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

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.

Study Overview

• Status: Completed
• Conditions: Non Elective Cesarean Section and Ketamine Analgesia
• Intervention / Treatment: Drug: Ketamine; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• Nepal
  • Koshi
    • Dharān Bāzār, Koshi, Nepal, 56700
      • BP Koirala Institute of Health Sciences (BPKIHS)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: analgesic effects of ketamine; the experimental group will receive ketamine intravenously at 0.25 mg per kg before skin incision.	Drug: Ketamine; the analgesic affects of ketamine will be compared between the experimental and placebo group.; Other Names: ketamine hydrochloride
Placebo Comparator: placebo; they will receive same volume of 0.9% normal saline as calculated for experimental group before skin incision.	Drug: Placebo; the analgesic requirement will be calculated in placebo group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total opioid requirement postoperatively	Total opioid required up to 24 postoperatively in ketamine and placebo group.	24 hrs

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative numerator rating scores(NRS)up to 24 hrs . postoperative )	• 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.	24 hrs
Time to first perception of pain	Time to first perception of pain	24 hrs
Incidence of side effects	Incidence of post operative nausea and vomiting, shivering, sedation scores, side effects related to ketamine during the first 24h	24 hrs

Collaborators and Investigators

• Sponsor: B.P. Koirala Institute of Health Sciences

Publications and helpful links

General Publications

• Adhikari P, Subedi A, Sah BP, Pokharel K. Analgesic effects of intravenous ketamine after spinal anaesthesia for non-elective caesarean delivery: a randomised controlled trial. BMJ Open. 2021 Jun 30;11(6):e044168. doi: 10.1136/bmjopen-2020-044168.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Actual): March 7, 2019
• Study Completion (Actual): March 7, 2019

Study Registration Dates

• First Submitted: February 18, 2018
• First Submitted That Met QC Criteria: February 28, 2018
• First Posted (Actual): March 1, 2018

Study Record Updates

• Last Update Posted (Actual): August 20, 2019
• Last Update Submitted That Met QC Criteria: August 19, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Agnosia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Ketamine
• Other Study ID Numbers: IRC/1089/017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No