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Comparison Between Ketamine Intrathecal and iv Dexamethasone for Post Cesarean Analgesia

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

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06408974
Enrollment
90
Registered
2024-05-10
Start date
2024-12-01
Completion date
2024-12-20
Last updated
2024-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Cesarean Analgesia

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.

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

Interventions

DRUGKetamine

. 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

DRUGdexamethasone

. 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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
first call for analgesia24 hoursThe 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).

Secondary

MeasureTime frameDescription
nausea & vomiting24 hoursIncidence of Postoperative nausea & vomiting (PONV) 24 hours postoperatively.
analgesic requirement24 hoursThe total analgesic requirement in 24 hours

Contacts

Primary Contactrokaya ma khalifa, resident
Rokayakhalifa495@gmail.com01013940535
Backup Contactmostafa sa abbas, dr
mostafasamy@aun.edu.eg01003060187

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026