Clinical trial NCT06114472: The Impact of Preoperative Aromatherapy Upon Time to First Analgesia Request After Cesarean Section
Official title: The Impact of Preoperative Aromatherapy Upon Time to First Analgesia Request and Consumption After Cesarean Section; Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-11-02
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: one of the main aims of anesthesia is to reduce postoperative pain. However, many drugs that are used for this purpose, especially opioids, have side effects such as respiratory distress, nausea, itching, and gastrointestinal bleeding

. Recent studies have indicated interest in using complementary therapies such as heat and cold therapy, hypnotism.

Detailed description: Pain is amongst the most common problems after surgery

(1). Pain is an unpleasant sensory and emotional experience, which is associated with the real or probably damage of tissue. Unrelieved postoperative pain in addition to creating fears in the surgical patients, it makes adverse psychological impact on them

* The uncontrolled postoperative pain will make a lot of acute and chronic effects, including systemic mediators, hypercoagulability, postoperative immunosuppression, and delayed wound healing
* So, one of the main aims of anesthesia is to reduce postoperative pain. However, many drugs that are used for this purpose, especially opioids, have side effects such as respiratory distress, nausea, itching, and gastrointestinal bleeding. Recent studies have indicated interest in using complementary therapies such as heat and cold therapy, hypnotism.

Eligibility criteria: Inclusion Criteria:

* Age between 20 and 40 years
* Body mass index (BMI) of 18-35 kg/m2
* Patients with the American Society of Anesthesiologists (ASA) physical status I/II,
* Patients scheduled for elective cesarean section.

Exclusion Criteria:

* Patient refusal

  * Allergy to local anaesthetics
  * Anosmia
  * Coagulopathy,
  * Chronic pain syndromes
  * Prolonged opioid medication
  * Patients who received any analgesic 24 h before surgery.

Primary outcomes:
measure: time to first analgesia request
timeFrame: 24 hours
Secondary outcomes:
measure: Total daily consumption of analgesia
timeFrame: 24 hours
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Emad Zarief Kamel Said
Study officials:
References:
citation: McQuay H, Derry S, Wiffen P, Moore A, Eccleston C. Postoperative pain management: number-needed-to-treat approach versus procedure-specific pain management approach. Pain. 2013 Jan;154(1):180. doi: 10.1016/j.pain.2012.10.007. Epub 2012 Oct 22. No abstract available.
citation: Gupta A, Kaur K, Sharma S, Goyal S, Arora S, Murthy RS. Clinical aspects of acute post-operative pain management & its assessment. J Adv Pharm Technol Res. 2010 Apr;1(2):97-108.
citation: Sheikhan F, Jahdi F, Khoei EM, Shamsalizadeh N, Sheikhan M, Haghani H. Episiotomy pain relief: Use of Lavender oil essence in primiparous Iranian women. Complement Ther Clin Pract. 2012 Feb;18(1):66-70. doi: 10.1016/j.ctcp.2011.02.003. Epub 2011 Mar 16.