Comparison of the effects of epidural gelfoam soaked in bupivacaine and intramuscular paravertebral bupivacaine on postoperative analgesia after lumbar spine surgeries
Comparison of the effects of epidural gelfoam soaked in bupivacaine and intramuscular paravertebral bupivacaine on postoperative analgesia after lumbar spine surgeries
Design
A randomized, double-blind, parallel-group, Phase 3 clinical trial will be conducted in 60 patients. Randomization will be performed using block randomization method using Random allocation software.
Settings and conduct
This study will be conducted on patients undergoing lumbar spine surgery with general anesthesia in Urmia Imam Khomeini Hospital. For patients in the first group, a 1 × 5 cm strip of gelfoam soaked in 70 mg of 0.25% bupivacaine will be placed in the epidural space 30 minutes before wound closure following laminectomy. For patients in the second group, 70 mg of 0.25% bupivacaine will be injected intramuscularly paravertebrally 30 minutes before wound closure. The study will be conducted as a single-blind clinical trial, and patients will be unaware of their assignment to one of the intervention groups.
Participants/Inclusion and exclusion criteria
In this study, 60 patients aged 18 to 65 years undergoing lumbar spine surgery under general anesthesia will be included. The main exclusion criteria include patients with a body mass index (BMI) over 30 kg/m2, a history of seizures, severe systemic disease, coagulation disorders, and drug abusers.
Intervention groups
For patients in the first group, a 1 × 5 cm strip of gelfoam soaked in 70 mg of 0.25% bupivacaine will be placed in the epidural space 30 minutes before wound closure following laminectomy. For patients in the second group, 70 mg of 0.25% bupivacaine will be injected intramuscularly paravertebrally 30 minutes before wound closure.
Main outcome variables
Pain severity; time of first request for analgesic medication; dosage of morphine analgesic medication.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230520058233N1
Registration date:2023-07-11, 1402/04/20
Registration timing:prospective
Last update:2023-07-11, 1402/04/20
Update count:0
Registration date
2023-07-11, 1402/04/20
Registrant information
Name
Peyman Gholipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3346 9931
Email address
gholipour.p@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-23, 1402/06/01
Expected recruitment end date
2024-02-19, 1402/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of epidural gelfoam soaked in bupivacaine and intramuscular paravertebral bupivacaine on postoperative analgesia after lumbar spine surgeries
Public title
The effects of epidural gelfoam soaked in bupivacaine and intramuscular paravertebral bupivacaine on postoperative analgesia after lumbar spine surgeries
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing lumbar spine surgery with general anesthesia
Age between 18 and 65 years old
Patients with physical status one and two according to the criteria of the American Anesthesia Association (ASA I, II)
Exclusion criteria:
Body mass index above 30 kg/m2
History of seizure disorder
Severe systemic disease
Coagulation disorders
Drug abusers
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be assigned to two groups using the Block Randomization method based on generated-numbers by the Random Allocation computer software. In this software, the number of groups and the total sample size will be entered first, and then the Block randomization method will be implemented in the block section. Therefore, based on the total sample size (60 patients), 15 blocks of four will be used.
Blinding (investigator's opinion)
Single blinded
Blinding description
The study will be conducted as a single-blind clinical trial. The patients will be blind of their allocation in one of intervention groups. So, the table of computer-generated numbers will be given to the physician. The physician will enter the patients into groups according to the order of numbers.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Imam Khomeini Hospital, Urmia University of Medical Sciences.
In recovery and 6, 12 and 24 hours after the surgery
Method of measurement
Visual analogue scale (VAS)
2
Description
Time of first request for analgesic medication
Timepoint
In 24 hours after the surgery
Method of measurement
Time of request by the patient
3
Description
Dosage of morphine analgesic medication
Timepoint
In 24 hours after the surgery
Method of measurement
Miligeram
Secondary outcomes
1
Description
Mean arterial blood pressure
Timepoint
In recovery and 6, 12 and 24 hours after the surgery
Method of measurement
Monitoring by device
2
Description
Heart rate
Timepoint
In recovery and 6, 12 and 24 hours after the surgery
Method of measurement
Monitoring by device
Intervention groups
1
Description
Intervention group: For patients in the first group, a 1 × 5 cm strip of gelfoam soaked in 70 mg of 0.25% bupivacaine will be placed in the epidural space 30 minutes before wound closure following laminectomy.
Category
Treatment - Drugs
2
Description
Intervention group: For patients in the second group, 70 mg of 0.25% bupivacaine will be injected intramuscularly paravertebrally 30 minutes before wound closure.