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

NCT04317898 | Unknown

• 1 other identifier: analgesia in chronic PMPs
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Post-mastectomy Pain Syndrome

Outcome Measures

Primary Outcomes (1)

• Percentage of patients gaining ≥ 50% pain reduction at VAS Score from baseline value.

  Compare the analgesic efficacy between ultrasound paraverbral block and serratus block in chronic postmastectomy pain.

  baseline

Study Arms (2)

serratus plane block

ACTIVE COMPARATOR

20 ml of Bupivacine 0.25% +80mg triamcinlone will be injected in serratus plane under ultrasound.

Procedure: serratus plane block by ultra-sound

paravertebral block

ACTIVE COMPARATOR

10 ml of bubivacine 0.25% +80 mg triamcinlone will be injected at T2 level (paravertebral) under ultrasound.

Procedure: paravertebral block by ultra-sound

Interventions

serratus plane block by ultra-sound PROCEDURE

To perform Serratus block, patients will be placed in the lateral decubitus position with the affected side facing up, or in the prone position with the affected side facing the operator . After sterile preparation, a linear ultrasound probe will be utilized to identify the latissimusdorsi and serratus anterior muscles in a sagittal plane. The plane superficial to the serratus anterior muscle and below the latissimusdorsi muscle will be identified. The skin will be topicalized with 1 mL of 1% lidocaine using a 30-gauge needle. Using an in-plane approach, a 25-gauge 1.5-cm needle will be used to inject a total of 20-mL of 0.25% bupivacaine with 80 mg of triamcinlone under direct ultrasound visualization.

serratus plane block

paravertebral block by ultra-sound PROCEDURE

TPVB will be given using high frequency linear US transducer, place the probe parallel to the vertebral spine at T2 level and shifted 2-3 cm laterally to obtain the appropriate visualization. Following the identification of plura, transverse process and paravertebral space, the needle will be inserted in caudocranial direction using in-plane approach. Confirm negative vessel or pleural breach via aspiration then proceed with local anaesthetic 10ml of 0.25% bubivacine and 80mg triamcinlone slowly; the pleura will be seen to be pushed downward.

paravertebral block

Eligibility Criteria

• Age: 18 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients have postmastectomy pain of neuropathic nature, DN4
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (6)

• Gartner R, Jensen MB, Nielsen J, Ewertz M, Kroman N, Kehlet H. Prevalence of and factors associated with persistent pain following breast cancer surgery. JAMA. 2009 Nov 11;302(18):1985-92. doi: 10.1001/jama.2009.1568.

  PMID: 19903919 BACKGROUND

• Smith WC, Bourne D, Squair J, Phillips DO, Chambers WA. A retrospective cohort study of post mastectomy pain syndrome. Pain. 1999 Oct;83(1):91-5. doi: 10.1016/s0304-3959(99)00076-7.

  PMID: 10506676 BACKGROUND

• Couceiro TC, Menezes TC, Valenca MM. Post-mastectomy pain syndrome: the magnitude of the problem. Rev Bras Anestesiol. 2009 May-Jun;59(3):358-65. doi: 10.1590/s0034-70942009000300012. English, Portuguese.

  PMID: 19488550 BACKGROUND

• Peuckmann V, Ekholm O, Rasmussen NK, Groenvold M, Christiansen P, Moller S, Eriksen J, Sjogren P. Chronic pain and other sequelae in long-term breast cancer survivors: nationwide survey in Denmark. Eur J Pain. 2009 May;13(5):478-85. doi: 10.1016/j.ejpain.2008.05.015. Epub 2008 Jul 16.

  PMID: 18635381 BACKGROUND

• Fernandez-Lao C, Cantarero-Villanueva I, Fernandez-de-Las-Penas C, del Moral-Avila R, Castro-Sanchez AM, Arroyo-Morales M. Effectiveness of a multidimensional physical therapy program on pain, pressure hypersensitivity, and trigger points in breast cancer survivors: a randomized controlled clinical trial. Clin J Pain. 2012 Feb;28(2):113-21. doi: 10.1097/AJP.0b013e318225dc02.

  PMID: 21705873 BACKGROUND

• Wijayasinghe N, Andersen KG, Kehlet H. Neural blockade for persistent pain after breast cancer surgery. Reg Anesth Pain Med. 2014 Jul-Aug;39(4):272-8. doi: 10.1097/AAP.0000000000000101.

  PMID: 24918332 BACKGROUND

Study Officials

• Mohammed Mohammed Abd El-Latif, Prof of Anesthesia

  Mohammed MohammedAbd El-Latif

  STUDY DIRECTOR

• Ashraf Amin Mohammed, Prof of Anesthesia

  Ashraf Amin Mohammed

  STUDY DIRECTOR

• Rania Mohammed Abd El-Emam, Lecturer of Anesthesia

  Rania Mohammed Abd El-Emam

  STUDY DIRECTOR

Central Study Contacts

Aya Abo Eldahab Ali Eldein, Resident

CONTACT

01068744428; totaaboeldahab8@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: March 20, 2020
• First Posted: March 23, 2020
• Study Start: July 1, 2020
• Primary Completion: April 1, 2021
• Study Completion: June 1, 2021
• Last Updated: July 15, 2020

Record last verified: 2020-07