Clinical trial

Comparative Study Between Transversus Abdominus Plain Block, Local Subcutaneous Injection in the Wound, and Intravenous Nalbuphine in Decreasing Postoperative Pain in Cesarean Section

Name

Mahmoud Raslan

Description

Approximately 1 in 5 women who undergo CS will experience severe acute postoperative pain. The severity of pain in the acute postoperative period is a significant predictor for the development of chronic pain, which occurs in 9.2%-18% of women who undergo CS. Furthermore, severe acute post-cesarean pain triples a woman's risk of developing postpartum depression and negatively affects breastfeeding and infant care. For these reasons, it is imperative to provide adequate postoperative analgesia in this patient population

Trial arms

Trial start

2022-03-07

Estimated PCD

2022-03-20

Trial end

2022-04-01

Status

Completed

Phase

Early phase I

Treatment

NSAID , NALUFIN , local anesthetic andTAP Block

The pain level of the cases is evaluated by means of the digital pain (numeric rating) scale from 0 to 10 in which 0 means "no pain" and 10 means "the worst pain" as well as the duration of pain relief and the need for another dose of the same analgesic or other. The pain level is evaluated again if it is present. In all groups non steroidal anti-inflammatory drugs will be given as a rescue analgesic and the total dose will be calculated and compared

Arms:

NSAID, Nalufin, TAP block, local anesthetic group

Size

400

Primary endpoint

Post Operative Pain

2 hours after the Cesarean Section till the pain relief

Eligibility criteria

Inclusion Criteria: * Pregnant women aged 20-35 years * Gestational age between 37-40 weeks * Pregnant women undergoing elective cesarean section * Medically free * Singleton pregnancy Exclusion Criteria: * Emergency cesarean section * Diabetic * Hypertensive * Severe anemia * Multiple pregnancy * Complication during section

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'FACTORIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 400, 'type': 'ACTUAL'}}

Updated at

2023-07-10

1 organization

Organization

Egymedicalpedia