Ultrasound-Guided Serratus Plane Block Vs Paravertebral Block For Chronic Post-mastectomy Pain.

Not Applicable

• Conditions: Post-mastectomy Pain Syndrome
• Interventions: Procedure: serratus plane block by ultra-sound; Procedure: paravertebral block by ultra-sound

• Registration Number: NCT04317898
• Lead Sponsor: Assiut University

Brief Summary

compare the analgesic efficacy between ultrasound paraverbral block and serratus block in post mastectomy pain.

Detailed Description

It is reported that postmastectomy pain syndrome (PMPS) is a common problem, ranging from 25% to 60%.

The pain is localized in the axilla, medial upper arm, breast, and/or chest wall and lasting beyond three months after surgery when all other causes of pain such as infection have been eliminated.

The pain seriously affects the patient's mood, everyday activities, and social function and causes heavy economic burden for the healthcare system.

Postmastectomy pain syndrome (PMPS) itself is not a specific diagnosis but rather describes a cluster of symptoms frequently observed in breast cancer survivors following treatment.

Many patients will experience short-term nociceptive pain after breast cancer treatment. However, with PMPS, patients frequently experience persistent neuropathic-type pain: burning, tingling, aching, a subjective sense of "tightness" around the chest wall, or even phantom breast or nipple pain. Neuropathic pain results from dysfunction of the peripheral nerves caused by surgery, radiation, or neurotoxic chemotherapies.

Currently, there are a wide variety of approaches to treat this type of pain. physical therapy has been employed as a modality to improve physical function.

As far as interventional procedures, intercostal nerve blockade, stellate ganglion blockade, and paravertebral blockade have all been utilized with varying degrees of success.

Paraverberal blocks have superseded thoracic epidurals when it comes to choice of a regional anaesthesia technique to provide analgesia for breast surgery.

The injection of local anaesthetic solution in the paravertebral space results in a unilateral block, which is sensory, motor, and sympathetic. The uptake of the local anaesthetic solution is enhanced due to the absence of fascial sheaths binding the spinal nerves.

Another potential target for an interventional procedure for chronic pain after treatment for breast cancer is the serratus plane. The serratus plane block is a novel ultrasound-guided nerve block, which is able to anesthetize the hemithorax.

The serratus plane block relies on the fact that there are branches of the intercostal nerves following within 2 potential spaces, one superficial and one deep, surrounding the serratus anterior muscle. The serratus anterior muscle arises as strips from the first 9 ribs and converges posteriorly on the scapula to form the medial wall of the axilla.

The innervation of the serratus anterior muscle is via the long thoracic nerve (Bell's nerve), and the nerve itself is covered by the fascia of the serratus anterior muscle and lies anterior to the muscle.

Study Timeline

• Study First Submitted: 2020-03-20
• Study First Submitted QC: 2020-03-20
• Study First Posted: 2020-03-23
• Status Verified: 2020-07
• Study Start: 2020-07
• Last Update Submitted: 2020-07-14
• Last Update Posted: 2020-07-15
• Primary Completion: 2021-04
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• Patients have postmastectomy pain of neuropathic nature, DN4

  • 4 for at least 3ms duration.

• The intensity of postmastectomy pain on VAS score ≥ 5.

• Unsatisfactory treatment with 1st line antineuropathic drugs, Pregabalin(150 mg daily) or Deloxetine(60mg daily).

Exclusion Criteria

• Infection of the skin at or near site of needle puncture.
• Coagulopathy .
• Drug hypersensitivity or allergy to the studied drugs.
• Central or peripheral neuropthy .
• Significant organ dysfunction .
• Morbid obesity (BMI>35kg/m2) .
• Vertebral anomalies.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
serratus plane block	serratus plane block by ultra-sound	20 ml of Bupivacine 0.25% +80mg triamcinlone will be injected in serratus plane under ultrasound.
paravertebral block	paravertebral block by ultra-sound	10 ml of bubivacine 0.25% +80 mg triamcinlone will be injected at T2 level (paravertebral) under ultrasound.

Primary Outcome Measures

Name	Time	Method
Percentage of patients gaining ≥ 50% pain reduction at VAS Score from baseline value.	baseline	Compare the analgesic efficacy between ultrasound paraverbral block and serratus block in chronic postmastectomy pain.