Serratus Plane Block in Preventing Postoperative Pain of Mastectomy

Feng Xia

Status: Completed

Conditions: Breast Cancer; Chronic Pain; Serratus Plane Block

Treatments: Procedure: serratus plane block with local anesthetic; Procedure: serratus plane block with saline

Study type: Interventional

Funder types: Other

Identifiers

NCT03615430

[2016]124

Details and patient eligibility

About

A prospective, double-blinded randomized controlled, 1-year follow-up study was designed to compare the analgesic effect of serratus plane block (SPB) after breast cancer surgery. Women undergoing radical mastectomy were dIvided into Control group and SPB group. The postoperative acute pain was evaluated by numerical rating scale (NRS) and the effect of preventing chronic pain was assessed at 3, 6, 12 months after surgery by NRS.

Enrollment: 50 patients

Sex: Female

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• women undergoing radical mastectomy with either sentinel lymph node dissection or axillary lymph node dissection or no axillary lymph node dissection
• between the ages of 18 and 85 yr
• with an American Society of Anesthesiology (ASA) physical status I or II
• without any significant cardiopulmonary, renal and hepatic dysfunction

Exclusion criteria

• Patients with any previous cancer other than breast cancer
• occurrence of allergy to local anesthetics
• occurrence of opioid-tolerant subjects
• occurrence of consuming analgesics, sedatives, antidepressants or any history of substance abuse before surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups, including a placebo group

Control group

Placebo Comparator group

Description:

saline control group, 15 mL of the saline was administered to superficial and deep surface of serratus anterior in Control group via ultrasound before the surgery

Treatment:

Procedure: serratus plane block with saline

SPB group

Experimental group

Description:

Serratus plane block group, 15ml of 0.25% ropivacaine, a widely used local anesthetic for peripheral nerve block, was administered to superficial and deep surface of serratus anterior in SPB group via ultrasound before the surgery

Treatment:

Procedure: serratus plane block with local anesthetic