Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000527561
Ethics application status
Approved
Date submitted
23/12/2023
Date registered
28/04/2024
Date last updated
28/04/2024
Date data sharing statement initially provided
28/04/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Postoperative analgesic efficacy of intrathecal Nalbuphine with Bupivacaine in
spinal anesthesia for anorectal surgery : A randomized controlled trial
Scientific title
Postoperative analgesic efficacy of intrathecal Nalbuphine with Bupivacaine in
spinal anesthesia for anorectal surgery : A randomized controlled trial
Secondary ID [1] 311143 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative pain after anorectal surgery 332361 0
Condition category
Condition code
Anaesthesiology 329070 329070 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.))
Intervention code [1] 327639 0
Treatment: Drugs
Comparator / control treatment
0.5% hyperbaric bupivacaine 1.5-2ml (7.5-10 mg) alone (current standard treatment) 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.))
Control group
Active

Outcomes
Primary outcome [1] 336894 0
postoperative pain score at rest
Timepoint [1] 336894 0
12 hours after administration of spinal anesthesia
Primary outcome [2] 337569 0
postoperative pain score on motion
Timepoint [2] 337569 0
12 hours after administration of spinal anesthesia
Secondary outcome [1] 430048 0
time to first analgesia required
Timepoint [1] 430048 0
From administration of spinal anaesthesia to 24 hours after spinal anaesthesia
Secondary outcome [2] 430049 0
types and amount of analgesia required after spinal anesthesia
Timepoint [2] 430049 0
From administration of spinal anaesthesia to 24 hours after spinal anaesthesia
Secondary outcome [3] 430051 0
possible adverse effects from spinal Nalbuphine (composite outcome)
Timepoint [3] 430051 0
From administration of spinal anaesthesia to 24 hours after spinal anaesthesia

Eligibility
Key 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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomized by computer
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
22/09/2023
Date of last participant enrolment
Anticipated
30/04/2024
Actual
Date of last data collection
Anticipated
30/04/2024
Actual
Sample size
Target
90
Accrual to date
35
Final
Recruitment outside Australia
Country [1] 26038 0
Thailand
State/province [1] 26038 0
Khet Pathum Wan

Funding & Sponsors
Funding source category [1] 315457 0
Self funded/Unfunded
Name [1] 315457 0
Nantapat Soonthonnitikul
Country [1] 315457 0
Thailand
Primary sponsor type
Individual
Name
Nantapat Soonthonnitikul
Address
1701 Chomfah village Rangsit-Nakornnayok 64 alley, Rangsit-Nakornnayok road, Prachatiput, Tanyaburi, Pathumtani 12130
Country
Thailand
Secondary sponsor category [1] 317525 0
None
Name [1] 317525 0
Address [1] 317525 0
Country [1] 317525 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314316 0
Institutional review boards, Faculty of Medicine, Chulalongkorn university
Ethics committee address [1] 314316 0
1873, Rama 4 Road, Pathumwan, Bangkok 10330
Ethics committee country [1] 314316 0
Thailand
Date submitted for ethics approval [1] 314316 0
21/07/2023
Approval date [1] 314316 0
22/08/2023
Ethics approval number [1] 314316 0
0393/66

Summary
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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131158 0
Dr Nantapat Soonthonnitikul
Address 131158 0
King Chulalongkorn Memorial Hospital, 1873 Rama IV Rd, Pathum Wan, Bangkok 10330
Country 131158 0
Thailand
Phone 131158 0
+66856999880
Fax 131158 0
Email 131158 0
[email protected]
Contact person for public queries
Name 131159 0
Nantapat Soonthonnitikul
Address 131159 0
King Chulalongkorn Memorial Hospital, 1873 Rama IV Rd, Pathum Wan, Bangkok 10330
Country 131159 0
Thailand
Phone 131159 0
+66856999880
Fax 131159 0
Email 131159 0
[email protected]
Contact person for scientific queries
Name 131160 0
Nantapat Soonthonnitikul
Address 131160 0
King Chulalongkorn Memorial Hospital, 1873 Rama IV Rd, Pathum Wan, Bangkok 10330
Country 131160 0
Thailand
Phone 131160 0
+66856999880
Fax 131160 0
Email 131160 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.