Assessment of Gabapentin effect on postoperative pain, nausea, and vomiting in patients undergoing laparoscopic urology surgery
Design
A double-blind, randomized clinical trial study with parallel groups and phases 3 on 42 patients. Randomization will be done with the block randomization method using Random allocation software.
Settings and conduct
This study will be conducted on candidate patients for laparoscopic urology in Urmia Imam Khomeini Hospital. This study will be a double-blind study and the patient and the researcher who will evaluate the outcomes will be blinded to the allocation of patients into intervention or placebo groups.
Participants/Inclusion and exclusion criteria
In this study, 42 patients candidates for laparoscopic urology surgery, the aged 18 to 65 years, and class ASA I and II will be included. Patients with any coagulopathy and opium addiction will be excluded.
Intervention groups
Patients in the intervention group will receive a number 300 mg capsule of gabapentin 2 hours before surgery and a number 300 mg capsule daily until 48 hours after surgery (each patient will receive a total of three capsules). In the placebo group, they will receive the same number of placebo capsules.
Main outcome variables
The primary outcomes will include pain, nausea, and vomiting after surgery.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180625040232N9
Registration date:2022-05-27, 1401/03/06
Registration timing:prospective
Last update:2022-05-27, 1401/03/06
Update count:0
Registration date
2022-05-27, 1401/03/06
Registrant information
Name
Saman Farshid
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3346 9931
Email address
farshid.s@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-21, 1401/03/31
Expected recruitment end date
2022-12-21, 1401/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of Gabapentin effect on postoperative pain, nausea, and vomiting in patients undergoing laparoscopic urology surgery
Public title
Assessment of Gabapentin effect in patients undergoing laparoscopic urology surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients candidate for laparoscopic urology
Age between 18 and 65 years
Patients with physical status one and two according to the criteria of the American Anesthesia Association (ASA I, II)
Exclusion criteria:
Having any coagulopathy
Opium addiction
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into intervention or placebo groups using the block randomization method based on generated numbers by Random allocation software. Thus, in this software, first, the number of groups and the total determined sample size will be entered, and then in the block section, the Block randomization method will be implemented. Patients will be allocated to groups based on generated numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study will be conducted as a double-blind clinical trial. The patient and the researcher who will be evaluating the outcomes will be blind to the allocation of patients into intervention or placebo groups. Placebo capsules will be similar in shape and size to gabapentin capsules. Gabapentin and placebo capsules will be coded A and B.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Imam Khomeini University hospital- Urmia University of Medical Sciences
Urological procedure associated with injury or harm in therapeutic use
Primary outcomes
1
Description
Pain
Timepoint
6, 24, 12 and 48 hours after surgery
Method of measurement
Visual analogue scale (VAS)
2
Description
Nausea and vomiting
Timepoint
6, 24, 12 and 48 hours after surgery
Method of measurement
Post operative nausea and vomiting scale (PONV scale)
Secondary outcomes
1
Description
Dosage of analgesic
Timepoint
Up to 48 hours after surgery
Method of measurement
milligram
2
Description
Receiving anti-nausea and vomiting medicine
Timepoint
Up to 48 hours after surgery
Method of measurement
yes/ no
Intervention groups
1
Description
Intervention group: Patients in the intervention group will receive a number 300 mg capsule of gabapentin 2 hours before surgery and a number 300 mg capsule daily until 48 hours after surgery (each patient will receive a total of three capsules).
Category
Treatment - Other
2
Description
Control group: Patients in the placebo group will receive a number 300 mg capsule of placebo 2 hours before surgery and a number 300 mg capsule daily until 48 hours after surgery.