Efficacy of Preventive Ketamine on Postoperative Pain

Ain Shams University

Status and phase: Enrolling; Phase 4

Conditions: Postoperative Pain

Treatments: Drug: bupivacaine(intraperitoneally) and ketamine (intravenously); Drug: bupivacaine(intraperitoneally) and ketamine (intraperitoneally); Drug: bupivacaine(intraperitoneally)

Study type: Interventional

Funder types: Other

Identifiers

NCT04908579

FMASU MD 87/ 2021

Details and patient eligibility

About

• 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 21 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups

- GROUP (I): 30 patients

Active Comparator group

Treatment:

Drug: bupivacaine(intraperitoneally) and ketamine (intraperitoneally)

- GROUP (II): 30 patients

Active Comparator group

Treatment:

Drug: bupivacaine(intraperitoneally) and ketamine (intravenously)

- GROUP (III) (Control): 30 patients

Active Comparator group

Treatment:

Drug: bupivacaine(intraperitoneally)