NCT02672813

Brief Summary

The primary objective of this study is to access the effect of Pectoral nerve I and II blocks in breast surgery as measured by consumption of postoperative morphine or its equivalent.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 3, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

February 5, 2016

Status Verified

February 1, 2016

Enrollment Period

1 year

First QC Date

January 28, 2016

Last Update Submit

February 4, 2016

Conditions

Pain, Postoperative

Keywords

Pectoral nerve I and II blocksBreast surgeryRopivacainePostoperative opioid consumption

Outcome Measures

Primary Outcomes (1)

  • Postoperative Morphine consumption.

    Total amount of Morphine or its equivalent consumed by the patient in 24 hours following surgery is recorded

    24h

Secondary Outcomes (5)

  • Postoperative Numerical Rating scale (NRS) score for pain

    24 h

  • Satisfaction level

    24h

  • Nausea and Vomiting

    24h

  • Local Anesthetic toxicity

    24h

  • sedation score

    24h

Study Arms (2)

Pectoral Nerve I and II block

EXPERIMENTAL

Under Ultrasound guidance, Pectoral nerve I block is given for every breast surgery using 10ml of 0.25 % Ropivacaine ( without added preservatives). Similarly Pectoral nerve II block is also given using 20 ml of 0.25% Ropivacaine ( without added preservative) in same group of patient.

Procedure: Pectoral nerve I and II block

No block

NO INTERVENTION

Pectoral nerve block is not given in this group of patients undergoing breast surgery

Interventions

Pectoral nerve I and II blockPROCEDURE

Under Ultrasound guidance, Pectoral nerve I and II block is given for every breast surgery by using 10 and 20 ml of 0.25% Ropivacaine respectively

Also known as: Pecs block
Pectoral Nerve I and II block

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anesthesiologist ( ASA) Physical Status I, II
  • Age between 16-65 Years
  • Patients Undergoing breast surgery

You may not qualify if:

  • Patient refusal
  • Local infection
  • Known hypersensitivity or any contraindications to study medication
  • History of chronic pain
  • Psychiatric illness
  • Bilateral breast surgery
  • Weight \< 40 kg and \> 100 kg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BP Koirala Institute of Health Sciences

Dharān, Sunsari, 56700, Nepal

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dental Occlusion

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

DentistryDental Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Officials

  • Krishna Pokharel, MD

    B.P. Koirala Institute of Health Sciences

    STUDY DIRECTOR

Central Study Contacts

Anuranjan Ghimire, MBBS

CONTACT

09779841551123anuranjanghimire2@gmail.com

Krishna Pokharel, MD

CONTACT

09779841986321

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

January 28, 2016

First Posted

February 3, 2016

Study Start

July 1, 2015

Primary Completion

July 1, 2016

Study Completion

September 1, 2016

Last Updated

February 5, 2016

Record last verified: 2016-02

Locations

NE(1)