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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Post Operative Pain, Cesarean Section Pain

Intervention / Treatment
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* Drug: NSAID , NALUFIN , local anesthetic andTAP Block


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NSAID<br>The Control group will be given nothing and only non-steroidal anti-inflammatory drugs on need | Drug: NSAID , NALUFIN , local anesthetic andTAP Block<br>* 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<br>|
| Active Comparator: Nalufin<br>group will be given IV nalufin | Drug: NSAID , NALUFIN , local anesthetic andTAP Block<br>* 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<br>|
| Active Comparator: local anesthetic group<br>the local anesthetic group will be given a S.C injection of local anesthetic in the wound | Drug: NSAID , NALUFIN , local anesthetic andTAP Block<br>* 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<br>|
| Active Comparator: TAP block<br>Total abdominal plain block group will be given a TAP block | Drug: NSAID , NALUFIN , local anesthetic andTAP Block<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post Operative Pain | 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 | 2 hours after the Cesarean Section till the pain relief |