Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To compare the analgesic efficacy of dexmedetomidine and magnesium sulphate as adjuvants to levobupivacaine in erector spinae plane block in modified radical mastectomy surgery for acute and chronic pain management.
3 groups.
Group (C) / (I):20 patient (control group) :
Patients will receive 20 ml 0.25% levobupivacaine into the interfascial plane below erector spinae muscle at level of T5.
Group (D)/ (II) :20 patient (Dexmetonidine group) :
Patient will receive 20ml 0.25% levobupivacaineas above + 1μ/kg dexmedetomidine.
Group (M) / (III) : 20 patient (magnesium slphate group) :
Patient will receive 20ml 0.25% levobupivacaineas above + 0.7 mg/kg MgSo4 . The patient, the anesthesiologist who administered the drugs, and the data collector will be blinded to the study drugs.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group (C) (control group): | Placebo Comparator | Patient will receive 20 ml 0.25% levobupivacaine into interfascial plane below erector spinae muscle at level of T5. |
|
| Group (D) (Dexmetonidine group): | Active Comparator | Patient will receive 20ml 0.25% levobupivacaine + 1μ/kg dexmedetomidine into interfascial plane below erector spinae muscle at level of T5.. |
|
| Group (M) (magnesium slphate group): | Active Comparator | Patient will receive 20ml 0.25% levobupivacaine + 0.7 mg/kg MgSo4 into interfascial plane below erector spinae muscle at level of T5.. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ultrasound guided erector spinae plan block using bupivacaine for modified radical mastectomy | Procedure | Ultrasound guided Erector spinae plane (ESP) block will be given with patient in sitting position depending on surgical site (left or right) ESP block will be given using high frequency linear u/s transducer, the probe is placed in longitudinal orientation lateral to thoracic fifth spinous process, then Trapezius muscle, Rhomboidus major muscle, and erector spinae muscle |
| Measure | Description | Time Frame |
|---|---|---|
| analgesia requirement | first request for analgesia and total analgesia requirements | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| chronic pain assessment | Assessment of chronic pain at 1-3 and 6 month post-operatively using LANSS pain score. a score of 12 or more is suggestive of neuropathic pain. | 6 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| peter R Edward, MSc | specialist | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South Egypt Cancer Institute | Asyut | 171516 | Egypt |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| ultrasound guided erector spinae plan block with bupivacaine and Dexmetonidine for modified radical mastectomy | Procedure | Ultrasound guided Erector spinae plane (ESP) block will be given with patient in sitting position depending on surgical site (left or right) ESP block will be given using high frequency linear u/s transducer, the probe is placed in longitudinal orientation lateral to thoracic fifth spinous process, then Trapezius muscle, Rhomboidus major muscle, and erector spinae muscle |
|
| ultrasound guided erector spinae plan block with bupivacaine and magnesium slphate for modified radical mastectomy | Procedure | Ultrasound guided Erector spinae plane (ESP) block will be given with patient in sitting position depending on surgical site (left or right) ESP block will be given using high frequency linear u/s transducer, the probe is placed in longitudinal orientation lateral to thoracic fifth spinous process, then Trapezius muscle, Rhomboidus major muscle, and erector spinae muscle |
|
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D015411 | Mastectomy, Modified Radical |
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D015409 | Mastectomy, Radical |
| D008408 | Mastectomy |
| D013514 | Surgical Procedures, Operative |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
Not provided
Not provided