Epidural Steroids With Intrathecal Nalbuphine for Lower Abdominal Oncologic Surgery

Mansoura University

Status: Completed

Conditions: Lower Abdominal Oncologic Surgery

Treatments: Drug: Dexamethasone-nalbuphine; Drug: Placebo-nalbuphine

Study type: Interventional

Funder types: Other

Identifiers

NCT03276325

R/17.04.127

Details and patient eligibility

About

Intraoperative pain, nausea, vomiting, hypotension, bradycardia are known side effects during lower abdominal surgery under spinal anesthesia, Time to 2 segment regression of sensory block and duration of effective analgesia prolonged with intrathecal (IT) 0.4 mg nalbuphine & IT 0.8 mg nalbuphine, but the incidence of side-effects was significantly higher with IT 0.8 mg nalbuphine compared with (IT) 0.4 mg nalbuphine.

Full description

So, the hypothesis of using IT nalbuphine mid away dose 0.6 mg between the best intraoperative analgesic effective dose 0.8 mg and the least side effect producing dose 0.4mg with the addition of epidural dexamethasone could augment the postoperative analgesia and reduce the unwanted side effects. Epidural dexamethasone in a full dose of 8 mg is probably more effective than lower doses to control moderate to severe post-operative pain. Dexamethasone 8mg dose is surgically safe neither produced delayed wound healing nor elevated blood glucose level.

Enrollment: 70 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• American Society of Anesthesiologists physical class I or II.
• Undergoing laparotomy
• Undergoing oophorectomy
• Undergoing hysterectomy
• Undergoing rectal mass excision

Exclusion criteria

• Patient refusal.
• Hypersensitivity to amide local anesthetics.
• General contraindications to spinal anesthesia.
• Cardiac diseases.
• Hepatic failure.
• Renal failure.
• Respiratory failure.
• Communication barriers.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups, including a placebo group

Placebo-nalbuphine

Placebo Comparator group

Description:

Epidural injection of normal saline followed with intrathecal injection of 0.6 mg nalbuphine in conjunction with 4 ml of hyperbaric bupivacaine 0.5%

Treatment:

Drug: Placebo-nalbuphine

Dexamethasone-nalbuphine

Active Comparator group

Description:

Epidural injection of dexamethasone followed with intrathecal injection of 0.6 mg nalbuphine in conjunction with 4 ml of hyperbaric bupivacaine 0.5%

Treatment:

Drug: Dexamethasone-nalbuphine