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

Post-mastectomy Pain Syndrome Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06443619
• Other study ID #: R.24.04.2582.
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 4, 2024
• Est. completion date: July 10, 2025

Study information

• Verified date: May 2024
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 190
• Est. completion date: July 10, 2025
• Est. primary completion date: June 4, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Post-mastectomy Pain Syndrome

Intervention

Procedure:
• 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).
• 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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The prevalence of chronic pain (post mastectomy pain syndrome)	The prevalence of chronic pain (post mastectomy pain syndrome) of any severity: Numerical pain scale (NRS) >0 on a 0 - 10 scale	3 months after surgery
Secondary	Numerical pain scale (NRS)	Numerical pain scale (NRS) on a 0 - 10 scale, o no pain, 10 worst pain	over 24 hours
Secondary	Postoperative opioid consumption.	total consumption of morphine in the first 24 hours	over 24 hours
Secondary	Patient satisfaction with pain management	Patient satisfaction with pain management assessed 24 h after surgery using an 11-point Likert scale (range, 0-10: 0, entirely unsatisfied; 10,fully satisfied).	24 hours
Secondary	The severity of CPSP and its impact on daily function	The severity of CPSP and its impact on daily function assessed 3 and 6 months after surgery using the revised brief pain inventory (BPI) Chinese-Simplified version	3 and 6 months after surgery