Preoperative Erector Spinae Plane Block Versus Paravertebral Plane Block in Decreasing Post Mastectomy Pain Syndrome
NCT06036979 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51
Last updated 2024-06-28
Summary
Breast cancer is considered the commonest malignancy affecting women with an incidence exceeding one million cases per year. Although it has a favorable prognosis with improved lines of treatment, some complications may still disturb the patient's life quality. One of these complications is post-mastectomy pain syndrome (PMPS) .Regional Anaesthesia (RA) is considered one of the most effective methods in reducing acute pain after breast surgeries, these include pectoral nerves block (PECS), serratus anterior plane block (SAPB), paravertebral plane block (PVPB) and erector spinae plane block (ESPB) . Our study is aiming for comparing the effect of preoperative PVPB versus preoperative ESPB in the prevention of PMPS in patients undergoing unilateral breast surgeries.
Conditions
- Chronic Postoperative Pain
Interventions
- PROCEDURE
-
Paravertebral plane block
With the patients are placed in the sitting position, counting down from C7 spinous process, a high frequency linear ultrasound probe is placed on the spinous process in the parasagittal plane at T5 level and then is slided laterally 2-3 cm to make the transverse processes clearly visualized . Under aseptic conditions, a 22-gauge block needle (50mm, B.Braun, Germany) is inserted using in-plane technique toward the paravertebral space, immediately above the pleura and below the superior costotransverse ligament. The position of the needle is confirmed by the descent of the pleura when injecting 2 to 3 ml of saline solution for hydrolocalization. Then 0.3ml/kg of bupivacaine 0.25% is injected under ultrasound guidance. Block success is defined as reduced sensitivity to cold and pinprick stimuli as compared with the contralateral side 20 minutes after local anesthetic injection.
- PROCEDURE
-
Erector spinae plane block
With the patients are placed in the sitting position, counting down from C7 spinous process, a high frequency linear ultrasound probe is placed on the spinous process in the parasagittal plane at T5 level and then is slided laterally 2-3 cm to make the tips of the transverse processes clearly visualized . The following muscles seen from superficial to deep layer are trapezius, rhomboid major and erector spinae muscles. Under aseptic conditions, a 22-gauge block needle (50mm, B.Braun, Germany) is inserted using in-plane technique to reach the interfascial plane between the transverse process and the erector spinae muscle. Following confirmation of the accurate position of the needle tip with 3-5 ml normal saline solution, 0.3ml/kg of bupivacaine 0.25% is injected under ultrasound guidance. Block success is defined as reduced sensitivity to cold and pinprick stimuli as compared with the contralateral side 20 minutes after local anesthetic injection.
- DRUG
-
Intravenous morphine, ketorlac and paracetamol
• In the control group only we add 10mg intravenous morphine, 30 mg intravenous ketorlac and 1 gm intravenous paracetamol for analgesia.
Sponsors & Collaborators
-
National Cancer Institute, Egypt
lead OTHER
Principal Investigators
-
Suzan Ahmed, MS degree · National Cancer Institute, Egypt
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-07-01
- Primary Completion
- 2024-10-01
- Completion
- 2025-02-01
Countries
- Egypt
Study Locations
More Related Trials
-
Paravertebral Morphine Versus Dexmedetomidine on Acute and Chronic Postmastectomy Pain
NCT02935933 ·Status: UNKNOWN ·Phase: PHASE1/PHASE2
-
The Efficacy of Using Pentoxifylline in Patients Undergoing Breast Cancer Surgery
NCT06087237 ·Status: COMPLETED ·Phase: PHASE2
-
Pre-op Paravertebral Blocks to Decrease Post-op Pain Following Mastectomy With Immediate Tissue Expander (TE) Reconstruction
NCT02161705 ·Status: TERMINATED ·Phase: PHASE3
-
Impact of Erector Spinae Plane Block on Chronic Postsurgical Pain in Breast Cancer Patients
NCT05494502 ·Status: RECRUITING ·Phase: NA
-
Efficacy of Tramadol With Levobupivacaine for Modified Pectoral Nerve Block
NCT02625506 ·Status: COMPLETED ·Phase: NA
-
Dexmedetomedine and Ketamine in Erector Spinae Block for Postoperative Analgesia Following Mastectomy.
NCT05727098 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Pain Relieving Potentials of Combination of Oral Duloxetine and Intravenous Magnesium Sulphate in Post Mastectomy Pain
NCT06087211 ·Status: COMPLETED ·Phase: NA
-
Efficacy of Transdermal Fentanyl Patches in Relief of Acute Postoperative Pain After Mastectomy
NCT03051503 ·Status: UNKNOWN ·Phase: PHASE4
-
Efficacy of Ketamine Added to Local Anesthetic in Modified Pectoral Block for Management of Postoperative Pain
NCT02620371 ·Status: COMPLETED ·Phase: PHASE3
-
Effect of Liposome Bupivacaine Serratus Plane Block on Postoperative Hyperalgesia and Chronic Post-surgical Pain in Patients Undergoing Radical Mastectomy
NCT07289178 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1/PHASE2
-
Analgesic Effect to Postoperative Pain After Mastectomy: Ultrasound-guided Serratus Anterior Plane Block
NCT02483923 ·Status: COMPLETED ·Phase: NA
-
Infusion of Dexmedetomidine Versus Lidocaine in Management of Acute Postoperative Pain After Modified Radical Mastectomy
NCT06974656 ·Status: COMPLETED ·Phase: NA
-
Assessing Efficacy of Intravenous Acetaminophen for Perioperative Pain Treatment in Spinal Surgery
NCT05764707 ·Status: COMPLETED ·Phase: PHASE2
-
Ultrasound Guided Pectoral Nerve I and II Blocks in Multimodal Analgesia for Breast Surgery
NCT02672813 ·Status: UNKNOWN ·Phase: PHASE4
-
Serratus Anterior Plane Block in Patients Undergoing Mastectomy
NCT03154658 ·Status: COMPLETED ·Phase: PHASE4
-
Ketamine as Adjunctive Analgesic With Bupivacaine in Paravertebral Analgesia for Breast Cancer Surgery
NCT02462681 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Effects of Regional Anesthesia Following Mastectomy
NCT05276440 ·Status: COMPLETED
-
PECS Block vs. Multimodal Analgesia for Prevention of Persistent Postoperative Pain in Breast Surgery
NCT03084536 ·Status: COMPLETED ·Phase: PHASE2
-
Thoracic Paravertebral Block Versus IV Fentanyl Infusion
NCT03903367 ·Status: UNKNOWN ·Phase: PHASE1/PHASE2
-
PECTORAL PLANE BLOCK COMPAIRED TO ERECTOR SPINAE PLANE BLOCK IN MULTIMODAL ANALGESIA FOR MASTECTOMY PATIENTS IN SOUTH ASIAN POPULATION -A PROSPECTIVE RANDOMISED CONTROL TRIAL
NCT07197177 ·Status: COMPLETED ·Phase: NA
-
IV Dexmedetomidine vs Oral Gabapentin and Their Combination for Postoperative Analgesia in Cancer Patients Undergoing Modified Radical Mastectomy
NCT06354478 ·Status: COMPLETED ·Phase: NA
-
Effect of Infusion of Lidocaine, Magnesium and Remifentanil Perioperatively in Patients Undergoing Mastectomy
NCT02309879 ·Status: COMPLETED ·Phase: PHASE4
-
Multimodal Analgesia in Major Abdominal Pediatric Cancer Surgeries
NCT03580980 ·Status: COMPLETED ·Phase: NA
-
Analgesic Protocol With Gabapentin Dexmedetomidine For Postoperative Pain Managment
NCT04976374 ·Status: UNKNOWN ·Phase: NA
-
A Randomized Clinical Trial
NCT03947463 ·Status: COMPLETED ·Phase: NA