Clinical trial NCT03018301: Intravenous Ketamine and Postoperative Pain Following Cesarean Section.
Official title: Effect of Single Intravenous Ketamine Dose on Postoperative Pain Following Cesarean Section Under Spinal Anesthesia: A Randomized Control Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Postoperative Pain
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-01-12
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the analgesic effect of low-dose intravenous ketamine in pregnant mothers undergoing cesarean section under Bupivacaine spinal anesthesia.

Detailed description: * No premedication will be given, and patients will be monitored by electrocardiogram, non-invasive arterial blood pressure, and pulse oximetry when they entered the operating room.
* 18 gauge IV cannula will be inserted and all patients will be preloaded with 10 ml/kg of lactate ringer over 20 min period.
* All participants will have spinal anesthesia using bupivacaine. The dose of the drug, as well as the method of injection will be identical for all individuals; 10 mg (2 cc 0.5%), in the L4-L5 space using needle 25 G, midline, with the patient in a sitting position.
* After administering bupivacaine, and prior to surgery the height of the sensory block will be assessed bilaterally (complete loss of sensation to ice) in a ascending fashion starting from T12 dermatome.
* Once adequate anesthesia to at least T6 dermatome will be achieved, the operation will be allowed to begin. When systolic blood pressure decrease to \< 90 mmHg, or 30% of the pre-anesthetic blood pressure, it will be corrected by administering 5 mg ephedrine.
* Patients will be asked to report any intraoperative pain using visual pain score(VPS)of 0(no pain) 10(worst pain).

Eligibility criteria: Inclusion Criteria:

* Eligible women ASA class 1 and 2, are at term (≥37 week gestation), Scheduled for elective cesarean section whose anesthetic plan is for spinal anesthesia with Bupivacaine and intravenous pethidine and paracetamol for post operative analgesia.

Exclusion Criteria:

* • Body mass index ≥40 kg/m2,

  * Known allergy to any of the study medications,
  * Contraindication to the spinal anesthesia,
  * History of substance abuse,
  * History of hallucinations,
  * Chronic opioid therapy,
  * Chronic pain.

Primary outcomes:
measure: • Number of Subjects Requiring Supplemental Analgesia
timeFrame: 24 hours postoperative
Secondary outcomes:
measure: Cumulative morphine/paracetamol
timeFrame: 24 hours postoperative
measure: Number of subjects reporting nausea, vomiting
timeFrame: 24 hours postoperative
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university faculty of medicine
Study officials:
affiliation: Assiut University
name: Israa M Sayed
role: STUDY_CHAIR
References:
citation: El-Tahan MR, Warda OM, Yasseen AM, Attallah MM, Matter MK. A randomized study of the effects of preoperative ketorolac on general anaesthesia for caesarean section. Int J Obstet Anesth. 2007 Jul;16(3):214-20. doi: 10.1016/j.ijoa.2007.01.012. Epub 2007 Apr 24.