Comparison of Pre-op and Post-op Pectoralis Nerve Block

NCT03653988 | Completed Results DMC

• 1 other identifier: 201805930
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will compare whether patients will have better pain control if they were to receive (PEC I/II block) before surgery or after mastectomy.

Conditions

Breast Cancer; Postoperative Pain; Anesthesia; Nerve Block

Keywords

Nerve block; Pectoralis nerve blocks; PECS I; PECS II; Mastectomy

Outcome Measures

Primary Outcomes (1)

• Pain Score Assessment Using a Visual Analog Scale-Immediately Post-surgery

  The primary outcome to be assessed is to determine if there is a quantitative difference in post-operative pain scores as a result of the administration of a pre-operative PECS I/II block versus the administration of an intra-operative PECS I/II block (Post mastectomy but prior to breast reconstruction). The visual analog scale is a unidimensional measure of pain used in a diverse adult population. The numeric values are on a continuous scale from 0 to 10 with 0 indicating no pain, 5 being moderate pain and 10 as intense pain.

  upon arrival to the recovery room after leaving the operating room

Secondary Outcomes (7)

• Pain Score Assessment-Post-operative Day 1

  Day 1 post surgery

• Pain Score Assessment-Post-operative Day 3

  Day 3 post surgery

• Pain Score Assessment-Post-operative Day 7

  Day 7 post surgery

• Pain Score Assessment Using a Visual Analog Scale-Post-operative Surgical Recheck.

  Approximately day 14 post surgery

• Measure the Amount of Narcotics Use to Control Pain.

  PACU (from time patient left operating room until patient is discharged from the recovery area to in-patient unit). The time limit for this is generally 60-90 minutes

Study Arms (2)

PEC I/II block - pre-operative

ACTIVE COMPARATOR

The current standard of care at the University of Iowa is to receive a pectoralis nerve block (PEC I/II) prior to surgery for mastectomy and reconstruction case. The intervention administered to Group I will having the block performed by the anesthesiologist after induction of general anesthesia and prior to surgical incision.

Procedure: PEC I/II blocks by anesthesiologist - pre-operative

PEC I/II block - intra-operative

EXPERIMENTAL

The current standard of care at the University of Iowa is to receive a pectoralis nerve block (PEC I/II) prior to surgery for mastectomy and reconstruction cases. Group II will have the block administered by the surgeon after mastectomy is performed and before reconstruction.

Procedure: PEC I/II blocks by surgeon - intra-operative

Interventions

PEC I/II blocks by anesthesiologist - pre-operative PROCEDURE

PEC I/II blocks by anesthesiologist - pre-operative; PEC I/II block to anesthetize the pectoral, intercostobrachial, third to sixth intercostal and long thoracic nerves. The PEC I/II blocks are pectoralis field blocks where local anesthetic medication is injected under ultrasound guidance between the tissue planes of pectoralis major and minor muscles (PECS I) and in the plane of the serratus anterior muscle at the level of the third rib (PEC II). Group I will have the PEC block administered by the anesthesiologist prior to surgical incision.

PEC I/II block - pre-operative

PEC I/II blocks by surgeon - intra-operative PROCEDURE

PEC I/II blocks by surgeon - intra-operative; PEC I/II block to anesthetize the pectoral, intercostobrachial, third to sixth intercostal and long thoracic nerves. The PEC I/II blocks are pectoralis field blocks where local anesthetic medication is injected under ultrasound guidance between the tissue planes of pectoralis major and minor muscles (PECS I) and in the plane of the serratus anterior muscle at the level of the third rib (PEC II).

PEC I/II block - intra-operative

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: Female patients with breast cancer scheduled to undergo mastectomy
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age
• Female
• Bilateral mastectomy for breast cancer
• Undergoing breast reconstruction
• Must weigh at least 50 kg

You may not qualify if:

• More than 80 years of age
• Male
• Prisoners
• Patients who can't provide their own consent
• Lumpectomy only patients
• Patients having prophylactic mastectomies
• Patient must weigh at least 50 kg
• Allergies to local anesthetics
• Patient refusal
• Patients with a history of bleeding disorders
• Non-English speaking patients

Sponsors & Collaborators

• Melinda Seering: lead

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52245, United States

Location

Related Publications (16)

• Bashandy GM, Abbas DN. Pectoral nerves I and II blocks in multimodal analgesia for breast cancer surgery: a randomized clinical trial. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):68-74. doi: 10.1097/AAP.0000000000000163.

  PMID: 25376971 BACKGROUND

• Kamiya Y, Hasegawa M, Yoshida T, Takamatsu M, Koyama Y. Impact of pectoral nerve block on postoperative pain and quality of recovery in patients undergoing breast cancer surgery: A randomised controlled trial. Eur J Anaesthesiol. 2018 Mar;35(3):215-223. doi: 10.1097/EJA.0000000000000762.

  PMID: 29227351 BACKGROUND

• Kulhari S, Bharti N, Bala I, Arora S, Singh G. Efficacy of pectoral nerve block versus thoracic paravertebral block for postoperative analgesia after radical mastectomy: a randomized controlled trial. Br J Anaesth. 2016 Sep;117(3):382-6. doi: 10.1093/bja/aew223.

  PMID: 27543533 BACKGROUND

• Larsson IM, Ahm Sorensen J, Bille C. The Post-mastectomy Pain Syndrome-A Systematic Review of the Treatment Modalities. Breast J. 2017 May;23(3):338-343. doi: 10.1111/tbj.12739. Epub 2017 Jan 30.

  PMID: 28133848 BACKGROUND

• Ruscheweyh R, Viehoff A, Tio J, Pogatzki-Zahn EM. Psychophysical and psychological predictors of acute pain after breast surgery differ in patients with and without pre-existing chronic pain. Pain. 2017 Jun;158(6):1030-1038. doi: 10.1097/j.pain.0000000000000873.

  PMID: 28195858 BACKGROUND

• Schreiber KL, Kehlet H, Belfer I, Edwards RR. Predicting, preventing and managing persistent pain after breast cancer surgery: the importance of psychosocial factors. Pain Manag. 2014;4(6):445-59. doi: 10.2217/pmt.14.33.

  PMID: 25494696 BACKGROUND

• Schreiber KL, Martel MO, Shnol H, Shaffer JR, Greco C, Viray N, Taylor LN, McLaughlin M, Brufsky A, Ahrendt G, Bovbjerg D, Edwards RR, Belfer I. Persistent pain in postmastectomy patients: comparison of psychophysical, medical, surgical, and psychosocial characteristics between patients with and without pain. Pain. 2013 May;154(5):660-668. doi: 10.1016/j.pain.2012.11.015. Epub 2012 Dec 5.

  PMID: 23290256 BACKGROUND

• Vadivelu N, Schreck M, Lopez J, Kodumudi G, Narayan D. Pain after mastectomy and breast reconstruction. Am Surg. 2008 Apr;74(4):285-96.

  PMID: 18453290 BACKGROUND

• Vilholm OJ, Cold S, Rasmussen L, Sindrup SH. The postmastectomy pain syndrome: an epidemiological study on the prevalence of chronic pain after surgery for breast cancer. Br J Cancer. 2008 Aug 19;99(4):604-10. doi: 10.1038/sj.bjc.6604534.

  PMID: 18682712 BACKGROUND

• Wallace MS, Wallace AM, Lee J, Dobke MK. Pain after breast surgery: a survey of 282 women. Pain. 1996 Aug;66(2-3):195-205. doi: 10.1016/0304-3959(96)03064-3.

  PMID: 8880841 BACKGROUND

• Wang L, Guyatt GH, Kennedy SA, Romerosa B, Kwon HY, Kaushal A, Chang Y, Craigie S, de Almeida CPB, Couban RJ, Parascandalo SR, Izhar Z, Reid S, Khan JS, McGillion M, Busse JW. Predictors of persistent pain after breast cancer surgery: a systematic review and meta-analysis of observational studies. CMAJ. 2016 Oct 4;188(14):E352-E361. doi: 10.1503/cmaj.151276. Epub 2016 Jul 11.

  PMID: 27402075 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

• Kairaluoma PM, Bachmann MS, Rosenberg PH, Pere PJ. Preincisional paravertebral block reduces the prevalence of chronic pain after breast surgery. Anesth Analg. 2006 Sep;103(3):703-8. doi: 10.1213/01.ane.0000230603.92574.4e.

  PMID: 16931684 BACKGROUND

• Gartner R, Jensen MB, Nielsen J, Ewertz M, Kroman N, Kehlet H. Prevalence of and factors associated with persistent pain following breast cancer surgery. JAMA. 2009 Nov 11;302(18):1985-92. doi: 10.1001/jama.2009.1568.

  PMID: 19903919 BACKGROUND

• Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available.

  PMID: 22588748 BACKGROUND

• Lizarraga IM, Huang K, Yalamuru B, Mott SL, Sibenaller ZA, Keith JN, Sugg SL, Erdahl LM, Seering M. A Randomized Single-Blinded Study Comparing Preoperative with Post-Mastectomy PECS Block for Post-operative Pain Management in Bilateral Mastectomy with Immediate Reconstruction. Ann Surg Oncol. 2023 Oct;30(10):6010-6021. doi: 10.1245/s10434-023-13890-w. Epub 2023 Aug 1.

  PMID: 37526752 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Pain, Postoperative

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Limitations and Caveats

Tools for measuring postoperative pain are subjective. Among the 23 patients who used the electronic reporting format, 58% of the POD 1-14 questionnaires were completed at least one day later, which raises the concern for recall bias. Secondly, our sample size was calculated to detect a difference in mean pain score of 2; however, given the relatively low mean pain scores encountered in our study, this might not be realistic to achieve.

Results Point of Contact

• Title: Melinda Seering, M.D.
• Organization: University of Iowa Hospitals and Clinics

melinda-seering@uiowa.edu

(319) 384-8466

Study Officials

• Melinda Seering, MD

  Univerisity of Iowa Hospital & Clinics

  PRINCIPAL INVESTIGATOR

• Ingrid Lizarraga, MD

  Univerisity of Iowa Hospital & Clinics

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle Investigator

Model Details: RANDOMIZED CONTROLLED DOUBLE BLIND STUDY

Study Record Dates

• First Submitted: August 14, 2018
• First Posted: August 31, 2018
• Study Start: March 12, 2019
• Primary Completion: October 31, 2021
• Study Completion: October 31, 2021
• Last Updated: August 16, 2024
• Results First Posted: August 16, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: IPD will be available for sharing immediately after publication and ending 5 years following article publication.
• Access Criteria: IPD will be accessible to researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal

Locations

US (1)