Comparison Between Ketamine Intrathecal and iv Dexamethasone for Post Cesarean Analgesia

May 8, 2024 updated by: Rokaya Mahmoud Khalifa, Assiut University

A Comparison Of Intrathecal Ketamine Versus Intravenous Dexamethasone For Postoperative Analgesia In Parturients Undergoing Spinal Anaesthesia For Cesarean Section: A Randomised Trial

The aim of our study is to compare the postoperative analgesic efficacy of intrathecal ketamine added to bupivacaine to that of intravenous dexamethasone in patients undergoing cesarean section under bupivacaine spinal anesthesia.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Caesarean delivery is associated with postoperative pain that may influence recovery, psychological maternal well-being, and breastfeeding Multimodal analgesic regimen including an intrathecal long-acting opioid, non-steroidal anti-inflammatory drugs, and acetaminophen has been suggested to effectively control postoperative pain after caesarean delivery Intravenous dexamethasone is recommended in elective caesarean delivery to decrease postoperative pain. Several systematic reviews and meta-analyses have examined the efficacy of dexamethasone after caesarean delivery and reported decreased postoperative pain and prolonged time to first analgesia In the same context, a meta-analysis of randomized controlled trials in humans suggests that there may be a benefit to using intrathecal ketamine as an adjunct to bupivacaine to improve postoperative pain after cesarean section . The mechanisms of action of intrathecal ketamine are incompletely understood. One study reports that ketamine's high lipophilicity allows for rapid diffusion into the venous system, namely through the azygos vein.

The following parameters will be monitored intraoperatively every 5 min:

  • HR, SBP, DBP, and MAP and SpO2 and documented every 15 min. till the end of surgery.
  • Any hemodynamic response to skin incision and to subsequent surgical steps will be documented.
  • For maintaining HR or systolic in range of more or less than 20% of baseline intraoperatively, ephedrine and intravenous fluids will be used . No other analgesic will be given intraoperatively.
  • primperan 0.1 mg/kg will be given at the end of the procedure to all patients.
  • All patients will receive 20 iu of oxytocin more till 40 iu or any ueterotonic drugs ( papal,methylergometrine) if needed .
  • Postoperative pain will be assessed using an 11-point (0=no pain and 10=worst pain) numeric rating scale (NRS). NRS for pain at rest and when coughing will be assessed serially at 1, 2, 4, 8, 16 and 24 h after surgery. The assessor and the patients will be unaware of the type of intervention received.
  • Time for first analgesic request and NRS at first analgesic request will be recorded. The duration of analgesia will be evaluated as the time from block administration to the time at which patient complained of pain or NRS ≥4 on assessment at serial intervals and nalurphine will be used as rescue analgesia . Total doses of analgesics required in the first 24 h will be recorded.
  • The presence of postoperative nausea and vomiting during the first 24 h will be recorded. Postoperative nausea or vomiting will be treated with 0.1 mg/kg of ondansetron. If the patient did not respond to ondansetron, then metoclopramide 10 mg will be given IV. Occurrence of any complications such as sedation ,nystagmus ,dizziness will be assessed

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age between 18 and 45 years
  • Body mass index (BMI) of 18-35 kg/m2
  • Patients with the American Society of Anesthesiologists (ASA) physical status I/II,
  • Patients scheduled for elective cesarean section .
  • females. .

Exclusion Criteria:

  • Patient refusal
  • Allergy to local anaesthetics
  • Infection at the site of injection
  • Coagulopathy,
  • Chronic pain syndromes
  • Prolonged opioid medication
  • Patients who received any analgesic 24 h before surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
will include 30 patients, will receive intrathecal bupivacaine 10mg , ,2mg morphine.
Active Comparator: Ketamine group
will include 30 patients, will receive intrathecal bupivacaine 10 mg , ,2 mg morphine, ,1 mg/kg ketamine .
Drug: Ketamine
. Standard monitoring procedures will include pulse oximetry, electrocardiography, and noninvasive arterial pressure prior to anesthetic induction. All patients will be premedicate antibiotic prophylaxis, according to the hospital's protocol. Anesthesia will be induced with intrathecal bupivacaine 10mg and ,1 mg/kg ketamine added in group A under sterile condition
Active Comparator: Dexamethasone group
will include 30 patients , will receive intrathecal bupivacaine 10 mg , ,2 mg morphine , intravenous dexamethasone 8mg .
Drug: dexamethasone
. Standard monitoring procedures will include pulse oximetry, electrocardiography, and noninvasive arterial pressure prior to anesthetic induction. All patients will be premedicate antibiotic prophylaxis, according to the hospital's protocol. Anesthesia will be induced with intrathecal bupivacaine 10mg and iv dexamethasone will be added

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
first call for analgesia
Time Frame: 24 hours
The first call for analgesia (the elapsed time from the time of spinal anaesthesia until the first postoperative analgesic use after the end of the surgery, which will be administrated based on patient request).
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
nausea & vomiting
Time Frame: 24 hours
Incidence of Postoperative nausea & vomiting (PONV) 24 hours postoperatively.
24 hours
analgesic requirement
Time Frame: 24 hours
The total analgesic requirement in 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: nagwa mo ibraheem, prof, assuit study

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2024

Primary Completion (Estimated)

December 15, 2024

Study Completion (Estimated)

December 20, 2024

Study Registration Dates

First Submitted

November 27, 2023

First Submitted That Met QC Criteria

May 8, 2024

First Posted (Actual)

May 10, 2024

Study Record Updates

Last Update Posted (Actual)

May 10, 2024

Last Update Submitted That Met QC Criteria

May 8, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • comparison

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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