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

Primary Purpose

Non Elective Cesarean Section and Ketamine Analgesia

Status
Completed
Phase
Phase 4
Locations
Nepal
Study Type
Interventional
Intervention
Ketamine
Placebo
Sponsored by
B.P. Koirala Institute of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Elective Cesarean Section and Ketamine Analgesia

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

  • BP Koirala Institute of Health Sciences (BPKIHS)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

analgesic effects of ketamine

placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Total opioid requirement postoperatively
Total opioid required up to 24 postoperatively in ketamine and placebo group.

Secondary Outcome Measures

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.
Time to first perception of pain
Time to first perception of pain
Incidence of side effects
Incidence of post operative nausea and vomiting, shivering, sedation scores, side effects related to ketamine during the first 24h

Full Information

First Posted
February 18, 2018
Last Updated
August 19, 2019
Sponsor
B.P. Koirala Institute of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03450499
Brief Title
Analgesia Effects of Intravenous Ketamine After Spinal Anesthesia for Non-elective Cesarean Section
Official Title
Analgesia Effects of Intravenous Ketamine After Spinal Anesthesia for Non-elective Cesarean Section
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
March 7, 2019 (Actual)
Study Completion Date
March 7, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
B.P. Koirala Institute of Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Elective Cesarean Section and Ketamine Analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
analgesic effects of ketamine
Arm Type
Experimental
Arm Description
the experimental group will receive ketamine intravenously at 0.25 mg per kg before skin incision.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
they will receive same volume of 0.9% normal saline as calculated for experimental group before skin incision.
Intervention Type
Drug
Intervention Name(s)
Ketamine
Other Intervention Name(s)
ketamine hydrochloride
Intervention Description
the analgesic affects of ketamine will be compared between the experimental and placebo group.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
the analgesic requirement will be calculated in placebo group.
Primary Outcome Measure Information:
Title
Total opioid requirement postoperatively
Description
Total opioid required up to 24 postoperatively in ketamine and placebo group.
Time Frame
24 hrs
Secondary Outcome Measure Information:
Title
Postoperative numerator rating scores(NRS)up to 24 hrs . postoperative )
Description
• 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.
Time Frame
24 hrs
Title
Time to first perception of pain
Description
Time to first perception of pain
Time Frame
24 hrs
Title
Incidence of side effects
Description
Incidence of post operative nausea and vomiting, shivering, sedation scores, side effects related to ketamine during the first 24h
Time Frame
24 hrs

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
BP Koirala Institute of Health Sciences (BPKIHS)
City
Dharān Bāzār
State/Province
Koshi
ZIP/Postal Code
56700
Country
Nepal

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34193480
Citation
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.
Results Reference
derived

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

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