Efficacy of Glucose in Serratus Anterior Plane Block to Reduce the Occurrence of Chronic Post-mastectomy Pain

NCT ID: NCT06443619

Last Updated: 2024-06-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 190 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-04
• Study Completion Date: 2025-07-10

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) (n=30): will receive unilateral USG-deep SAPB 0.4 ml/kg Of 0.25 % isobaric bupivacaine with addition of 15ml glucose 5% to (30 ml total volume); Group (B-N) (n=30): will receive unilateral USG-deep SAPB 0.4 ml/kg Of 0.25% 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 51.7% to 25.6%. 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.

Conditions

Post-mastectomy Pain Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group I

will receive unilateral USG-deep SAPB ; 15 ml 0.5 % isobaric bupivacaine with addition of 15ml glucose 10% to (30 ml total volume).

Group Type: ACTIVE_COMPARATOR

unilateral USG-deep SAPB with glucose

Intervention Type: PROCEDURE

patients will receive unilateral USG-deep SAPB ; 15 ml 0.5 % isobaric bupivacaine with addition of 15ml glucose 10% to (30 ml total volume).

Group Π

will receive unilateral USG-deep SAPB; 15ml 0.5% isobaric bupivacaine to be diluted with 15ml isotonic saline0.9% (30 ml total volume).

Group Type: ACTIVE_COMPARATOR

unilateral USG-deep SAPB without glucose

Intervention Type: PROCEDURE

will receive unilateral USG-deep SAPB; 15ml 0.5% isobaric bupivacaine to be diluted with 15ml isotonic saline0.9% (30 ml total volume).

Interventions

unilateral USG-deep SAPB with glucose

patients will receive unilateral USG-deep SAPB ; 15 ml 0.5 % isobaric bupivacaine with addition of 15ml glucose 10% to (30 ml total volume).

Intervention Type: PROCEDURE

unilateral USG-deep SAPB without glucose

will receive unilateral USG-deep SAPB; 15ml 0.5% isobaric bupivacaine to be diluted with 15ml isotonic saline0.9% (30 ml total volume).

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• American Society of Anesthesiologists physical status I-II
• age ranging from 20 to 60 years
• scheduled for unilateral modified radical mastectomy

Exclusion Criteria

• patient refusal to participate in the study
• infection at site of needle insertion
• hypersensitivity to the studied drugs
• psychotic disorders,
• bilateral MRM ,
• bleeding disorder
• chronic renal or hepatic diseases

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Mahmoud Mohammed Alseoudy

Associate professor of Anesthesia, Intensive care and pain management

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

R.24.04.2582.

Identifier Type: -

Identifier Source: org_study_id