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Application of Transversus Abdominus Plain Block, Local Subcutaneous Injection and IV Nalbuphine

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05276206
Enrollment
400
Registered
2022-03-11
Start date
2022-03-07
Completion date
2022-04-01
Last updated
2023-07-10

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

Conditions

Cesarean Section Pain, Post Operative Pain

Brief 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

Detailed description

Local wound infiltration is an attractive strategy since it is efficacious and side effects are minimal. Nowadays, there is a trend toward preferring ropivacaine over other local anesthetic agents due to the longer duration of action and better safety profile. Local anesthetic infiltration, however, has a limitation in that pain relief is offered till the effects of local anesthetic action lasts. Efforts are being made to prolong the duration of action of local anesthetic skin infiltration, and dexmedetomidine is one such agent which can potentiate and prolong the duration of local anesthetic wound infiltration for pain relief. A transversus abdominis plane (TAP) block provides analgesia of the anterior and lateral abdominal wall below the umbilicus by blocking the T6-L1 segmental nerves as they lie within the fascial plane between the transversus abdominis and internal oblique muscles: bilateral block for midline abdominal incision. It was first described in 2001 by Rafi as a traditional blind landmark technique using the lumbar triangle of Petit. Local anesthetic is then injected between the internal oblique and transverse abdominis muscles just deep the fascial plane, the plane through which the sensory nerves pass

Interventions

DRUGNSAID , 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

Sponsors

Egymedicalpedia
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 35 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Post Operative Pain2 hours after the Cesarean Section till the pain reliefThe 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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026