Application of Transversus Abdominus Plain Block, Local Subcutaneous Injection and IV Nalbuphine
NCT05276206
Phase
Phase 1
Recruitment status
Completed
Participants
Lead sponsor
Egymedicalpedia
Start date
2022-03-07
Number of sites
- Summary
- 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
- Short title
- Application of Transversus Abdominus Plain Block, Local Subcutaneous Injection and IV Nalbuphine
- Official title
- Comparative Study Between Transversus Abdominus Plain Block, Local Subcutaneous Injection in the Wound, and Intravenous Nalbuphine in Decreasing Postoperative Pain in Cesarean Section
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2022-04-01
- First posted
- 2022-03-11
- Registry last updated
- 2023-07-10
- Primary completion date
- 2022-03-20
- Start date
- 2022-03-07
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Egymedicalpedia
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05276206
- ClinicalTrials.gov ID
- NCT05276206
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Factorial
- Purpose
- Treatment
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
Sources for study design
Post Operative Pain
Timeframe: 2 hours after the Cesarean Section till the pain relief
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
Sources for outcomes
- Sex
- Female
- Age groups
- Adults
- Minimum age
- 20 Years
- Maximum age
- 35 Years
- Healthy volunteers
- Yes
- Pregnant women aged 20-35 years
- Gestational age between 37-40 weeks
- Pregnant women undergoing elective cesarean section
- Medically free
- Singleton pregnancy
- Emergency cesarean section
- Diabetic
- Hypertensive
- Severe anemia
- Multiple pregnancy
- Complication during section
Sources for eligibility
- Al-Azhar UniversityCairo, Egypt
Sources for sites