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

• ClinicalTrials.gov Identifier: NCT03450499
• Recruitment Status: Completed
• First Posted: March 1, 2018
• Last Update Posted: August 20, 2019
• Sponsor: B.P. Koirala Institute of Health Sciences
• Information provided by (Responsible Party): prahlad adhikari, B.P. Koirala Institute of Health Sciences

Tracking Information

• First Submitted Date: February 18, 2018
• First Posted Date: March 1, 2018
• Last Update Posted Date: August 20, 2019
• Actual Study Start Date: April 1, 2018
• Actual Primary Completion Date: March 7, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 28, 2018)

Total opioid requirement postoperatively [ Time Frame: 24 hrs ]

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 18, 2018)

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

Original Secondary Outcome Measures (submitted: February 28, 2018)

• Postoperative numerator rating scores(NRS)up to 24 hrs . postoperative ) [ Time Frame: 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.
• Time to first opioid request [ Time Frame: 24 hrs ]
  Time to first opioid request
• Incidence of side effects [ Time Frame: 24 hrs ]
  Incidence of post operative nausea and vomiting, shivering, sedation scores, side effects related to ketamine during the first 24h

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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 Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Non Elective Cesarean Section and Ketamine Analgesia

Intervention

• Drug: Ketamine
  the analgesic affects of ketamine will be compared between the experimental and placebo group.
  Other Name: ketamine hydrochloride
• Drug: Placebo
  the analgesic requirement will be calculated in placebo group.

Study Arms

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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 28, 2018): 80
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: March 7, 2019
• Actual Primary Completion Date: March 7, 2019 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 35 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Nepal

Administrative Information

• NCT Number: NCT03450499
• Other Study ID Numbers: IRC/1089/017
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: prahlad adhikari, B.P. Koirala Institute of Health Sciences
• Original Responsible Party: Same as current
• Current Study Sponsor: B.P. Koirala Institute of Health Sciences
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: B.P. Koirala Institute of Health Sciences
• Verification Date: August 2019