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IRCT20260208068799N1 IRCT 2026-06-08 Shahid Beheshti University of Medical Sciences Bupivacaine, fentanyl, and dexmedetomidine in cesarean section. A comparison study of bupivacaine 0.25% with fentanyl versus bupivacaine 0.25% with Dexmedetomidine in TAP block for postoperative analgesia following a cesarean section. 2026-07-02 anticipated 70 Pending https://irct.ir/trial/90373 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After eligibility assessment and obtaining written informed consent, eligible participants will be randomly allocated to one of the two study groups in a 1:1 ratio. The random allocation sequence will be generated by an independent person who is not involved in patient recruitment, intervention administration, outcome assessment, or data analysis, using a computer-generated random number sequence. Block randomization with variable block sizes will be used to maintain balance between the two study groups. Allocation concealment will be ensured using sequentially numbered, opaque, sealed, light-proof envelopes. Each envelope will be opened only after the participant has been definitively enrolled in the study and immediately before preparation of the study medication. Study medications will be prepared by an independent person and provided in identical syringes with coded labels, similar in appearance and volume. Participants, the anesthesiologist performing the TAP block, postoperative care staff, outcome assessors, and the statistician will remain blinded to group allocation, Blinding description: This study is designed as a double-blind randomized clinical trial. Participants, the anesthesiologist performing the TAP block, postoperative care staff, outcome assessors, and the statistician will remain unaware of participants’ group allocation. The allocation sequence and group codes will be generated and kept by an independent person who is not involved in patient care, intervention administration, data collection, outcome assessment, or statistical analysis. Study medications will be prepared by the same independent person, or by a trained pharmacist/nurse who has no role in patient assessment or data analysis. For each participant, the study medication will be prepared according to the randomization code in identical syringes with similar volume, appearance, and coded labeling. The syringes will be labeled only with the study code and participant number, and the name of the medication will not be written on the syringe. In both groups, the final injected volume for the TAP block will be identical, and the study solutions will not be distinguishable by appearance. Bilateral TAP block will be performed in both groups using the same technique, at the same anatomical site, with the same injection volume, and under ultrasound guidance. Therefore, the participant, the anesthesiologist performing the block, and the outcome assessor will not be able to identify the treatment group. Assessment of pain intensity, duration of analgesia, time to first request for rescue analgesia, rescue analgesic consumption, maternal satisfaction, and adverse events will be performed by an assessor blinded to group allocation. Data will be entered into the statistical software using coded group labels, such as Group A and Group B, and the statistician will remain blinded to the actual intervention assigned to each group until completion of the primary analysis. Allocation codes will remain confidential until completion of data collection and primary statistical analysis. In case of a serious adverse event or emergency situation in which knowledge of the administered study medication is necessary for patient management, unblinding for that individual participant will be permitted by the principal investigator or the study safety supervisor. The reason, time, and person responsible for unblinding will be documented and reported. N/A cesarean section. Intervention 1: Intervention group: Intervention group: Participants in this group will receive ultrasound-guided bilateral transversus abdominis plane block at the end of elective cesarean section under general anesthesia. The block will be performed using 40 mL of 0.25% bupivacaine, 20 mL on each side, plus dexmedetomidine 1 µg/kg as an adjuvant. The intervention will be administered as a single-dose bilateral block. Intervention 2: Control group: Participants in this group will receive ultrasound-guided bilateral transversus abdominis plane block at the end of elective cesarean section under general anesthesia. The block will be performed using 40 mL of 0.25% bupivacaine, 20 mL on each side, plus fentanyl 1 µg/kg as an active comparator. The intervention will be administered as a single-dose bilateral block. Yes - There is a plan to make this available What will be shared: Deidentified Individual Participant Data for the TAP Block Trial in Elective Cesarean Section When: After data collection completion To whom: Other researchers Conditions: belonging to academic institution Where to obtain: researcher's personal email minavishteh62@sbmu.ac.ir How to obtain: requesting by email Comments:
public Mina Vishteh
Pasdaran, Paydar Far St., corner of Bostan 9th.
Tehran Iran (Islamic Republic of) 1666663111 +98 21 23601 minavishteh62@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Mina Vishteh
Pasdaran, Paydar Far St., corner of Bostan 9th.
Tehran Iran (Islamic Republic of) 1666663111 +98 21 23601 minavishteh62@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Pregnant women aged 18 to 45 years. Scheduled for elective cesarean section under general anesthesia. American Society of Anesthesiologists physical status class I or II. Singleton pregnancy. No major obstetric or surgical complication before the operation. Cesarean section performed without any concomitant surgery or additional surgical intervention. Ability to understand and report pain intensity using the visual analogue scale, VAS. Provision of written informed consent to participate in the study. 18 years 45 years Female Withdrawal of consent or unwillingness to continue participation at any stage of the study. American Society of Anesthesiologists physical status class III or higher. Emergency cesarean section. Major intraoperative complications, including severe bleeding, visceral injury, hemodynamic instability, or the need for unusual therapeutic intervention. Requirement for concomitant surgery or any additional surgical intervention during cesarean section. Known allergy or contraindication to bupivacaine, dexmedetomidine, fentanyl, or any other medication used in the study. Coagulation disorders or current use of anticoagulant medications. Infection at the TAP block injection site. History of chronic opioid use, sedative use, or long-term analgesic medication use. Presence of chronic abdominal, pelvic, or low back pain that may interfere with postoperative pain assessment. History of psychiatric or cognitive disorders affecting the patient’s ability to report pain. Inability to understand or use the visual analogue scale, VAS. Failed or incomplete TAP block based on clinical assessment by the anesthesiologist. Serious complications related to general anesthesia or regional block requiring a major change in the patient’s treatment plan. Incomplete data regarding the primary outcome of the study. O82.0 Delivery by elective caesarean section Treatment - Drugs Treatment - Drugs Intervention group: Intervention group: Participants in this group will receive ultrasound-guided bilateral transversus abdominis plane block at the end of elective cesarean section under general anesthesia. The block will be performed using 40 mL of 0.25% bupivacaine, 20 mL on each side, plus dexmedetomidine 1 µg/kg as an adjuvant. The intervention will be administered as a single-dose bilateral block. Control group: Participants in this group will receive ultrasound-guided bilateral transversus abdominis plane block at the end of elective cesarean section under general anesthesia. The block will be performed using 40 mL of 0.25% bupivacaine, 20 mL on each side, plus fentanyl 1 µg/kg as an active comparator. The intervention will be administered as a single-dose bilateral block. Postoperative pain intensity will be assessed using the Visual Analogue Scale, VAS, at 6 hours after cesarean section. The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. The primary outcome will be the comparison of the mean VAS score at 6 hours postoperatively between the two intervention groups. Timepoint: Postoperative pain intensity will be assessed at 6 hours after completion of cesarean section and performance of the ultrasound-guided bilateral TAP block. Method of measurement: Postoperative pain intensity will be measured using the Visual Analogue Scale (VAS). The patient will be asked to rate her pain on a 0–10 scale, where 0 indicates no pain and 10 indicates the worst imaginable pain. The VAS score will be recorded by a trained outcome assessor who is blinded to the study group allocation. Shahid Beheshti University of Medical Sciences Approved 2026-02-05 School of Medicine - Shahid Beheshti University of Medical Sciences (Research Ethics Committee) Shahid Chamran Highway- Evin- next to Taleghani Hospital- Medical School- third floor Tehran Tehran Iran (Islamic Republic of)