Faculty of Medicine Alexandria University
Alexandria, Alexandria Governorate, Egypt
NCT Number: NCT06871033
The current study investigates the efficacy and safety of ketamine and neostigmine as adjuvants in transversus abdominis plane blocks for Cesarean sections. The study participants arerandomized into two groups, each receiving either ketamine or neostigmine alongside plain bupivacaine. Various parameters, including pain intensity, intraoperative and postoperative hemodynamics, rescue analgesia requirements, patient satisfaction, and postoperative complications, are evaluated and compared between the two groups.
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Interventional
Phase 3
Alexandria, Alexandria Governorate, Egypt
A prospective, experimental double-blind control study will be conducted in Alexandria Main University Hospital after approval of the medical ethics committee of the Alexandria Faculty of Medicine and a written formal consent will be signed out from patients or their relatives. Patients will be double-blinded randomized into two equal groups (40 patients each) after receiving spinal anesthesia with 12.5 mg of 0.5% hyperbaric bupivacaine:
Preoperative assessment and preparation:
Patient preparation:
The patients receive:
The TAP block will be performed using Sonosite M-turbo ultrasound with high-frequency (10-15 MHz) linear transducer. The skin will be disinfected with antiseptic solution. A linear transducer will be placed in the axial plane on the midaxillary line between the subcostal margin and the iliac crest. The three layers of abdominal wall muscles will be visualized: external and internal oblique as well as the transversus abdominis muscles. The target is the fascial plane between the internal oblique and the transversus abdominis muscles. The needle will be inserted in the anterior axillary line, and the needle tip will be advanced until it reaches the fascial plane then 20 ml of 0.25% plain bupivacaine and 0.5 mg/kg ketamine will be injected in the first group and 50 microgram neostigmine in the second group under repeated aspiration for every 5 milliliters separating the plane between the internal oblique and transversus abdominis muscles with increased radiotranslucency approximately in the midaxillary line. The identical technique will be repeated on the opposite side.
Over the next 24 hours, all patients received 1 g of paracetamol IV every 8 hour as a part of multimodal analgesia. Measurements
The following parameters will be measured in every patient in the study:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
40 patients will receive postoperative TAP block with 20ml 0.25% plain bupivacaine (10ml 0.5% bupivacaine added to 10ml normal saline) and 500 microgram neostigmine for each side.
40 patients will receive postoperative TAP block with 20 ml 0.25% plain bupivacaine (10ml 0.5% bupivacaine added to 10ml normal saline) and 0.5 mg/kg ketamine for each side.
Time frame: Intraoperatively and at 2 hr., 4 hr., 6 hr., 12 hr., 18hr., and 24 hr. postoperatively
Change From Baseline in Pain Scores on the Visual Analog Scale
Time frame: 24 hours postoperative
Patient satisfaction with the pain control will be assessed on a four-point scale as: Excellent, Good, Fair and Poor.
Alexandria University
Other
Comparison Between Ketamine and Neostigmine As Adjuvants to Bupivacaine in Ultrasound-Guided Transversus Abdominis Plane Block in Caesarean Section
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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