Clinical trial NCT03947463: A Randomized Clinical Trial
Official title: Pectoral Nerves I, II and Serratus Plane Blocks in Multimodal Analgesia for Mastectomies A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Regional Anesthesia
Keywords: Pectoral Nerves I & II block, Serratus Plane Block, General Anesthesia, opioid analgesia, breast cancer and modified radical mastectomy
Lead sponsor: Shaukat Khanum Memorial Cancer Hospital & Research Centre
Sponsor class: OTHER
First posted: 2019-05-13
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Pain score over 24 hours
timeFrame: First 24 hrs
Secondary outcomes:
measure: Post operative morphine (opioids) consumption in PACU
timeFrame: first 24 hours
measure: Antiemetic consumption for treatment of PONV
timeFrame: 120 minutes
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Shaukat Khanum Memorial Cancer Hospital and Research Center
state: Punjab
Study officials:
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