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

NCT ID: NCT03653988

Last Updated: 2024-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-12
• Study Completion Date: 2021-10-31

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.

Detailed Description

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. The investigators will compare whether patients will have better pain control if they were to receive (PEC I/II block) before surgery or after the mastectomy. Patients undergoing mastectomies at the University of Iowa Hospitals clinics receive general anesthesia and a regional block for pain control. The most commonly employed regional anesthetic technique is a PECS I/II block to anesthetize the pectoral, intercostobrachial, third to sixth intercostal and long thoracic nerves. The PECS 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 (PECS II). The investigators will randomize patients into two groups and blind the patient and the research assistant collecting the data. Group I will have the block performed after induction of general anesthesia and prior to surgical incision by the anesthesiologist. Group II will have the block administered by the surgeon after mastectomy is performed and before reconstruction. On the day of surgery, the investigators will have patients fill out forms to measure pain catastrophizing and depression and anxiety. The investigators would like to measure if there is any difference in postoperative pain scores (visual analogue scale)-immediately post surgery in post-anesthesia care unit (PACU), and then on the admission unit every 4 hours for the first twenty four hours or on discharge (whichever time-point occurs sooner) and will collect the average pain scale of the day on post-op day (POD) 2,3,5 and 7 via patient communication electronic message in RedCap. The investigators will also measure intraoperative and post-operative narcotic use (converted to morphine equivalents), post-operative nausea and vomiting, length of (PACU) stay. In addition the investigators will also collect pain scores and pain catastrophic scale on POD 14 after surgery at their clinic visits to the surgeon. Other data collected will include time taken to perform block, post-operative infection rate and post-operative flap necrosis rate.

Conditions

Breast Cancer; Postoperative Pain; Anesthesia; Nerve Block

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

PEC I/II block - pre-operative

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.

Group Type: ACTIVE_COMPARATOR

PEC I/II blocks by anesthesiologist - pre-operative

Intervention Type: 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 - intra-operative

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.

Group Type: EXPERIMENTAL

PEC I/II blocks by surgeon - intra-operative

Intervention Type: 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).

Interventions

PEC I/II blocks by anesthesiologist - pre-operative

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.

Intervention Type: PROCEDURE

PEC I/II blocks by surgeon - intra-operative

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).

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Melinda Seering

OTHER

Sponsor Role: lead

Responsible Party

Melinda Seering

Principle Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Melinda Seering, MD

Role: PRINCIPAL_INVESTIGATOR

Univerisity of Iowa Hospital & Clinics

Ingrid Lizarraga, MD

Role: PRINCIPAL_INVESTIGATOR

Univerisity of Iowa Hospital & Clinics

Locations

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Countries

United States

References

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Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

201805930

Identifier Type: -

Identifier Source: org_study_id