Comparison Between Ketamine Intrathecal and iv Dexamethasone for Post Cesarean Analgesia

NCT06408974 | Not Yet Recruiting Phase 4

• 1 other identifier: comparison
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Post Cesarean Analgesia

Outcome Measures

Primary Outcomes (1)

• first call for analgesia

  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 Outcomes (2)

• nausea & vomiting

  24 hours

• analgesic requirement

  24 hours

Study Arms (3)

Control group

NO INTERVENTION

will include 30 patients, will receive intrathecal bupivacaine 10mg , ,2mg morphine.

Ketamine group

ACTIVE COMPARATOR

will include 30 patients, will receive intrathecal bupivacaine 10 mg , ,2 mg morphine, ,1 mg/kg ketamine .

Drug: Ketamine

Dexamethasone group

ACTIVE COMPARATOR

will include 30 patients , will receive intrathecal bupivacaine 10 mg , ,2 mg morphine , intravenous dexamethasone 8mg .

Drug: dexamethasone

Interventions

Ketamine DRUG

. 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

Ketamine group

dexamethasone DRUG

. 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

Dexamethasone group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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. .

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (6)

• Gamez BH, Habib AS. Predicting Severity of Acute Pain After Cesarean Delivery: A Narrative Review. Anesth Analg. 2018 May;126(5):1606-1614. doi: 10.1213/ANE.0000000000002658.

  PMID: 29210789 RESULT

• Bornstein E, Husk G, Lenchner E, Grunebaum A, Gadomski T, Zottola C, Werner S, Hirsch JS, Chervenak FA. Implementation of a Standardized Post-Cesarean Delivery Order Set with Multimodal Combination Analgesia Reduces Inpatient Opioid Usage. J Clin Med. 2020 Dec 22;10(1):7. doi: 10.3390/jcm10010007.

  PMID: 33375192 RESULT

• Heesen M, Rijs K, Hilber N, Eid K, Al-Oweidi A, Rossaint R, Klimek M. Effect of intravenous dexamethasone on postoperative pain after spinal anaesthesia - a systematic review with meta-analysis and trial sequential analysis. Anaesthesia. 2019 Aug;74(8):1047-1056. doi: 10.1111/anae.14666. Epub 2019 May 6.

  PMID: 31058317 RESULT

• Sohnen S, Dowling O, Shore-Lesserson L. Single dose perioperative intrathecal ketamine as an adjuvant to intrathecal bupivacaine: A systematic review and meta-analysis of adult human randomized controlled trials. J Clin Anesth. 2021 Oct;73:110331. doi: 10.1016/j.jclinane.2021.110331. Epub 2021 May 5.

  PMID: 33962333 RESULT

• Bion JF. Intrathecal ketamine for war surgery. A preliminary study under field conditions. Anaesthesia. 1984 Oct;39(10):1023-8. doi: 10.1111/j.1365-2044.1984.tb08895.x.

  PMID: 6496899 RESULT

• Ituk U, Thenuwara K. The effect of a single intraoperative dose of intravenous dexamethasone 8 mg on post-cesarean delivery analgesia: a randomized controlled trial. Int J Obstet Anesth. 2018 Aug;35:57-63. doi: 10.1016/j.ijoa.2018.03.008. Epub 2018 Mar 26.

  PMID: 29773484 RESULT

MeSH Terms

Interventions

Ketamine; Dexamethasone

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• nagwa mo ibraheem, prof

  assuit study

  PRINCIPAL INVESTIGATOR

Central Study Contacts

rokaya ma khalifa, resident

CONTACT

01013940535; Rokayakhalifa495@gmail.com

mostafa sa abbas, dr

CONTACT

01003060187; mostafasamy@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: May 10, 2024
• Study Start: December 1, 2024
• Primary Completion: December 15, 2024
• Study Completion: December 20, 2024
• Last Updated: May 10, 2024

Record last verified: 2024-05