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

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12616001396415
• Date of registration: 07/10/2016
• Prospective Registration: No
• Primary sponsor: safdarjung hospital
• Public title: Comparison of two ultrasound guided nerve blocks in patients undergoing breast surgery: effects on post-surgery pain.
• Scientific title: Comparison of analgesic efficacy of Ultrasound guided Paravertebral block and Serratus Anterior Plane block in patients undergoing Modified Radical Mastectomy
• Date of first enrolment: 01/09/2016
• Target sample size: 50
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12616001396415.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);

Countries of recruitment

India

Contacts

• Name: A/Prof dr kapil gupta

• Name: A/Prof dr kapil gupta

Key inclusion & exclusion criteria

Inclusion criteria: . Female patients aged 18-65 years, who are scheduled to undergo Modified Radical Mastectomy, with ASA physical status I and II and weighing 40-85 kgs.


Exclusion criteria: 1. Contraindications to block (e.g. patient with coagulopathy or taking anticoagulant medication and local infection at the site of block) or recent neurological deficit.
2. Known allergy to local anesthestic.
3. Cardiac, renal, hepatic or respiratory insufficiency.


Age minimum: 18 Years
Age maximum: 65 Years
Gender: Females

Health Condition(s) or Problem(s) studied

Cancer - Breast

pain after breast surgery;breast surgery;
pain after breast surgery
breast surgery

Anaesthesiology - Anaesthetics

Anaesthesiology - Pain management

Intervention(s)

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 u

Primary Outcome(s)

Duration of the block- Patient will be instructed to note the first time she uses PCA pump for pain relief on a patient diary. That will be rescue analgesia time [Rescue analgesia time- Time between the administration of block to the first use of the PCA pump by the patient will be recorded as the duration of analgesia of the block]

Primary outcome is post-operative morphine consumption in first 24 hrs post surgery. All observations intra-operatively and post-operatively will be made by a resident, who will be blinded to the type of block given to patient. .Postoperative analgesia will be provided using Patient Controlled Analgesia pump (PCA- T34L, Caesarea Medical Electronics, Israel), attached to the patient in the immediate post operative period. The pump settings will be – morphine- 1 mg/ml; bolus dose 1mg, lock out time 15 mins and maximum dose allowed will be 4mg/hr. Patient will be instructed to use PCA pump whenever she has pain with VAS score greater than 4. PCA pump has a memory that stores the morphine administered to patient[The amount of morphine administered to the patient in first 24hrs post-surgery by PCA pump will be recorded by the resident.]

Secondary Outcome(s)

Pain will be assessed by the patients themselves using self rating VAS ranging from 0 (pain free) to 10 (worst imaginable pain). This VAS score will be explained to the patient before surgery. [VAS score will be assessed at 4 hrs, 6hrs, 24 hrs, 48 hrs and 72 hrs after block administration and recorded by the resident, who is blinded to the study]

morphine consumption by patient in first 48 hrs and 72 hrs postsurgery using the PCA pump will be recorded as secondary outcome[The amount of morphine administered to the patient in first 48hrs and 72 hrs post-surgery by PCA pump will be recorded by the resident.]

Resident will assess the patient for any adverse effects like nausea, vomiting, respiratory problem and itching. [assessment for any adverse effects like nausea, vomiting, respiratory problem and itching will be done at 4 hrs, 6 hrs, 24 hrs, 48 hrs and 72 hrs. ]

Secondary ID(s)

nil known

Source(s) of Monetary Support

safdarjung hospital

Ethics review

Status: Approved
Approval date:
Contact:

vardhaman mahavir medical college & safdarjung hospital ethics committee