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

Efficacy of Glucose Addition to Bupivacaine in Serratus Anterior Plane Block to Reduce the Occurrence of Chronic Post-mastectomy Pain: A Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Post-mastectomy Pain Syndrome
• Intervention / Treatment: Procedure: unilateral USG-deep SAPB with glucose; Procedure: unilateral USG-deep SAPB without glucose

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.

• Study Type: Interventional
• Enrollment (Estimated): 190
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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).	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).
Active Comparator: 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).	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical pain scale (NRS)	Numerical pain scale (NRS) on a 0 - 10 scale, o no pain, 10 worst pain	over 24 hours
Postoperative opioid consumption.	total consumption of morphine in the first 24 hours	over 24 hours
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
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

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Estimated): June 4, 2024
• Primary Completion (Estimated): June 4, 2025
• Study Completion (Estimated): July 10, 2025

Study Registration Dates

• First Submitted: May 30, 2024
• First Submitted That Met QC Criteria: May 30, 2024
• First Posted (Actual): June 5, 2024

Study Record Updates

• Last Update Posted (Actual): June 5, 2024
• Last Update Submitted That Met QC Criteria: May 30, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: R.24.04.2582.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No