Analgesia Effects of Intravenous Ketamine After Spinal Anesthesia for Non-elective Cesarean Section

B.P. Koirala Institute of Health Sciences

Status and phase: Completed; Phase 4

Conditions: Non Elective Cesarean Section and Ketamine Analgesia

Treatments: Drug: Ketamine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03450499

IRC/1089/017

Details and patient eligibility

About

This randomized double blind study will be conducted in pregnant woman planned for non elective cesarean section under spinal anesthesia. Ketamine group will receive intravenous 0.25 mg/kg and placebo group will receive same amount of normal saline after spinal anesthesia prior to skin incision. Postoperative outcomes measures are total opioid consumption and pain scores for 24 hrs.

Enrollment: 80 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• • All women at term(>or =37 weeks of gestation)

  • Healthy
  • American Society of Anesthesiologists(ASA) class1 and 2
  • Women undergoing non-elective caesarean section whose anesthetic plan is for spinal anesthesia with bupivacaine and fentanyl

Exclusion criteria

• • Women with American society of anesthesiologist physical status>2

  • Body mass index >or =40 kg per square meter
  • Height <150 cm
  • Any contraindication to the spinal anesthesia
  • History of substance abuse
  • History of hallucinations
  • Chronic opioid therapy
  • Chronic pain or on any pain medication currently
  • Patient with maternal complications,like cardiovascular disease pre-eclampsia,diabetes,multiple gestation,known fetal abnormality
  • Cases with severely compromised fetus where immediate administration of general anesthesia is required.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

analgesic effects of ketamine

Experimental group

Description:

the experimental group will receive ketamine intravenously at 0.25 mg per kg before skin incision.

Treatment:

Drug: Ketamine

placebo

Placebo Comparator group

Description:

they will receive same volume of 0.9% normal saline as calculated for experimental group before skin incision.

Treatment:

Drug: Placebo