Assessment of efficacy of local anesthetic injection to abdominal Wall in Patients Undergoing Cesarean Section with Spinal Anesthesia

Assessment of Postoperative Analgesia with Transversus Abdominus Plane Block in Patients Undergoing Cesarean Section with Spinal Anesthesia

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12616000719437

Enrollment

Registered

2016-05-31

Start date

2016-06-06

Completion date

2016-09-29

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

After obtainment of ethics committee approval and written informed consent from patients, a total of 60 women between 18 and 45 years of age with an ASA risk status of I-II and undergoing elective cesarean section under spinal anesthesia will include in this study. Patients will divide into two groups as follows: those who receive postoperative TAPB under ultrasound guidance (Group TAPB, 20 ml of 0.25% bupivacaine administere bilaterally), and those who will not receive postoperative TAPB (Group C). Also, all patients will provide patient-controlled analgesia with tramadol (loading dose of 20 mg, with a lock-out time of 10 minutes and basal infusion rate of 20 mg/hour). In order to assess the level of postoperative analgesia, VAS scores will record with 5-minute intervals after entry into the recovery room and at postoperative 1, 2, 4, 6, 12 and 24 hours. Also record will the tramadol doses at recovery and at postoperative 24 hours. Patient satisfaction will asses postoperatively at 24 hours.

Interventions

Ultrasound guided transversus abdominis plane blocks will be performed in pregnant women undergoing elective cesarean section with spinal anesthesia. Total of 60 women between 18 and 45 years of age with an ASA risk status of I-II and undergoing elective cesarean section under spinal anesthesia will include in this study. Patients will divide into two groups as follows: those who receive postoperative TAPB under ultrasound guidance (Group TAPB, 20 ml of 0.25% bupivacaine administered on each side, bilaterally, total dose: 40 ml) by consultant anesthetist, and those who do not receive postoperative TAPB (Group C). Also, all patients will provide patient-controlled analgesia with tramadol at first 24 hours(loading dose of 20 mg, with a lock-out time of 10 minutes and basal infusion rate of 20 mg/hour)

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

elective cesarean section under spinal anesthesia 18 and 45 years of age ASA risk status I-II

Exclusion criteria

Cardiovascular system acting drugs, congestive heart failure, diabetes mellitus, haematological disorders, chronic pain syndrome or recent use of analgesics, obesity (BMI> 30 kg / m2) sepsis, bacteremia, local skin infection, hypovolemia, coagulopathy, therapeutic anticoagulation, increased intracranial pressure, the refusal of the patient's treatment repeated cesarean ones, placenta previa, placenta accreta, increate, placental abnormalities, such as perkeat to, eclampsia and preeclampsia, allergy to local anesthetics

Outcome results