Ignite Creation Date:
2024-05-06 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 1:55 PM
Study NCT ID:
NCT04732390
Status:
UNKNOWN
Last Update Posted:
2021-02-01
First Post:
2021-01-09
Brief Title:
Analgesic Efficacy of Magnesium Sulphate as an Adjuvant to Levobupivacaine in Erector Spinae Block for Acute Pain Management in Modified Radical Mastectomy
Sponsor:
South Egypt Cancer Institute
Organization:
South Egypt Cancer Institute
Study Overview
Official Title:
Analgesic Efficacy of Magnesium Sulphate as an Adjuvant to Levobupivacaine in Erector Spinae Block for Acute Pain Management in Modified Radical Mastectomy
Status:
UNKNOWN
Status Verified Date:
2021-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate the analgesic efficacy of magnesium sulphate as adjuvants to levobupivacaine in erector spinae plane block in modified radical mastectomy surgery for acute pain management
Detailed Description:
The participating female will be randomly allocated using computer generated randomization program httpwwwrandoilerorg into one of 2 groups
Group C I20 patients control group
Patient will receive 20 ml 025 levobupivacaine into interfascial plane below erector spinae muscle at level of T5
Group M III 20 patients magnesium slphate group
Patient will receive 20ml 025 levobupivacaine above 07 mgkg MgSo4 The patient the anesthesiologist who administered the drugs and the data collector will be blinded to the study drugs
Study protocol
Pre-operative and post-operative procedure
Premedication will be given after complete fasting hours after applying standard monitors noninvasive blood pressure pulse oximetery ECG temperature and capnography an intravenous cannula will be placed and secured
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 us transducer the probe is placed in longitudinal orientation lateral to thoracic fifth spinous process then Trapezius muscle Rhomboidus major muscle and erector spinae muscle are identified from surface we deposite20 ml of 025 levobupivacaine into interfacial plane below erector spinae muscle
General anesthesia will be induced with fentanyl l μg kg propofol 2mg kg muscle relaxant atracurium 05 mgkg inhalational anesthesia isoflurane or sevoflurane No other narcotic analgesic or sedative will be administrated during operative period
Standard monitor mean arterial blood pressure heart rate oxygen saturation end-tidal Co2 will observed and recorded every 30 min till end of surgery
Post-operative
The patient will be transferred to the post anesthesia care unit PACU and will be monitored for
1 Vital signs heart rate noninvasive blood pressure and oxygen saturation
2 RASS score Richmond Agitation Sedation scale with its 4-5 score range will be used to assess sedation post-operative considered sedation -2 table 1
3 Numerical Rating Score NRS pain score with its 0-10 score range will be used to assess pain immediately post-operative and then at 2 4 6 8 1218and 24hour in the post-operative period figure 1
4 Time and amount to request analgesia PCA patient controlled analgesia morphine demand dose 1-2 mg lock out 6-10 min at NRS3
5 Side effect of studied drugs as hypotension sedation respiration depression and vomiting and complication of the block for 24h post- operative
Group C I20 patients control group
Patient will receive 20 ml 025 levobupivacaine into interfascial plane below erector spinae muscle at level of T5
Group M III 20 patients magnesium slphate group
Patient will receive 20ml 025 levobupivacaine above 07 mgkg MgSo4 The patient the anesthesiologist who administered the drugs and the data collector will be blinded to the study drugs
Study protocol
Pre-operative and post-operative procedure
Premedication will be given after complete fasting hours after applying standard monitors noninvasive blood pressure pulse oximetery ECG temperature and capnography an intravenous cannula will be placed and secured
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 us transducer the probe is placed in longitudinal orientation lateral to thoracic fifth spinous process then Trapezius muscle Rhomboidus major muscle and erector spinae muscle are identified from surface we deposite20 ml of 025 levobupivacaine into interfacial plane below erector spinae muscle
General anesthesia will be induced with fentanyl l μg kg propofol 2mg kg muscle relaxant atracurium 05 mgkg inhalational anesthesia isoflurane or sevoflurane No other narcotic analgesic or sedative will be administrated during operative period
Standard monitor mean arterial blood pressure heart rate oxygen saturation end-tidal Co2 will observed and recorded every 30 min till end of surgery
Post-operative
The patient will be transferred to the post anesthesia care unit PACU and will be monitored for
1 Vital signs heart rate noninvasive blood pressure and oxygen saturation
2 RASS score Richmond Agitation Sedation scale with its 4-5 score range will be used to assess sedation post-operative considered sedation -2 table 1
3 Numerical Rating Score NRS pain score with its 0-10 score range will be used to assess pain immediately post-operative and then at 2 4 6 8 1218and 24hour in the post-operative period figure 1
4 Time and amount to request analgesia PCA patient controlled analgesia morphine demand dose 1-2 mg lock out 6-10 min at NRS3
5 Side effect of studied drugs as hypotension sedation respiration depression and vomiting and complication of the block for 24h post- operative
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None