RecruitingACTRN12616001396415

Comparison of two ultrasound guided nerve blocks in patients undergoing breast surgery: effects on post-surgery pain.

Comparison of analgesic efficacy of Ultrasound guided Paravertebral block and Serratus Anterior Plane block in patients undergoing Modified Radical Mastectomy


Sponsor

safdarjung hospital

Enrollment

50 participants

Start Date

Sep 1, 2016

Study Type

Interventional

Conditions

Summary

Introduction: Modified Radical Mastectomy (MRM) may be associated with severe post-operative pain, leading to impairment of respiratory gas exchange or chronic pain syndrome. We will compare the analgesic efficacy and safety profile of two new and promising ultrasound guided nerve blocks: paravertebral block and serratus anterior plane block for these surgeries. Methods: This study will be conducted on 50 adult females,scheduled for Modified Radical Mastectomy. After inducing general anesthesia,patients will be given either ultrasound guided paravertebral block (n=25) or serratus anterior plane block (n=25) with 20 ml of 0.5% bupivacaine to freeze the nerves. After completion of surgery, patient will be monitored in recovery for adequate pain relief and any adverse effects of the block. Patient will be attached to a I.V.PCA pump for morphine administration, whenever she has pain. The resident will assess the adequacy of pain relief and any side effects at regular intervals.


Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 65 Yearss

Plain Language Summary

Simplified for easier understanding

This study is comparing two types of nerve block injections — guided by ultrasound — to see which provides better pain relief after breast cancer surgery (modified radical mastectomy). The two approaches being compared are a paravertebral block (near the spine) and a serratus anterior plane block (along the side of the chest wall). You may be eligible if: - You are a female between 18 and 65 years old - You are scheduled for a modified radical mastectomy (breast and lymph node removal) - You are classified as low to moderate surgical risk (ASA I or II) - You weigh between 40 and 85 kg You may NOT be eligible if: - You have a blood clotting disorder or are on blood thinners - You have a skin infection at the injection site or a recent neurological deficit - You have a known allergy to local anaesthetics - You have significant heart, kidney, liver, or lung conditions Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

In the operation theatre of Safdarjung Hospital, new delhi, general anesthesia will be induced with midazolam 1mg, fentanyl 1.5 mcg/kg, propofol 1- 2 mg/kg and vecuronium bromide 0.1 mg/kg and trachea

In the operation theatre of Safdarjung Hospital, new delhi, general anesthesia will be induced with midazolam 1mg, fentanyl 1.5 mcg/kg, propofol 1- 2 mg/kg and vecuronium bromide 0.1 mg/kg and trachea of the patient will be intubated, Patient will be given either ultrasound guided paravertebral block (n=25) or ultrasound guided serratus anterior plane block (n=25) with 20 ml of 0.5% bupivacaine by a staff anesthesiologist with experience of both the blocks ( more than 50 each). 1. Group SAB:--- Ultrasound guided serratus anterior plane block- This block will be given in supine position. Linear transducer (8-13Mhz) probe of ultrasound machine (Sonosite M-Turbo, Sonosite Inc., USA) will be placed in mid-clavicular region of thoracic cage in the sagittal plane. The latissimus dorsi, teres major and serratus anterior muscles will be identified between 4th and 5th rib. The fascial plane between serratus anterior muscle and latissimus dorsi muscle will be identified. 20 G sonosonic needle will be introduced in-plane with respect to ultrasound probe from superio-anterior to posterio-inferior direction. Under continuous ultrasound guidance, 20ml of 0.5% bupivacaine will be injected superior to the serratus anterior muscle. Group PVB: Ultra sound guided paravertebral block--- This block will be given in the lateral position. The transducer (linear, 38mm, high frequency 8-13MHz) probe of ultrasound machine (Sonosite M-Turbo, Sonosite Inc., USA) will be placed parallel to the spine, above the transverse process of T4 vertebrae and T5 vertebrae. The thoracic paravertebral space will be identified as a wedge shaped hypoechoic space between internal intercostal membrane and pleura. 20 G sonosonic needle will be inserted in an out of plane approach and advanced under ultrasound guidance until the tip penetrates internal intercostal membrane. Hydro-dissection will be used to locate the tip of needle. 20ml of 0.5% bupivacaine will be injected and movement of pleura downwards will be used as confirmation of block. Anesthesia will be maintained with O2/ N2O/ 0.8-1% Isoflurane. At the end of surgery, . Neostigmine 50 mcg/kg and glycopyrrolate 10 mcg/kg will be given I.V. and trachea extubated. Patient is shifted to PACU for intensive monitoring of vitals.A resident blinded to block will assess the pain relief and adverse effects at regular intervals for next 72 hrs.


Locations(1)

delhi, India

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ACTRN12616001396415