention: Propofol (Drug)
Group 1: Patients undergoing paravertebral block
After cleaning the area with antiseptic solution, the sterilized linear USG probe (Esaote MyLab30®, CA631 high-frequency probe, United Kingdom) was covered. The flat probe was placed between two transverse processes on the paramedian plane; transverse processes, superior costotransverse ligament and pleura were consecutively visualized. The linear ultrasound probe was fixed to the T3-T4 vertebra level. The skin and subcutaneous tissue were anaesthetized with 2% lidocaine, then 22 gauge 100 mm needle (Stimuplex ®; B Braun, Melsungen, Germany) was led in a cranial-cephalic direction to the paravertebral gap. Trapezius, rhomboid, erector spinae muscles were crossed by seeing the tip of the needle. Transverse processes were reached and the intercostal muscles were passed. When the needle reached the paravertebral level, a 20 mL of 0.25% bupivacaine was applied as a single administration.
Intervention: fentanyl (Drug)
Group 2: Patients undergoing Mid-Point Transverse Process Pleura (MTP) block
After cleaning the area with antiseptic solution, the sterilized linear USG probe (Esaote MyLab30®, CA631 high-frequency probe, United Kingdom) was covered. The flat probe was placed between two transverse processes on the paramedian plane; transverse processes, superior costotransverse ligament and pleura were consecutively visualized. The linear ultrasound probe was fixed to the T3-T4 vertebra level. The skin and subcutaneous tissue were anaesthetized with 2% lidocaine, then 22 gauge 100 mm needle (Stimuplex ®; B Braun, Melsungen, Germany) was led in a cranial-cephalic direction to the paravertebral gap. Trapezius, rhomboid, erector spinae muscles were crossed by seeing the tip of the needle. Transverse processes were reached and the intercostal muscles were passed. When the needle reached the midpoint level between the transverse process and pleura, a 20 mL of 0.25% bupivacaine was applied as a single administration.
Intervention: bupivacaine (Drug)
Group 2: Patients undergoing Mid-Point Transverse Process Pleura (MTP) block
After cleaning the area with antiseptic solution, the sterilized linear USG probe (Esaote MyLab30®, CA631 high-frequency probe, United Kingdom) was covered. The flat probe was placed between two transverse processes on the paramedian plane; transverse processes, superior costotransverse ligament and pleura were consecutively visualized. The linear ultrasound probe was fixed to the T3-T4 vertebra level. The skin and subcutaneous tissue were anaesthetized with 2% lidocaine, then 22 gauge 100 mm needle (Stimuplex ®; B Braun, Melsungen, Germany) was led in a cranial-cephalic direction to the paravertebral gap. Trapezius, rhomboid, erector spinae muscles were crossed by seeing the tip of the needle. Transverse processes were reached and the intercostal muscles were passed. When the needle reached the midpoint level between the transverse process and pleura, a 20 mL of 0.25% bupivacaine was applied as a single administration.
Intervention: 22 gauge 100 mm needle (Device)
Group 2: Patients undergoing Mid-Point Transverse Process Pleura (MTP) block
After cleaning the area with antiseptic solution, the sterilized linear USG probe (Esaote MyLab30®, CA631 high-frequency probe, United Kingdom) was covered. The flat probe was placed between two transverse processes on the paramedian plane; transverse processes, superior costotransverse ligament and pleura were consecutively visualized. The linear ultrasound probe was fixed to the T3-T4 vertebra level. The skin and subcutaneous tissue were anaesthetized with 2% lidocaine, then 22 gauge 100 mm needle (Stimuplex ®; B Braun, Melsungen, Germany) was led in a cranial-cephalic direction to the paravertebral gap. Trapezius, rhomboid, erector spinae muscles were crossed by seeing the tip of the needle. Transverse processes were reached and the intercostal muscles were passed. When the needle reached the midpoint level between the transverse process and pleura, a 20 mL of 0.25% bupivacaine was applied as a single administration.
Intervention: Propofol (Drug)
Group 2: Patients undergoing Mid-Point Transverse Process Pleura (MTP) block
After cleaning the area with antiseptic solution, the sterilized linear USG probe (Esaote MyLab30®, CA631 high-frequency probe, United Kingdom) was covered. The flat probe was placed between two transverse processes on the paramedian plane; transverse processes, superior costotransverse ligament and pleura were consecutively visualized. The linear ultrasound probe was fixed to the T3-T4 vertebra level. The skin and subcutaneous tissue were anaesthetized with 2% lidocaine, then 22 gauge 100 mm needle (Stimuplex ®; B Braun, Melsungen, Germany) was led in a cranial-cephalic direction to the paravertebral gap. Trapezius, rhomboid, erector spinae muscles were crossed by seeing the tip of the needle. Transverse processes were reached and the intercostal muscles were passed. When the needle reached the midpoint level between the transverse process and pleura, a 20 mL of 0.25% bupivacaine was applied as a single administration.
Intervention: fentanyl (Drug)
Outcomes
Primary Outcomes
to compare the postoperative opioid consumption in the first 24 hours after surgery
Time Frame: Fentanyl consumption in the postoperative 24 hours.
All of the patients were extubated and taken to the postaesthetic care unit (PACU).In the PACU, a patient-controlled analgesia device (PCA) containing fentanyl was administered.
Secondary Outcomes
- to compare postoperative pain scores at rest and in motion.(The first 24 hours after surgery.)
- time to the first opioid analgesic request.(immediately after the surgery.)
- the amount of rescue analgesics(The first 24 hours after surgery.)
Investigators
Mehmet AKSOY
Principal Investigator
Ataturk University