Effect of IV Nalbuphine on Nausea and Vomiting Following Intrathecal Morphine

Assiut University

Status: Not yet enrolling

Conditions: Inguinal Hernia

Treatments: Drug: nalbuphine on N and V and pain with intrathecal morphine onInguinal hernia repair surgery. randomized, prospective, double blinded and placebo-controlled trial study.

Study type: Interventional

Funder types: Other

Identifiers

NCT05704673

17101956

Details and patient eligibility

About

the study aimed to investigate the effect of Iv nalbuphine on postoperative nausea and vomiting and pain with intrathecal morphine on inguinal hernia repair surgery.

Full description

Bupivacaine hydrochloride is a commonly used local anesthetic in spinal anesthesia, however, the duration of spinal analgesia by bupivacaine is limited to about 75- 150 minutes.2 Therefore, various additives have been used with bupivacaine to prolong its effects and improve the quality of analgesia.(1) Opioids are the most popular used adjuvants added to bupivacaine in spinal blockade to obtain a sufficient intraoperative visceral analgesia and increase the duration and quality of postoperative analgesia, with less sympathetic block and hemodynamic effect .(2) morphine is commonly used for analgesia, but is frequently associated with postoperative nausea and vomiting (PONV) and pruritus, These side effects may lead to patient discomfort and prolonged hospital stay thus limiting the usefulness of IT morphine.

Nalbuphine is a mu receptor antagonist and a ĸappa receptor agonist.10 When added as an adjunct to intrathecal local anesthetics, it provides good analgesia with decreased incidence and severity of mu receptor side effects(3) Morphine binds most readily to the mu-opioid receptor and less well to the kappa-opioid receptor. So, the undesirable adverse events of morphine are thought to result from agonism at the mu-opioid receptor.5 Many drugs have been tried with morphine to potentiate its analgesic effects or to reduce the adverse events.6 Nalbuphine is a mixed opioid agonist-antagonist that acts mainly through kappa-opioid receptors, and it may attenuate mu-opioid receptor related side effects.3 Moreover, recent studies suggested that the analgesic effects of morphine and nalbuphine may be additive.

The addition of nalbuphine to intrathecal bupivacaine plus morphine significantly reduced the incidence and severity of postoperative nausea and vomiting and pruritus without affecting analgesic potency..(4)

Enrollment: 80 estimated patients

Sex: Male

Ages: 15 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• patients of aged 15-70years old
• males
• Scheduled patients for inguinal hernia repair surgery with under spinal anesthesia.
• ASA grade 1,2
• normal cardiac and renal function

Exclusion criteria

• Patient refusal
• Allergy to the studied drugs.
• Patients with contraindications to spinal anesthesia
• ASA grade 3,4

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

80 participants in 2 patient groups, including a placebo group

group (1)

Active Comparator group

Description:

who given intrathecal morphine thin IV nalbuphine and asize of 80 patients

Treatment:

Drug: nalbuphine on N and V and pain with intrathecal morphine onInguinal hernia repair surgery. randomized, prospective, double blinded and placebo-controlled trial study.

group (2)

Placebo Comparator group

Description:

who given intrathecal morphine onInguinal hernia druing spinal anathesia

Treatment:

Drug: nalbuphine on N and V and pain with intrathecal morphine onInguinal hernia repair surgery. randomized, prospective, double blinded and placebo-controlled trial study.