Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06443619
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-05-30
Brief Title:
Efficacy of Glucose in Serratus Anterior Plane Block to Reduce the Occurrence of Chronic Post-mastectomy Pain
Sponsor:
Mansoura University
Organization:
Mansoura University
Study Overview
Official Title:
Efficacy of Glucose Addition to Bupivacaine in Serratus Anterior Plane Block to Reduce the Occurrence of Chronic Post-mastectomy Pain A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
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:
Nearly 50 of patients suffer from chronic pain following breast cancer surgery Several regional anesthesia techniques including paravertebral block erector spinae plane block pectoral nerves block and serratus anterior plane block have been applied for acute pain control and prevention of chronic pain after breast cancer surgery Exploiting the beneficial effect of glucose in regulating neuroinflammation and neuropathic pain we hypothesize that the addition of glucose to bupivacaine could be superior to bupivacaine in ultrasound-guided SAPB in improving the quality of postoperative analgesia and preventing chronic pain after mastectomy Patients will be randomly allocated into one of two equal groups 30 patients each the study group Group I B-D n30 will receive unilateral USG-deep SAPB 04 mlkg Of 025 isobaric bupivacaine with addition of 15ml glucose 5 to 30 ml total volume Group B-N n30 will receive unilateral USG-deep SAPB 04 mlkg Of 025 isobaric bupivacaine to be diluted with 15ml isotonic saline 30 ml total volume The occurence of postmastectomy pain 3 months after surgery will be the primary outcome
Detailed Description:
Breast cancer is the most commonly diagnosed malignancy and the leading cause of cancer-related death in women Although early detection and treatment have increased survival rates chronic postsurgical pain CPSP is one of the most common complications of breast cancer surgery
Nearly 50 of patients suffer from chronic pain following breast cancer surgery which is known as Post Mastectomy Pain Syndrome PMPS There are several risk factors for PMPS including younger age invasive surgical interventions adjuvant radiation therapy following surgery and high pain score in the early postoperative period Several regional anesthesia RA techniques including paravertebral block PVB pectoral nerves PECS block and the erector spinae plane block ESPB have been applied for acute pain control and prevention of chronic pain after breast cancer surgery BCS
Recently the serratus anterior plane block SAPB has become a newer interfacial plane block that appears to be safe and easily performed under ultrasound de la Torre et al 2014 A study concluded that preoperative SAPB with ropivacaine reduced the prevalence of CPSP at 3 months postoperativelyfrom 517 to 256 Various adjuvants like fentanyl clonidine magnesium sulphate nalbuphine and dexamethasone have been used with bupivacaine in different blocks for prolonging the duration of analgesia and prevention of chronic pain Using glucose 5 has been progressively applied to treat many peripheral entrapment neuropathies and has been proven to have outstanding effects in a few high-quality studies Glucose 5 could decrease neurogenic inflammation by impeding the discharge of substance P and calcitonin gene-related peptides which are pro-nociceptive substances that contribute to neurogenic inflammation and neuropathic pain Exploiting the beneficial effect of glucose in regulating neuroinflammation and neuropathic pain we hypothesize that the addition of glucose as an adjuvant to bupivacaine in the regional anesthesia technique for breast surgery could improve the quality of postoperative analgesia and prevent chronic pain after mastectomy We hypothesize that the addition of glucose to bupivacaine could be superior to bupivacaine in ultrasound-guided SAPB in improving the quality of postoperative analgesia and preventing chronic pain after mastectomy This randomized double-blind study was designed to compare the efficacy and safety of co-administration of glucose and bupivacaine study group and bupivacaine alone control group in ultrasound-guided SAPB in patients undergoing modified radical mastectomy using the occurence of postmastectomy pain 3 months after surgery as the primary outcome
Nearly 50 of patients suffer from chronic pain following breast cancer surgery which is known as Post Mastectomy Pain Syndrome PMPS There are several risk factors for PMPS including younger age invasive surgical interventions adjuvant radiation therapy following surgery and high pain score in the early postoperative period Several regional anesthesia RA techniques including paravertebral block PVB pectoral nerves PECS block and the erector spinae plane block ESPB have been applied for acute pain control and prevention of chronic pain after breast cancer surgery BCS
Recently the serratus anterior plane block SAPB has become a newer interfacial plane block that appears to be safe and easily performed under ultrasound de la Torre et al 2014 A study concluded that preoperative SAPB with ropivacaine reduced the prevalence of CPSP at 3 months postoperativelyfrom 517 to 256 Various adjuvants like fentanyl clonidine magnesium sulphate nalbuphine and dexamethasone have been used with bupivacaine in different blocks for prolonging the duration of analgesia and prevention of chronic pain Using glucose 5 has been progressively applied to treat many peripheral entrapment neuropathies and has been proven to have outstanding effects in a few high-quality studies Glucose 5 could decrease neurogenic inflammation by impeding the discharge of substance P and calcitonin gene-related peptides which are pro-nociceptive substances that contribute to neurogenic inflammation and neuropathic pain Exploiting the beneficial effect of glucose in regulating neuroinflammation and neuropathic pain we hypothesize that the addition of glucose as an adjuvant to bupivacaine in the regional anesthesia technique for breast surgery could improve the quality of postoperative analgesia and prevent chronic pain after mastectomy We hypothesize that the addition of glucose to bupivacaine could be superior to bupivacaine in ultrasound-guided SAPB in improving the quality of postoperative analgesia and preventing chronic pain after mastectomy This randomized double-blind study was designed to compare the efficacy and safety of co-administration of glucose and bupivacaine study group and bupivacaine alone control group in ultrasound-guided SAPB in patients undergoing modified radical mastectomy using the occurence of postmastectomy pain 3 months after surgery as the primary outcome
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?:
None
Is an FDA AA801 Violation?:
None