Efficacy of Preventive Ketamine on Postoperative Pain

Postoperative Pain Clinical Trial

Official title:

Efficacy of Preventive Ketamine on Postoperative Pain: A Randomized, Double-blind Trial of Patients Undergoing Laparoscopic Sleeve Gastrectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04908579
• Other study ID #: FMASU MD 87/ 2021
• Status: Recruiting
• Phase: Phase 4
• Start date: June 15, 2021
• Est. completion date: September 30, 2024

Study information

• Verified date: June 2024
• Source: Ain Shams University
• Contact: Ibrahim Mamdouh Esmat
• Phone: 01001241928
• Email: ibrahim_mamdouh[@]med.asu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• bupivacaine(intraperitoneally) and ketamine (intraperitoneally)
40 ml volume of bupivacaine 0.25% + ketamine 0.5 mg/kg distributed as 30 ml intraperitoneally and 10 ml as port site infiltration 10 ml normal saline 0.9% will be given intravenous.
• bupivacaine(intraperitoneally) and ketamine (intravenously)
40 ml volume of bupivacaine 0.25% only distributed as 30 ml intraperitoneally and 10 ml as port site infiltration 10 ml volume of ketamine 0.5 mg/kg intravenously will be given after delivering the gastric sleeve and before start closure of port sites.
• bupivacaine(intraperitoneally)
40 ml volume of bupivacaine 0.25% only distributed as 30 ml intraperitoneally and 10 ml as port site infiltration 10 ml normal saline 0.9% will be given intravenous.

Locations

Country	Name	City	State
Egypt	Ain-Shams University Hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first given rescue analgesia(minutes)	Time to first given rescue analgesia(minutes)	24 hours postoperatively