A Study to Reduce Persistent Post-mastectomy Pain Using Opioid-free Anesthesia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age19-80
SponsorGangnam Severance Hospital
About this trial
In 230 patients undergoing mastectomy, the investigators will compare opioid-free anesthesia (OFA) versus conventional opioid-based anesthesia in terms of chronic pain. The enrolled patients will be randomly assigned into two groups with 1:1 ratio. Chronic pain will be evaluated at 1 year after mastectomy based on the Breast Cancer Pain Questionnaire (BCPQ). Baseline pain sensitivity test and psychologic evaluation will be done before operation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All of patients will undergo mastectomy with or without immediate breast reconstruction.
Disqualifiers
Previous history of breast surgery
Allergy to drug
Other cancer history
Underlying psychologic disorder
Trial design
Design model
Parallel
Treatments tested in this trial
Opioid-free anesthesia
Procedure/SurgeryOFA group will be sedated using dexmedetomidine and lidocaine.
Conventional opioid-based anesthesia
Procedure/SurgeryConventional opioid-based anesthesia group will be sedated using remi-fentanyl
Treatment groups
230 Participants
are divided into 2 treatment groupsGroup A: Opioid-free anesthesia groupActive comparator 1 intervention
Group B: Conventional anesthesia group with opioidActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
chronic breast pain at 1 year after mastectomy
chronic pain will be assessed by Breast Cancer Pain Questionnaire (BCPQ). Zero score means absence of persisting breast-related pain. The minimum and maximum values of pain scale are 0 and 11, respectively. High score means worse outcome. Moderating role of preoperative psychosocial factors on the impact of OFA on chronic postoperative pain will be evaluated.
Time frame
1 year after mastectomySecondary outcomes
1
psychological symptoms
Presence of anxiety and depression symptoms will be assessed by HADS (Hospital Anxiety and Depression Scale) questionnaire. The range of each symptoms scale is between 0 and 21. A scale of 0-7 is defined as normal, a scale of 8-10 is defined as borderline, and a scale of 11-21 is defined as abnormal. High score means worse outcome.
Time frame
1 year after mastectomy2
Pain Sensitivity
The type of pain will be assessed by painDetect Questionnaire (PDQ). The PDQ comprises 12 items. The first three assess current pain, strongest pain during the past 4 weeks, and average pain during the past 4 weeks on a 0-10 point numerical rating scale from "none" to "worst imaginable".
Time frame
1 year after mastectomySponsors and contacts
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Source ClinicalTrials.gov