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IRCT20240221061070N11 IRCT 2026-01-07 Esfahan University of Medical Sciences Preventive effect of dexamethasone and paracetamol on postoperative pain following cesarean section Comparative study of the preventive effect of different doses of dexamethasone and paracetamol on postoperative pain in patients undergoing cesarean section 2025-11-22 anticipated 200 Complete https://irct.ir/trial/87141 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: After confirmation of the inclusion and exclusion criteria and obtaining written informed consent, eligible participants will be randomly allocated to one of the five study groups. Randomization will be performed using the Random Sequence Generator available at www.random.org. To ensure a balanced distribution of participants among the study groups, block randomization with fixed blocks of 15 will be applied, such that within each block participants are equally assigned to five groups (A, B, C, D, and E), including intravenous dexamethasone 2 mg, intravenous dexamethasone 4 mg, intravenous dexamethasone 6 mg, intravenous paracetamol 1 g, and normal saline (control group). Participant allocation will be carried out according to the order of enrollment and based on a pre-generated randomization list. Allocation concealment will be ensured by preparation of all study interventions in identical, coded syringes by an independent anesthesiologist who is not involved in patient assessment, and the prepared medications will be delivered to the study investigator. This study will be conducted as a triple-blind trial, in which the participants, the investigator, and the statistical analyst will remain unaware of the allocated treatment until completion of data analysis, Blinding description: This study is designed as a triple‑blind randomized controlled trial to minimize bias during the intervention, outcome assessment, and data analysis phases. Participants will be blinded to both the allocated group and the type of medication administered. The medical staff directly involved in patient care during surgery and the postoperative period, including anesthesiologists and ward nurses, will also be unaware of group allocation. The outcome assessor, who records data related to pain assessment and patient satisfaction, will remain blinded to the type of intervention. Finally, the statistician responsible for the final data analysis will receive the dataset with coded group assignments and will be unaware of the treatment identities. To ensure blinding, all study medications will be prepared in identical, visually indistinguishable syringes and labeled with encrypted codes. The only unblinded individual will be an anesthesia assistant responsible for preparing and coding the syringes according to the randomization sequence; however, this individual will not participate in drug administration, patient assessment, or data analysis. 3 Post‑Cesarean Pain (Postoperative Pain after Cesarean Section). Intervention 1: Intervention Group 1 (Intravenous dexamethasone 2 mg):In this group, aiming to evaluate the preventive effect of low‑dose dexamethasone on postoperative pain intensity, after obtaining written informed consent, patients will receive 10 mg of intravenous metoclopramide as premedication upon arrival in the operating room. Two 18‑gauge intravenous catheters will then be inserted into the upper extremities, followed by preload hydration with warmed Ringer’s lactate solution (using a fixed fluid warmer for one hour, without the use of an in‑line warming device) at a dose of 10 mL/kg over 30 minutes.Spinal anesthesia will be performed at the L4–L5 intervertebral space in the sitting position, using a 26‑gauge Quincke spinal needle via the paramedian approach. All patients will receive 2.5 mL of 0.5% hyperbaric bupivacaine administered intrathecally.Immediately after completion of spinal anesthesia, the intervention drug consisting of 2 mg intravenous dexamethasone (manufactured by Iran Darou Pharmaceutical Company), diluted in a syringe containing normal saline (0.9%), will be administered slowly over approximately one minute via the intravenous route.To maintain blinding, all study medications will be prepared according to the randomization list by an anesthesiologist not involved in the execution of the study and will be provided to the study administrator in identical, coded syringes for administration. Intervention 2: Intervention Group 2 (Intravenous dexamethasone 4 mg):In this group, aiming to evaluate the preventive effect of a moderate dose of dexamethasone on postoperative pain intensity, after obtaining informed consent, patients receive 10 mg of intravenous metoclopramide as premedication upon arrival in the operating room. Subsequently, two 18G intravenous catheters are inserted in the upper limbs, and preload with warmed Ringer’s lactate solution (10 mL/kg over 30 minutes) is performed.Spinal anesthesia is performed at the L4–L5 intervertebral space in the sitting position using a 26G Quincke needle via the paramedian approach, and 2.5 mL of 0.5% hyperbaric bupivacaine is injected.Immediately after spinal anesthesia, 4 mg of injectable dexamethasone sodium phosphate (a clear, colorless solution with a concentration of 4 mg/mL) is administered as a single intravenous dose, injected slowly over approximately one minute. The dexamethasone used is a commercially available product manufactured by Iran Darou Pharmaceutical Company.The medication is prepared by an anesthesiologist not involved in the research team, using identical syringes diluted with normal saline and coded to ensure complete blinding. Throughout the study, the drug is administered only once, with no repeated dosing. Intervention 3: Intervention Group 3 (Intravenous dexamethasone 6 mg):In this group, aiming to evaluate the analgesic and anti‑inflammatory effects of a high dose of dexamethasone, after obtaining informed consent, patients receive 10 mg of intravenous metoclopramide as premedication upon arrival in the operating room. Subsequently, two 18G intravenous catheters are inserted in the upper limbs, and preload with warmed Ringer’s lactate solution at a dose of 10 mL/kg over 30 minutes is performed.Spinal anesthesia is carried out at the L4–L5 intervertebral space in the sitting position using a 26G Quincke needle via the paramedian approach, followed by injection of 2.5 mL of 0.5% hyperbaric bupivacaine.Immediately after spinal anesthesia, 6 mg of injectable dexamethasone sodium phosphate (a clear, colorless solution with a concentration of 4 mg/mL) is administered as a single intravenous dose, injected slowly over approximately one minute. The dexamethasone used is a commercially available preparation manufactured by Iran Darou Pharmaceutical Company.All study medications are prepared by an anesthesiologist not involved in the research team, using identical syringes diluted with normal saline and coded, in order to ensure complete triple blinding. The study drug is administered only once, with no repeated dosing during the trial. Intervention 4: Intervention Group 4 (Intravenous paracetamol 1 g):In this group, aiming to evaluate the preventive effect of paracetamol on postoperative pain intensity following cesarean section, after obtaining informed consent, patients receive 10 mg of intravenous metoclopramide as premedication upon arrival in the operating room. Subsequently, two 18G intravenous catheters are inserted in the upper limbs, and preload with warmed Ringer’s lactate solution at a dose of 10 mL/kg over 30 minutes is performed.Spinal anesthesia is performed similarly to the other groups at the L4–L5 intervertebral space in the sitting position using a 26G Quincke needle via the paramedian approach, followed by injection of 2.5 mL of 0.5% hyperbaric bupivacaine.Then, 15 minutes before the start of cesarean surgery, 1 g of intravenous paracetamol (acetaminophen), provided as a ready-to-use injectable solution containing 10 mg/mL paracetamol, diluted in 100 mL of normal saline, is administered over 10–15 minutes using a microset infusion system. The paracetamol used is a commercially available product manufactured by Iran Darou Pharmaceutical Company.The study medication is prepared by an anesthesiologist not involved in the research team, using identical infusion sets and containers, diluted with normal saline and coded, to ensure complete blinding. The drug is administered only once during the study, with no repeated dosing. Intervention 5: In the control group, after obtaining written informed consent, patients will receive 10 mg of intravenous metoclopramide as premedication upon arrival in the operating room. Two 18‑gauge intravenous catheters will be inserted into the upper extremities, and preload hydration with warmed Ringer’s lactate solution will be administered at a dose of 10 mL/kg over 30 minutes.Spinal anesthesia, identical to that performed in the other groups, will be administered at the L4–L5 intervertebral space using a 26‑gauge Quincke spinal needle via the paramedian approach, and 2.5 mL of 0.5% hyperbaric bupivacaine will be injected intrathecally.Following spinal anesthesia, patients in the control group will receive 100 mL of intravenous normal saline as a placebo, administered slowly over approximately one minute. This solution will be prepared in syringes identical in appearance to those used for the other study medications and coded in the same manner to maintain triple blinding. No - There is not a plan to make this available Justification or reason for not sharing IPD is The data is private
public Milad Masaeli
Apposite of Asman Hotel, The beginning of Shahid Motahari St, Felezzi Bridge, Isfahan
Isfahan Iran (Islamic Republic of) 81848-53541 +98 31 3236 7001 drmilmas@gmail.com Esfahan University of Medical Sciences scientific Milad Masaeli
Apposite of Asman Hotel, The beginning of Shahid Motahari St, Felezzi Bridge, Isfahan
Isfahan Iran (Islamic Republic of) 81848-53541 +98 31 3236 7001 drmilmas@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Women with American Society of Anesthesiologists (ASA) physical status class I Age range between 18 and 45 years Candidates for elective cesarean section under spinal anesthesia 18 years 45 years Female Known cardiac, pulmonary, hepatic, or renal disease Psychiatric disorders, diabetes mellitus, or thyroid dysfunction Body temperature at operating room admission < 36.5 °C or > 37.5 °C History of alcohol or substance abuse Use of vasodilator medications Requirement of intraoperative blood transfusion G89.18 Other acute postprocedural pain Prevention Prevention Prevention Prevention Placebo Intervention Group 1 (Intravenous dexamethasone 2 mg):In this group, aiming to evaluate the preventive effect of low‑dose dexamethasone on postoperative pain intensity, after obtaining written informed consent, patients will receive 10 mg of intravenous metoclopramide as premedication upon arrival in the operating room. Two 18‑gauge intravenous catheters will then be inserted into the upper extremities, followed by preload hydration with warmed Ringer’s lactate solution (using a fixed fluid warmer for one hour, without the use of an in‑line warming device) at a dose of 10 mL/kg over 30 minutes.Spinal anesthesia will be performed at the L4–L5 intervertebral space in the sitting position, using a 26‑gauge Quincke spinal needle via the paramedian approach. All patients will receive 2.5 mL of 0.5% hyperbaric bupivacaine administered intrathecally.Immediately after completion of spinal anesthesia, the intervention drug consisting of 2 mg intravenous dexamethasone (manufactured by Iran Darou Pharmaceutical Company), diluted in a syringe containing normal saline (0.9%), will be administered slowly over approximately one minute via the intravenous route.To maintain blinding, all study medications will be prepared according to the randomization list by an anesthesiologist not involved in the execution of the study and will be provided to the study administrator in identical, coded syringes for administration. Intervention Group 2 (Intravenous dexamethasone 4 mg):In this group, aiming to evaluate the preventive effect of a moderate dose of dexamethasone on postoperative pain intensity, after obtaining informed consent, patients receive 10 mg of intravenous metoclopramide as premedication upon arrival in the operating room. Subsequently, two 18G intravenous catheters are inserted in the upper limbs, and preload with warmed Ringer’s lactate solution (10 mL/kg over 30 minutes) is performed.Spinal anesthesia is performed at the L4–L5 intervertebral space in the sitting position using a 26G Quincke needle via the paramedian approach, and 2.5 mL of 0.5% hyperbaric bupivacaine is injected.Immediately after spinal anesthesia, 4 mg of injectable dexamethasone sodium phosphate (a clear, colorless solution with a concentration of 4 mg/mL) is administered as a single intravenous dose, injected slowly over approximately one minute. The dexamethasone used is a commercially available product manufactured by Iran Darou Pharmaceutical Company.The medication is prepared by an anesthesiologist not involved in the research team, using identical syringes diluted with normal saline and coded to ensure complete blinding. Throughout the study, the drug is administered only once, with no repeated dosing. Intervention Group 3 (Intravenous dexamethasone 6 mg):In this group, aiming to evaluate the analgesic and anti‑inflammatory effects of a high dose of dexamethasone, after obtaining informed consent, patients receive 10 mg of intravenous metoclopramide as premedication upon arrival in the operating room. Subsequently, two 18G intravenous catheters are inserted in the upper limbs, and preload with warmed Ringer’s lactate solution at a dose of 10 mL/kg over 30 minutes is performed.Spinal anesthesia is carried out at the L4–L5 intervertebral space in the sitting position using a 26G Quincke needle via the paramedian approach, followed by injection of 2.5 mL of 0.5% hyperbaric bupivacaine.Immediately after spinal anesthesia, 6 mg of injectable dexamethasone sodium phosphate (a clear, colorless solution with a concentration of 4 mg/mL) is administered as a single intravenous dose, injected slowly over approximately one minute. The dexamethasone used is a commercially available preparation manufactured by Iran Darou Pharmaceutical Company.All study medications are prepared by an anesthesiologist not involved in the research team, using identical syringes diluted with normal saline and coded, in order to ensure complete triple blinding. The study drug is administered only once, with no repeated dosing during the trial. Intervention Group 4 (Intravenous paracetamol 1 g):In this group, aiming to evaluate the preventive effect of paracetamol on postoperative pain intensity following cesarean section, after obtaining informed consent, patients receive 10 mg of intravenous metoclopramide as premedication upon arrival in the operating room. Subsequently, two 18G intravenous catheters are inserted in the upper limbs, and preload with warmed Ringer’s lactate solution at a dose of 10 mL/kg over 30 minutes is performed.Spinal anesthesia is performed similarly to the other groups at the L4–L5 intervertebral space in the sitting position using a 26G Quincke needle via the paramedian approach, followed by injection of 2.5 mL of 0.5% hyperbaric bupivacaine.Then, 15 minutes before the start of cesarean surgery, 1 g of intravenous paracetamol (acetaminophen), provided as a ready-to-use injectable solution containing 10 mg/mL paracetamol, diluted in 100 mL of normal saline, is administered over 10–15 minutes using a microset infusion system. The paracetamol used is a commercially available product manufactured by Iran Darou Pharmaceutical Company.The study medication is prepared by an anesthesiologist not involved in the research team, using identical infusion sets and containers, diluted with normal saline and coded, to ensure complete blinding. The drug is administered only once during the study, with no repeated dosing. In the control group, after obtaining written informed consent, patients will receive 10 mg of intravenous metoclopramide as premedication upon arrival in the operating room. Two 18‑gauge intravenous catheters will be inserted into the upper extremities, and preload hydration with warmed Ringer’s lactate solution will be administered at a dose of 10 mL/kg over 30 minutes.Spinal anesthesia, identical to that performed in the other groups, will be administered at the L4–L5 intervertebral space using a 26‑gauge Quincke spinal needle via the paramedian approach, and 2.5 mL of 0.5% hyperbaric bupivacaine will be injected intrathecally.Following spinal anesthesia, patients in the control group will receive 100 mL of intravenous normal saline as a placebo, administered slowly over approximately one minute. This solution will be prepared in syringes identical in appearance to those used for the other study medications and coded in the same manner to maintain triple blinding. Postoperative pain intensity after cesarean section. Timepoint: Postoperative pain intensity using the Visual Analog Scale (VAS) will be assessed at baseline (before administration of the study intervention and prior to the start of surgery) and subsequently at 2, 4, 6, and 8 hours after surgery (following receipt of the intervention). Method of measurement: The primary variable (postoperative pain intensity) will be measured using the Visual Analogue Scale for pain assessment. This scale consists of a 10‑centimeter horizontal line with “no pain” marked at one end (score 0) and “the worst pain imaginable” at the other end (score 10).At each predefined postoperative time point (0, 2, 4, 6, and 8 hours after the cesarean section), the patient will indicate the intensity of pain by marking a point on the line corresponding to their perceived pain level. The score is obtained by measuring the distance in centimeters from the “no pain” anchor to the patient’s mark.Before surgery, all participants will be instructed on how to use the scale to ensure a consistent and valid understanding of pain rating across subjects. Esfahan University of Medical Sciences Approved 2025-10-25 Ethics Committee of Al-Zahra Medical Research Centers, Isfahan University of Medical Sciences Al-Zahra Research Centers Complex, Al-Zahra Hospital, Soffeh Street, Isfahan, Isfahan Province, Iran Isfahan Isfehan Iran (Islamic Republic of)