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A Randomized Clinical Trial

S

Shaukat Khanum Memorial Cancer Hospital & Research Centre

Status

Completed

Conditions

Regional Anesthesia

Treatments

Procedure: PECS block

Study type

Interventional

Funder types

Other

Identifiers

NCT03947463
IRB-15-03

Details and patient eligibility

About

Acute postoperative pain is a common problem faced by the patient after surgery, most frequently occurring in first 24 hours. Our primary objective was to assess pain score in first 24 hours in PECS block group undergoing mastectomies. Secondary objective was to observe morphine (opioids) and antiemetic consumption in post anesthetic care unit.

Full description

Design: Observer Blinded Randomized control trial.

Place and Duration: Department of Anesthesiology, Shaukat Khanum Memorial Cancer Hospital Lahore (SKMCH), from February 2017 to December 2017

Methods: 120 patients more than 18 years, ASA I and II, planned for unilateral elective modified radical mastectomy under general anesthesia were randomly assigned to receive either general anesthesia plus Pectoral Nerve I, II and serratus (PECS) block (n = 60) or general anesthesia alone (n = 60). Pain score at fixed intervals was measured using Numeric Pain Rating Score (NPRS) after surgery.

Enrollment

120 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Female age 18 or older
  • (ASA) I and II
  • Scheduled to undergo elective unilateral mastectomy or Modified radical mastectomy (MRM) under general anesthesia.

Exclusion criteria

  1. Patient's refusal
  2. history of allergy to bupivacaine
  3. contraindications to regional anaesthesia (coagulopathy and local infection),
  4. BMI > 40 kg/m2,
  5. patient scheduled for bilateral mastectomies
  6. use of chronic pain medications
  7. history of illicit drugs or alcohol abuse and history of psychiatric problems.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Single Blind

120 participants in 2 patient groups

PECS block group
Experimental group
Description:
20ml of 0.25% bupivacaine was infiltrated between pectoralis major and pectoralis minor muscle and the spread was visualised on the ultrasound screen. similarly, in Serratus plane block, ultrasound probe was placed over the mid-axillary region of the thoracic cage in a sagittal plane. Ribs were identified inferiorly and laterally, until the identification of the 3rd rib in the mid axillary line. 10 ml of 0.25% bupivacaine was infiltrated in between Serratus anterior muscle and Latissimus Dorsi muscle
Treatment:
Procedure: PECS block
Control group
No Intervention group
Description:
Patient were given multimodal analgesia without the regional block

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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