Pain, Postoperative Clinical Trial
— qlcsectionOfficial title:
QL Block for Post-cesarean Delivery Pain
Comparison of standard post-operative cesarean surgery pain management with regional post-op pain control.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 31, 2022 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: - Elective cesarean planned under spinal anesthesia - Singleton pregnancy - American Society of Anesthesiologists (ASA) classification score of 2 (or less) - Gestational age of at least 37 weeks - Intention to breastfeed infant Exclusion Criteria: - Contraindications to neuraxial blockade (such as clinically relevant coagulopathy, recent anticoagulant use, patient refusal, or localized skin infection overlying the site of needle entry) - Anatomical abnormalities contraindicating spinal or QLB placement - Received/Conversion to general anesthesia - Received supplemental parenteral anesthesia (sedation) for any reason (e.g. unanticipated prolonged surgical procedure) - History of chronic pain - History of chronic opioid use/abuse - History of Subutex, methadone, other maintenance therapy |
Country | Name | City | State |
---|---|---|---|
United States | Magee Women's Hospital of UPMC | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Nicholas Schott |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | VAS pain score with movement | Post-operative pain accompanied with patient movement will be measured using a 10 point pain scale (VAS) | 24 hours after surgical procedure (cesarean delivery) | |
Secondary | Breast feeding success/quality | Limited breastfeeding resulting from pain or opioid side effects | 12, 24 and 36 hours post-operatively | |
Secondary | VAS pain score at rest | VAS pain score reported by the patient at rest post-operatively using a 10 point pain scale (VAS) | At baseline (PACU entry) and 1, 4, 24 and 48 hours after intervention | |
Secondary | First request for pain medication | Time to first request for as desired (PRN) oral or parenteral opioid medication will be assessed | From post-operative until the patient is either withdrawn from the study or requests analgesic medication up until 72 hours | |
Secondary | Sedation | Presence or absence will be noted | From post-operative until the patient is either withdrawn from study or experiences this event up until 72 hours | |
Secondary | Pruritis | Presence or absence will be noted | From post-operative until the patient is either withdrawn from study or experiences this event up until 72 hours | |
Secondary | Nausea | Presence or absence will be noted | From post-operative until the patient is either withdrawn from study or experiences this event up until 72 hours | |
Secondary | Emesis | Presence or absence will be noted | From post-operative until the patient is either withdrawn from study or experiences this event up until 72 hours | |
Secondary | Heart Rate | Will be measured in beats/minute (BPM) per standard of care and documented by study staff | From post-operative every 24 hours until the patient is either withdrawn from or completes the study, on average 72 hours | |
Secondary | Anesthetic toxicity | symptoms indicating this event such as perioral numbness, ringing in the ears or metallic taste in the mouth will be noted | 15 min, 30 min, 45 min, 1 hour, and 4 hours post-operatively | |
Secondary | Blood pressure | Will be measured in mmHG per standard of care and documented by study staff | From post-operative every 24 hours until the patient is either withdrawn from or completes the study, on average 72 hours | |
Secondary | Respiratory Rate | Will be measured in rate/min per standard of care and documented by study staff | From post-operative every 24 hours until the patient is either withdrawn from or completes the study, on average 72 hours | |
Secondary | Oxygen Saturation | Will be measured in % per standard of care and documented by study staff | From post-operative every 24 hours until the patient is either withdrawn from or completes the study, on average 72 hours | |
Secondary | 36-Item Short Form Survey (SF-36) | Quality of life measures will be assessed using the SF-36 | 48-hours post-operatively | |
Secondary | Brief Pain Inventory (BPI) - Short Form | Severity of pain and its impact on functioning using BPI Short Form | 6-weeks post operatively | |
Secondary | Edinburgh Postnatal Depression Scale (EPDS) | Possible symptoms of depression in the postnatal period will be assessed via EPDS | 6-weeks post operatively | |
Secondary | Dynamic Pain Visual Analogue scale | Pain score reported by the patient at rest using the VAS scale | 6-weeks postoperatively | |
Secondary | Opioid use | Total opioid consumption post-operative | From post-operative until 36 hours and at 6-weeks postoperatively or until the patient is discharged or withdrawn from study |
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