Regional Analgesia After Cesarean Section
NCT03244540 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 105
Last updated 2020-02-18
Summary
All patients will be anaesthetized with spinal technique. Each patient will be treated with intravenous morphine - patient controlled analgesia (PCA). 2 of 3 groups of patients will receive ultrasound-guided transversus abdominis plane or quadratus lumborum block to treat postoperative pain. Postoperative pain will measured with visual-analogue scale (VAS). Total morphine consumption and time to the first demand will be noted. 1, 2, 6 months after surgery each patient will be called to assess neuropathic pain with Neuropathic Pain Symptom Inventory (NPSI).
Conditions
- Cesarean Section
- Pain, Postoperative
- Pain, Neuropathic
Interventions
- PROCEDURE
-
TAP (transversus abdominis plane block)
ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain
- PROCEDURE
-
QLB (quadratus lumborum block)
ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain
- DEVICE
-
Stimuplex Ultra 360 needle
ultrasound-guided needle will be used for QLB and TAP and regional blocks
- DRUG
-
Ropivacaine
0.375 % ropivacaine will be administered for both QLB and TAP (0.2 mL per kg on both sides)
- DRUG
-
Intravenous paracetamol will be used (1.0 gram), up to 4 grams per day
- PROCEDURE
-
subarachnoid anesthesia
subarachnoid anesthesia for each patients participating in the study with pencil point needle
- PROCEDURE
-
PCA (patient controlled analgesia)
All patients will receive PCA pump with morphine (1 mg/mL, 5 minute interval, no loading dose) after transfer to PACU (post-anesthesia care unit)
- DRUG
-
Metamizol
Intravenous metamizol will be used (1.0 gram), up to 4 grams per day
- DRUG
-
Ketoprofen
Intravenous ketoprofen will be used (0.1 gram), up to 200 milligrams per day
- DRUG
-
Bupivacaine
Subarachnoid anesthesia with spinal bupivacaine (MARCAINE SPINAL 0.5% HEAVY)
Sponsors & Collaborators
-
Medical University of Lublin
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-09-04
- Primary Completion
- 2018-10-29
- Completion
- 2019-08-30
Countries
- Poland
Study Locations
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