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A Randomized Clinical Trial

Pectoral Nerves I, II and Serratus Plane Blocks in Multimodal Analgesia for Mastectomies A Randomized Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03947463
Enrollment
120
Registered
2019-05-13
Start date
2017-02-01
Completion date
2018-03-01
Last updated
2019-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Regional Anesthesia

Keywords

Pectoral Nerves I & II block, Serratus Plane Block, General Anesthesia, opioid analgesia, breast cancer and modified radical mastectomy

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.

Interventions

PROCEDUREPECS block

After the induction of general anesthesia, PECS block was administered patients via ultrasound guided technique. We used Mindray M7 Portable ultrasound system using linear probe with (5-10 MHz) frequency. After cleaning the infra clavicular and axillary region with 2% chlorhexidine in 70% Alcohol solution, ultrasound probe was placed in the infraclavicular region and pectoral major and minor were identified. After identification of the landmarks, 20 gauge 50mm Visoplex needle was inserted in-plane direction. 20ml of 0.25% bupivacaine (within the safe limit of its dose) was infiltrated between pectoralis major and pectoralis minor muscle and the spread was visualized on the ultrasound screen.

Sponsors

Shaukat Khanum Memorial Cancer Hospital & Research Centre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Registered pain nurse

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Pain score over 24 hoursFirst 24 hrsPatient's pain intensity was assessed using NPRS (Numeric Pain scoring system). Pain score was assessed at the time of arrival at PACU (0 minute) and then at 30 minutes after surgery and at discharge from PACU. Pain score was then assessed at the surgical floor at 6hours, 12hours and 24hours.

Secondary

MeasureTime frameDescription
Post operative morphine (opioids) consumption in PACUfirst 24 hoursIf the NPRS score was 3 or more, rescue analgesic dose of 1.5 mg of morphine was administered slowly through the IV route and the pain score was reassessed after 15 minutes. If the pain score was still more than 3, additional dose of 1.5 mg morphine was given. This cycle continued till pain resolved.
Antiemetic consumption for treatment of PONV120 minutesThe incidence of PONV was assessed using a 5-point scale (4-0), where 4 was equivalent to vomiting more than once, 3 was equivalent to one episode of vomit, 2 was equivalent to severe nausea, 1 was equivalent to mild nausea and 0 being no nausea. If the PONV score was more than 2, ondansetron 2 mg IV was administered to treat nausea and vomiting

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026