NCT04908579 Efficacy of Preventive Ketamine on Postoperative Pain
| NCT ID | NCT04908579 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Ain Shams University |
| Condition | Postoperative Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2021-06-15 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 90 participants in total. It began in 2021-06-15 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
* Although bariatric surgery is mainly performed laparoscopically, analgesic optimization is still essential to reduce complications and to improve the patients' comfort. In laparoscopic sleeve gastrectomy, the intraoperative peritoneal instillation of bupivacaine hydrochloride (30 ml, 0.25%) was known to be safe and effective in reducing postoperative pain, nausea, and vomiting. * Furthermore, usage of ketamine both as a pre and post-operative pain management is well established. Ketamine can be used solely or in combination with other co-adjuvant drugs, increasing their efficacy. Many therapeutic properties of ketamine have been attributed to its antagonism mechanism to N-Methyl-D-aspartate receptors.
Eligibility Criteria
Inclusion Criteria: * \- Body mass index \> 35 and \< 60 kg/m2 * Either medically free or with well controlled hypertension and/or diabetes. Exclusion Criteria: * \- Patient's refusal to participate in the study * BMI \> 60 kg/m2. * Age less than 21 years. * Patients with severe systemic disease which is not life-threatening. * Patients on antipsychotics, antidepressants and/or corticosteroids. * Patients with history of obstructive sleep apnea. * Allergic reaction to any of the study medications.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04908579 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 60 Years, studying Postoperative Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04908579 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04908579 currently recruiting?
Yes, NCT04908579 is actively recruiting participants. Contact the research team at ibrahim_mamdouh@med.asu.edu.eg for enrollment information.
Where is the NCT04908579 trial being conducted?
This trial is being conducted at Cairo, Egypt.
Who is sponsoring the NCT04908579 clinical trial?
NCT04908579 is sponsored by Ain Shams University. The trial plans to enroll 90 participants.