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

Phase 4

Completed

• Conditions: Non Elective Cesarean Section and Ketamine Analgesia
• Interventions: Drug: Placebo; Drug: Ketamine

• Registration Number: NCT03450499
• Lead Sponsor: B.P. Koirala Institute of Health Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-18
• Study First Submitted QC: 2018-02-28
• Study First Posted: 2018-03-01
• Study Start: 2018-04-01
• Primary Completion: 2019-03-07
• Study Completion: 2019-03-07
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-19
• Last Update Posted: 2019-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	they will receive same volume of 0.9% normal saline as calculated for experimental group before skin incision.
analgesic effects of ketamine	Ketamine	the experimental group will receive ketamine intravenously at 0.25 mg per kg before skin incision.

Primary Outcome Measures

Name	Time	Method
Total opioid requirement postoperatively	24 hrs	Total opioid required up to 24 postoperatively in ketamine and placebo group.

Secondary Outcome Measures

Name	Time	Method
Time to first perception of pain	24 hrs	Time to first perception of pain
Incidence of side effects	24 hrs	Incidence of post operative nausea and vomiting, shivering, sedation scores, side effects related to ketamine during the first 24h
Postoperative numerator rating scores(NRS)up to 24 hrs . postoperative )	24 hrs	• Postoperative NRS Scores (on arrival to Post operative care unit), 2, 4, 6, 8, 12 and 24 h ).The NRS ranges from 0- 10 and 0 refers to no pain and 10 means extreme possible pain perceived.

Trial Locations

Locations (1)

BP Koirala Institute of Health Sciences (BPKIHS); 🇳🇵 Dharān Bāzār, Koshi, Nepal