Status:
UNKNOWN
The Safety and Efficacy of Surgical Rectus Sheath Block for Postoperative Analgesia After Elective Cesarean Delivery
Lead Sponsor:
Ahmed M Maged, MD
Conditions:
Post Operative Pain
Eligibility:
FEMALE
20-35 years
Phase:
NA
Brief Summary
All participants will receive spinal anaesthesia and will be randomly divided into 2 equal groups. In Group 1, 20 ml of local anesthetic solution will be administered bilaterally to the rectus sheath ...
Detailed Description
All participants will receive spinal anaesthesia and will be randomly divided into 2 equal groups. In Group 1, 20 ml of local anesthetic solution will be administered bilaterally to the rectus sheath ...
Eligibility Criteria
Inclusion
- Women with singleton pregnancies.
- Gestational age 37 to 41 weeks.
- Surgical history: no history of previous surgeries or history of previous 1 cesarean section,
- Age: 20 -35 years old,
- American Society of Anesthesiologists physical status classifications II (healthy pregnancy or with mild systemic disease) \[Amr E. Abouleish et. al. 2015\],
- Scheduled for elective cesarean section
- BMI: 18.5 - 35 kg/m2.
Exclusion
- if they had American Society of Anaesthesiologists (ASA) status III and above (with severe systemic disease),
- Patients with BMI \< 18.5 or \> 35 kg/m2 were excluded as they require a different dosage of drug for spinal anesthesia,
- History of previous 2 Caesarian or more,
- Known allergy to the drug used (bupivacaine),
- Contraindication to NSAID: patients with suspected or manifest bleeding disturbances, allergy to NSAID, atopia, bronchial asthma, diabetes mellitus, those who previously had shown marked side effects after NSAID, the presence of liver or kidney disease, abuse of drugs or alcohol, excessive smokers and patients with pregnancy induced hypertension or pre-eclampsia
- Bleeding disorders, e.g.: thrombocytopenia,
- Neurological disorders associated with sensory alterations, e.g., Transverse myelitis can cause back pain, abnormal sensations in the trunk and genital region and legs such as sensory loss or paresthesias (abnormal sensations such as burning, tickling, pricking, numbness, coldness, or tingling).
- Rheumatological diseases e.g., primary Sjögren's syndrome (pSS), systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA), accompanied by chronic widespread pain due to arthralgia, myalgia or serositis.
- Requiring general anesthesia,
- if vertical abdominal incision was required,
- Local infection at the site of injection or
- The inability to provide a pain score, e.g., visual impairement.
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2024
Estimated Enrollment :
182 Patients enrolled
Trial Details
Trial ID
NCT06020196
Start Date
September 1 2023
End Date
April 1 2024
Last Update
August 31 2023
Active Locations (1)
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1
The Obstetrics and Gynecology department of Kasr Alainy University Hospital
Cairo, El Manial, Egypt, 11562