Intrathecal Morphine for Postoperative Analgesia Following Laparoscopic Bariatric Surgery

Assiut University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Postoperative Pain

Treatments: Drug: intrathecal saline; Drug: intrathecal morphine

Study type: Interventional

Funder types: Other

Identifiers

NCT02731430

274

Details and patient eligibility

About

this study compares the use of intrathecal morphine, to multimodal analgesic techniques for postoperative pain management following laparoscopic bariatric surgery.

Enrollment: 100 patients

Sex: All

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• American Society of Anesthesia (ASA) II-III patients.
• Aged 30-50 years.
• The body mass index (BMI) of the patients needed to be over 40 kg/m² or over 35 kg/m² with at least one comorbidity.

Exclusion criteria

• Patients with a known allergy to the study drugs.
• Advanced cardiac, respiratory, renal or hepatic disease.
• Coagulation disorders.
• Infection at or near the site of intrathecal injection.
• Drug or alcohol abuse.
• Psychiatric illnesses that may interfere with perception and assessment of pain.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

group I: morphine group

Active Comparator group

Description:

received 0.3mg morphine (0.3ml) added to 1.2ml of bupivacaine 0.5% (total volume 1.5ml), intrathecally, immediately before induction of general anesthesia.

Treatment:

Drug: intrathecal morphine

group II: control group

Placebo Comparator group

Description:

received 0.3ml saline added to 1.2mlof bupivacaine 0.5% (total volume 1.5ml), intrathecally, immediately before induction of general anesthesia.

Treatment:

Drug: intrathecal saline