A Randomized Clinical Trial
- Conditions
- Regional Anesthesia
- Interventions
- Procedure: PECS block
- Registration Number
- NCT03947463
- Lead Sponsor
- Shaukat Khanum Memorial Cancer Hospital & Research Centre
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 120
- Female age 18 or older
- (ASA) I and II
- Scheduled to undergo elective unilateral mastectomy or Modified radical mastectomy (MRM) under general anesthesia.
- Patient's refusal
- history of allergy to bupivacaine
- contraindications to regional anaesthesia (coagulopathy and local infection),
- BMI > 40 kg/m2,
- patient scheduled for bilateral mastectomies
- use of chronic pain medications
- history of illicit drugs or alcohol abuse and history of psychiatric problems.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description PECS block group PECS block 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
- Primary Outcome Measures
Name Time Method Change in Pain score over 24 hours First 24 hrs Patient'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 Outcome Measures
Name Time Method Post operative morphine (opioids) consumption in PACU first 24 hours If 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 PONV 120 minutes The 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
Trial Locations
- Locations (1)
Shaukat Khanum Memorial Cancer Hospital and Research Center
🇵🇰Lahore, Punjab, Pakistan