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

NCT06443619 | Not Yet Recruiting

• 1 other identifier: R.24.04.2582.
• Study Type: interventional
• Target: 190
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Post-mastectomy Pain Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Numerical pain scale (NRS)

  over 24 hours

• Postoperative opioid consumption.

  over 24 hours

• Patient satisfaction with pain management

  24 hours

• The severity of CPSP and its impact on daily function

  3 and 6 months after surgery

Study Arms (2)

Group I

ACTIVE COMPARATOR

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

Group Π

ACTIVE COMPARATOR

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

Interventions

unilateral USG-deep SAPB with glucose 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 I

unilateral USG-deep SAPB without glucose PROCEDURE

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

Group Π

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

MeSH Terms

Interventions

Glucose

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of Anesthesia, Intensive care and pain management

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: June 5, 2024
• Study Start: June 4, 2024
• Primary Completion: June 4, 2025
• Study Completion: July 10, 2025
• Last Updated: June 5, 2024

Record last verified: 2024-05