Application of Transversus Abdominus Plain Block, Local Subcutaneous Injection and IV Nalbuphine
Primary Purpose
Post Operative Pain, Cesarean Section Pain
Status
Completed
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
NSAID , NALUFIN , local anesthetic andTAP Block
Sponsored by
About this trial
This is an interventional treatment trial for Post Operative Pain
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
Sites / Locations
- Al-Azhar University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
NSAID
Nalufin
local anesthetic group
TAP block
Arm Description
The Control group will be given nothing and only non-steroidal anti-inflammatory drugs on need
group will be given IV nalufin
the local anesthetic group will be given a S.C injection of local anesthetic in the wound
Total abdominal plain block group will be given a TAP block
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05276206
Brief 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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
March 7, 2022 (Actual)
Primary Completion Date
March 20, 2022 (Actual)
Study Completion Date
April 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Egymedicalpedia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain, Cesarean Section Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NSAID
Arm Type
Active Comparator
Arm Description
The Control group will be given nothing and only non-steroidal anti-inflammatory drugs on need
Arm Title
Nalufin
Arm Type
Active Comparator
Arm Description
group will be given IV nalufin
Arm Title
local anesthetic group
Arm Type
Active Comparator
Arm Description
the local anesthetic group will be given a S.C injection of local anesthetic in the wound
Arm Title
TAP block
Arm Type
Active Comparator
Arm Description
Total abdominal plain block group will be given a TAP block
Intervention Type
Drug
Intervention Name(s)
NSAID , NALUFIN , local anesthetic andTAP Block
Intervention Description
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
Primary Outcome Measure Information:
Title
Post Operative Pain
Description
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
Time Frame
2 hours after the Cesarean Section till the pain relief
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ElSayed ElDesouky, Professor
Organizational Affiliation
Al-Azhar University, Faculty of medicine for boys
Official's Role
Principal Investigator
Facility Information:
Facility Name
Al-Azhar University
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Application of Transversus Abdominus Plain Block, Local Subcutaneous Injection and IV Nalbuphine
We'll reach out to this number within 24 hrs