A Randomized Clinical Trial

NCT03947463 | Completed

• 1 other identifier: IRB-15-03
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Regional Anesthesia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in Pain score over 24 hours

  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.

  First 24 hrs

Secondary Outcomes (2)

• Post operative morphine (opioids) consumption in PACU

  first 24 hours

• Antiemetic consumption for treatment of PONV

  120 minutes

Study Arms (2)

PECS block group

EXPERIMENTAL

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

Procedure: PECS block

Control group

NO INTERVENTION

Patient were given multimodal analgesia without the regional block

Interventions

PECS block PROCEDURE

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.

PECS block group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female patient's diagnosed with breast cancer, undergoing mastectomy
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shaukat Khanum Memorial Cancer Hospital & Research Centre: lead

Study Sites (1)

Shaukat Khanum Memorial Cancer Hospital and Research Center

Lahore, Punjab Province, Pakistan

Location

Related Publications (20)

• Menhas R, Umer S. Breast Cancer among Pakistani Women. Iran J Public Health. 2015 Apr;44(4):586-7. No abstract available.

  PMID: 26056679 BACKGROUND

• Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 1;136(5):E359-86. doi: 10.1002/ijc.29210. Epub 2014 Oct 9.

  PMID: 25220842 BACKGROUND

• Andersen KG, Duriaud HM, Jensen HE, Kroman N, Kehlet H. Predictive factors for the development of persistent pain after breast cancer surgery. Pain. 2015 Dec;156(12):2413-2422. doi: 10.1097/j.pain.0000000000000298.

  PMID: 26176893 BACKGROUND

• Afonso AM, Newman MI, Seeley N, Hutchins J, Smith KL, Mena G, Selber JC, Saint-Cyr MH, Gadsden JC. Multimodal Analgesia in Breast Surgical Procedures: Technical and Pharmacological Considerations for Liposomal Bupivacaine Use. Plast Reconstr Surg Glob Open. 2017 Sep 15;5(9):e1480. doi: 10.1097/GOX.0000000000001480. eCollection 2017 Sep.

  PMID: 29062649 BACKGROUND

• Richebe P, Rivat C, Liu SS. Perioperative or postoperative nerve block for preventive analgesia: should we care about the timing of our regional anesthesia? Anesth Analg. 2013 May;116(5):969-970. doi: 10.1213/ANE.0b013e31828843c9. No abstract available.

  PMID: 23606468 BACKGROUND

• Gurkan Y, Aksu C, Kus A, Yorukoglu UH, Kilic CT. Ultrasound guided erector spinae plane block reduces postoperative opioid consumption following breast surgery: A randomized controlled study. J Clin Anesth. 2018 Nov;50:65-68. doi: 10.1016/j.jclinane.2018.06.033. Epub 2018 Jul 2.

  PMID: 29980005 BACKGROUND

• Syal K, Chandel A. Comparison of the post-operative analgesic effect of paravertebral block, pectoral nerve block and local infiltration in patients undergoing modified radical mastectomy: A randomised double-blind trial. Indian J Anaesth. 2017 Aug;61(8):643-648. doi: 10.4103/ija.IJA_81_17.

  PMID: 28890559 BACKGROUND

• Blanco R. The 'pecs block': a novel technique for providing analgesia after breast surgery. Anaesthesia. 2011 Sep;66(9):847-8. doi: 10.1111/j.1365-2044.2011.06838.x. No abstract available.

  PMID: 21831090 BACKGROUND

• Blanco R, Fajardo M, Parras Maldonado T. Ultrasound description of Pecs II (modified Pecs I): a novel approach to breast surgery. Rev Esp Anestesiol Reanim. 2012 Nov;59(9):470-5. doi: 10.1016/j.redar.2012.07.003. Epub 2012 Aug 29.

  PMID: 22939099 BACKGROUND

• Porzionato A, Macchi V, Stecco C, Loukas M, Tubbs RS, De Caro R. Surgical anatomy of the pectoral nerves and the pectoral musculature. Clin Anat. 2012 Jul;25(5):559-75. doi: 10.1002/ca.21301. Epub 2011 Nov 28.

  PMID: 22125052 BACKGROUND

• Ullah H, Samad K, Khan FA. Continuous interscalene brachial plexus block versus parenteral analgesia for postoperative pain relief after major shoulder surgery. Cochrane Database Syst Rev. 2014 Feb 4;2014(2):CD007080. doi: 10.1002/14651858.CD007080.pub2.

  PMID: 24492959 BACKGROUND

• Akram M, Farooqi FM, Irshad M, Faraz Ul Hassan S, Awais SM. Role of addition of Dexamethasone and Ketorolac to lignocaine intravenous regional anesthesia (Bier's Block) to improve tourniquet tolerance and post-operative analgesia in hand and forearm surgery. J Pak Med Assoc. 2015 Nov;65(11 Suppl 3):S128-31.

  PMID: 26878503 BACKGROUND

• Shah AA, Rasool A, Alam MA, Naseem Y, Rasool M, Hussain A, Jadoon S, Shah EH, Malik AA, Ahmed N; Salahudin. Efficacy Of Phenylephrine Infusion Verses Colloid Preloading In Resolving Hypotension Due To Spinal Anaesthesia During Caesarean Section. J Ayub Med Coll Abbottabad. 2018 Jul-Sep;30(3):377-380.

  PMID: 30465369 BACKGROUND

• Thomas M, Philip FA, Mathew AP, Jagathnath Krishna KM. Intraoperative pectoral nerve block (Pec) for breast cancer surgery: A randomized controlled trial. J Anaesthesiol Clin Pharmacol. 2018 Jul-Sep;34(3):318-323. doi: 10.4103/joacp.JOACP_191_17.

  PMID: 30386013 BACKGROUND

• Madabushi R, Tewari S, Gautam SK, Agarwal A, Agarwal A. Serratus anterior plane block: a new analgesic technique for post-thoracotomy pain. Pain Physician. 2015 May-Jun;18(3):E421-4.

  PMID: 26000690 BACKGROUND

• Tighe SQ, Karmakar MK. Serratus plane block: do we need to learn another technique for thoracic wall blockade? Anaesthesia. 2013 Nov;68(11):1103-6. doi: 10.1111/anae.12423. Epub 2013 Sep 14. No abstract available.

  PMID: 24032664 BACKGROUND

• Naja MZ, Ziade MF, Lonnqvist PA. Nerve-stimulator guided paravertebral blockade vs. general anaesthesia for breast surgery: a prospective randomized trial. Eur J Anaesthesiol. 2003 Nov;20(11):897-903. doi: 10.1017/s0265021503001443.

  PMID: 14649342 BACKGROUND

• Terheggen MA, Wille F, Borel Rinkes IH, Ionescu TI, Knape JT. Paravertebral blockade for minor breast surgery. Anesth Analg. 2002 Feb;94(2):355-9, table of contents. doi: 10.1097/00000539-200202000-00023.

  PMID: 11812698 BACKGROUND

• Coveney E, Weltz CR, Greengrass R, Iglehart JD, Leight GS, Steele SM, Lyerly HK. Use of paravertebral block anesthesia in the surgical management of breast cancer: experience in 156 cases. Ann Surg. 1998 Apr;227(4):496-501. doi: 10.1097/00000658-199804000-00008.

  PMID: 9563536 BACKGROUND

• Lonnqvist PA, MacKenzie J, Soni AK, Conacher ID. Paravertebral blockade. Failure rate and complications. Anaesthesia. 1995 Sep;50(9):813-5. doi: 10.1111/j.1365-2044.1995.tb06148.x.

  PMID: 7573876 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Registered pain nurse
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow in Anesthesia

Study Record Dates

• First Submitted: April 24, 2019
• First Posted: May 13, 2019
• Study Start: February 1, 2017
• Primary Completion: December 19, 2017
• Study Completion: March 1, 2018
• Last Updated: May 13, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)