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Postoperative analgesic efficacy of intrathecal Nalbuphine with Bupivacaine in spinal anesthesia for anorectal surgery : A randomized controlled trial

Postoperative analgesic efficacy of intrathecal Nalbuphine with Bupivacaine in spinal anesthesia for anorectal surgery : A randomized controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000527561
Enrollment
35
Registered
2024-04-28
Start date
2023-09-22
Completion date
2024-04-30
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

- primary hypothesis : patients undergoing elective anorectal surgery under spinal anesthesia with 0.5% hyperbaric bupivacaine 7.5-10 mg with spinal Nalbuphine 0.3 mg will have lesser pain score than controlled group -secondary hypothesis : spinal anesthesia with 0.5% hyperbaric bupivacaine 7.5-10 mg with spinal Nalbuphine group will have the same incidence of adverse effects and complication such as nausea, vomitting, pruritus, sedative effect and urinary retention as contolled group

Interventions

0.5% hyperbaric bupivacaine 1.5-2ml (7.5-10 mg) mixed with Nalbuphine 0.3 mg intrathecal (intervention) intrathecal by anesthetist or anesthesia resident once only just before surgery (dose based on Gudaityte J, Marchertiene I, Pavalkis D, Saladzinskas Z, Tamelis A, Toker I. Minimal effective dose of spinal hyperbaric bupivacaine for adult anorectal surgery: a prospective, double-blinded, randomized study: A-362. European Journal of Anaesthesiology | EJA. 2005;22:96.))

Sponsors

Nantapat Soonthonnitikul
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

1. patients under going elective anorectal surgery under spinal anesthesia at King Chulalongkorn Memorial Hospital age from 18 to 65 year old 2. American Society of Anesthesiologists Physical Status I to II 3. patients consented to participate in our research

Exclusion criteria

1. patients that have history of allergy to research drugs 2. patients that can't report their pain score 3. patients with history of chronic pain (more than 3 months) and have history of morphine use 4. patients with skin disease or preopearive pruritic symptoms 5. patients that require postoperative intentive care unit 6. patients contraindicated to spinal anesthesia

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026