NCT Number: NCT07798115
This study aims to evaluate whether adding magnesium sulfate to a combined costoclavicular and suprascapular nerve block improves postoperative pain control in patients undergoing shoulder arthroscopy. The study will compare pain management outcomes between patients receiving the nerve block with magnesium sulfate and those receiving the nerve block without magnesium sulfate. The main outcome will be the time to first rescue analgesia after surgery.
Trial opening soon.
Get Notified18 year–50 year
All sexes
Interventional
Not applicable
Asyut, Egypt
Ahmed Shaban Abd Elbadea Khalifa, Assistant Lecturer
CONTACT
Ahmed Shaban Abd Elbadea Khalifa, Assistant lecturer
SUB_INVESTIGATOR
Eman Ahmed Ismail, professor
PRINCIPAL_INVESTIGATOR
Mohamed Mohamed Abdel Latif, professor
PRINCIPAL_INVESTIGATOR
Mohamed Talaat Mohamed, Lecturer
CONTACT
Mohamed Talaat Mohamed, Lecturer
SUB_INVESTIGATOR
This randomized clinical trial will evaluate the analgesic effect of adding magnesium sulfate to a combined costoclavicular and suprascapular nerve block in patients undergoing shoulder arthroscopy. Shoulder arthroscopy can be associated with significant postoperative pain, and effective regional anesthesia may improve postoperative analgesia and reduce the need for rescue analgesics.
Eligible patients undergoing shoulder arthroscopy will be randomly assigned to receive either a combined costoclavicular and suprascapular nerve block with magnesium sulfate as an adjuvant or the same nerve block without magnesium sulfate. Standardized anesthetic and postoperative analgesic protocols will be applied to both groups.
The primary outcome will be the time to first rescue analgesia after surgery. Secondary outcomes will include postoperative pain scores and other relevant analgesic and safety outcomes during the postoperative observation period.
The study aims to determine whether the addition of magnesium sulfate can prolong the duration of analgesia and improve postoperative pain management following shoulder arthroscopy.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
"Bupivacaine 0.5% will be used as the local anesthetic for ultrasound-guided costoclavicular and suprascapular nerve blocks. A total of 25 mg (5 mL) will be administered for the costoclavicular nerve block and 50 mg (10 mL) for the suprascapular nerve block, for a total dose of 75 mg per participant."
"Magnesium sulfate 150 mg (1.5 mL) will be used as an adjuvant to bupivacaine in each ultrasound-guided nerve block. A total of 300 mg (3 mL) of magnesium sulfate will be administered per participant, with 150 mg added to the costoclavicular nerve block and 150 mg added to the suprascapular nerve block."
"Normal saline (0.9% sodium chloride) will be used as the control adjuvant, with 1.5 mL added to the local anesthetic solution for the costoclavicular nerve block and 1.5 mL added to the local anesthetic solution for the suprascapular nerve block, for a total volume of 3 mL per participant."
"A single-shot ultrasound-guided costoclavicular nerve block will be performed using 5 mL of 0.5% bupivacaine (25 mg), with either 1.5 mL of magnesium sulfate (150 mg) or 1.5 mL of 0.9% normal saline, according to the assigned study group."
"A single-shot ultrasound-guided suprascapular nerve block will be performed using 10 mL of 0.5% bupivacaine (50 mg), with either 1.5 mL of magnesium sulfate (150 mg) or 1.5 mL of 0.9% normal saline, according to the assigned study group."
Time frame: From discharge from PACU until 24 hours postoperatively.
Time to first rescue analgesia will be measured from the time of discharge from the Post-Anesthesia Care Unit (PACU) until the first administration of rescue analgesic medication for 24 hour due to postoperative pain. Numeric Rating Scale (NRS): Pain intensity was assessed using the 11-point Numeric Rating Scale (NRS), in which 0 = no pain and 10 = the worst pain imaginable.
Time frame: At predetermined time points after surgery at ( 2h,6h,12h,18h,24h) during the first 24 hours postoperatively.
Postoperative pain intensity will be assessed from the end of surgery for 24 hours postoperatively using the Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate worse pain.
Time frame: First 24 hours postoperatively (one day).
The total amount of rescue analgesia consumed during the first 24 hours after surgery will be recorded.
Time frame: From completion of the nerve block until the first administration of rescue analgesia24 hours postoperatively.
Duration of sensory block will be assessed as the time interval from completion of the nerve block to the first administration of rescue analgesia 24 hours postoperatively.
Time frame: From baseline before the nerve block until the end of surgery.
Heart rate will be recorded at predefined perioperative time points to assess hemodynamic stability from baseline before surgery until end of surgery.
Time frame: From baseline before anesthesia induction until 24 hours postoperatively.
Systolic blood pressure will be recorded at baseline and at predefined intraoperative every 5 minutes and postoperative time points at (2h, 6h,12h,24h).
Time frame: From baseline before anesthesia induction until 24 hours postoperatively.
Diastolic blood pressure will be recorded at baseline and at predefined intraoperative every 5 minutes and postoperative time points at (2h, 6h,12h,24h).
Time frame: From baseline before anesthesia induction until 24 hours postoperatively.
Mean Arterial Pressure will be recorded at baseline and at predefined intraoperative every 5 minutes and postoperative time points at (2h, 6h,12h,24h).
Time frame: From performance of the nerve blocks until 24 hours postoperatively.
The incidence of adverse events related to the regional anesthesia technique, including symptoms or complications associated with the nerve blocks, will be recorded.
Contact information is provided by the study sponsor or research team.
Ahmed Shaban Abd elbadea Khalifa, Assistant lecturer
CONTACT
Mohamed Talaat Mohamed, lecturer
CONTACT
Assiut University
Other
Analgesic Effect of Additional Magnesium Sulfate to Standard Combined Costoclavicular-suprascapular Block in Shoulder Arthroscopy.
Acronym: CCSS-Mg
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07762417
Neurologic Manifestations, Pain
View Trial DetailsNCT07695025
Neurologic Manifestations, Pain
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT07668648
Neurologic Manifestations, Pain
Bursa, Nilüfer, Turkey (Türkiye)
View Trial DetailsNCT06973447
Neurologic Manifestations, Pain
Sivas, Turkey (Türkiye)
View Trial Details