Block REducing Pain After Surgery Trial

Completed

• Conditions: Chronic Pain Post-Procedural
• Interventions: Procedure: PECS block

• Registration Number: NCT03448913
• Lead Sponsor: University of Padova

Brief Summary

This observational study evaluates difference in chronic pain after six months from surgery between patients who received PECS block and general anesthesia versus general anesthesia alone.

Detailed Description

PECS block is used as a pain relief technique during breast surgery. However at the actual state of knowledge there is no strong evidence that its use could lower incidence of chronic pain compared to general anesthesia alone.

Moreover for its use an adequate skill with ultrasound machine is required. For this reason only some anesthesiologists in our reality use this technique it in clinical practice.

Study Timeline

• Study Start: 2018-02-01
• Study First Submitted: 2018-02-19
• Study First Submitted QC: 2018-02-27
• Study First Posted: 2018-02-28
• Status Verified: 2019-03
• Primary Completion: 2019-03-01
• Study Completion: 2019-03-01
• Last Update Submitted: 2019-03-10
• Last Update Posted: 2019-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• programmed breast surgery
• informed consent

Exclusion Criteria

• bilateral breast surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PECS block+ General anesthesia	PECS block	Patients undergoing mastectomy, partial mastectomy and/or axillary clearance who received PECS block AND general anesthesia for the surgery.

Primary Outcome Measures

Name	Time	Method
Chronic pain at six months	six months	Presence of chronic pain at six months after surgery. For this purpose patient will be asked to report presence of pain on breast, neck, axilla or arm. If patient will report pain a further question about intensity (NRS) and quality (we will ask to patient to describe with words from one to three the pain). Furthermore we will ask to patient if he had take any action (eg drugs) to treat pain

Secondary Outcome Measures

Name	Time	Method
Difference in pain in the first 24 hours after surgery	first 24 hours after surgery	maximum and mean NRS score in the first 24 hours after surgery
Chronic pain at nine months	nine months	Presence of chronic pain at nine months after surgery. For this purpose patient will be asked to report presence of pain on breast, neck, axilla or arm. If patient will report pain a further question about intensity (NRS) and quality (we will ask to patient to describe with words from one to three the pain). Furthermore we will ask to patient if he had take any action (eg drugs) to treat pain
Chronic pain at twelve months	twelve months	Presence of chronic pain at twelve months after surgery. For this purpose patient will be asked to report presence of pain on breast, neck, axilla or arm. If patient will report pain a further question about intensity (NRS) and quality (we will ask to patient to describe with words from one to three the pain). Furthermore we will ask to patient if he had take any action (eg drugs) to treat pain
Chronic pain at three months	three months	Presence of chronic pain at three months after surgery. For this purpose patient will be asked to report presence of pain on breast, neck, axilla or arm. If patient will report pain a further question about intensity (NRS) and quality (we will ask to patient to describe with words from one to three the pain). Furthermore we will ask to patient if he had take any action (eg drugs) to treat pain
Difference in opioid consumption during surgery	day of surgery	Difference in opioid consumption during surgery (Fentanyl as mcg/kg/h; Remifentanil as mcg/kg/min)

Trial Locations

Locations (1)

University of Padova; 🇮🇹 Padova, Italy