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IRCT20190423043356N2 IRCT 2020-08-21 Mashhad University of Medical Sciences The effectiveness of enhanced recovery after surgery (ERAS) on pain severity in patients with acute appendicitis The effectiveness of enhanced recovery after surgery (ERAS) program compared to the usual protocol on pain severity in patients undergoing surgery for acute appendicitis 2020-03-20 anticipated 76 Complete https://irct.ir/trial/48647 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, individual randomization is used. The sequence of random numbers is generated using "Randomization.com" website with simple randomization method. Finally, the patients are divided into two separate groups by sealed, opaque and sequenced envelopes. N/A Acute appendicitis. Intervention 1: Intervention group: ERAS program A- Before surgery: limit fasting to 6 hours before surgery, consumption of carbohydrate fluids up to 2 hours before surgery, reducing opioid consumption, reducing the volume of fluid intake to normal volume (normovolemic); prescribing anti-emetic drugs before and after surgery to reduce nausea and vomiting, normal blood sugar during the protocol, avoiding of drain usage, B- Postoperative: early oral feeding immediately after becoming conscious, make the patient to walk as soon as possible to prevent from ileus, administration of non-opioid analgesics to reduce pain and ileus and improve nutrition C- Postoperative follow-up: Evaluation for complications of surgery including wound infection, need for readmission. Intervention 2: Control group: routine care before and after surgery which includes the following : using opioids to relieve pain, using drains such as a nasogastric tube (NG-tube), or Foley catheter, in case of needing to keep the patient in fasting situation (NPO). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Amin Dalili
Surgical Oncology Research Center, Imam Reza Hospital, Mashhad University of Medical Sciences
Mashhad Iran (Islamic Republic of) 91388-13944 +98 51 3180 2557 daliliam@mums.ac.ir Mashhad University of Medical Sciences scientific Amin Dalili
Surgical Oncology Research Center, Imam Reza Hospital, Mashhad University of Medical Sciences
Mashhad Iran (Islamic Republic of) 91388-13944 +98 51 3180 2557 daliliam@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Age between 18-65 Patients with acute appendicitis Patients undergoing surgery for acute appendicitis 18 years 65 years Both Appendicular peritonitis Appendicular abscess Appendicular phlegmon K35 Acute appendicitis Treatment - Other Treatment - Other Intervention group: ERAS program A- Before surgery: limit fasting to 6 hours before surgery, consumption of carbohydrate fluids up to 2 hours before surgery, reducing opioid consumption, reducing the volume of fluid intake to normal volume (normovolemic); prescribing anti-emetic drugs before and after surgery to reduce nausea and vomiting, normal blood sugar during the protocol, avoiding of drain usage, B- Postoperative: early oral feeding immediately after becoming conscious, make the patient to walk as soon as possible to prevent from ileus, administration of non-opioid analgesics to reduce pain and ileus and improve nutrition C- Postoperative follow-up: Evaluation for complications of surgery including wound infection, need for readmission Control group: routine care before and after surgery which includes the following : using opioids to relieve pain, using drains such as a nasogastric tube (NG-tube), or Foley catheter, in case of needing to keep the patient in fasting situation (NPO) Severity of postoperative pain. Timepoint: Once, 7 days after surgery. Method of measurement: Visual Analogue Scale (VAS scale). Postoperative Ileus. Timepoint: 30 days after surgery. Method of measurement: Physical examination. Hospitalization period. Timepoint: During admission. Method of measurement: Number of admission days. Postoperative complications. Timepoint: 30 days after surgery. Method of measurement: Physical examination. Mashhad University of Medical Sciences Approved 2020-01-28 Mashhad University of Medical Sciences Ethics Committee Ibn-e-sina street, Imam Reza Hospital Mashhad Razavi Khorasan Iran (Islamic Republic of)