Determining and comparing the analgesic effect of erector spina block (ESP) and tap block (TAP) in pain after open inguinal hernia surgery.
Design
Clinical trial with parallel groups, three blind, randomized, on 28 patients. A lottery method will be used to assign patients to the first and second intervention groups.
Settings and conduct
The current study is a three-blind clinical trial study (patients will not be informed about the type and type of nerve block for pain control. The doctor evaluating pain and other variables will be unaware of each patient's group. The data analyst will be from the groups The intervention of uninformed patients will be done in 1403 in the city of Qom and in Shahid Beheshti Hospital, by a surgeon who will undergo hernia surgery.
Participants/Inclusion and exclusion criteria
Entry criteria: Those who were candidates for inguinal hernia repair surgery. Being between 20 and 65 years old.
Exclusion criteria: pregnancy, history of drug sensitivity, history of chronic pain syndromes and use of painkillers, alcohol and drug addiction.
Intervention groups
After the end of the surgery and before closing the wound in the first group, they will be nerve blocked by Erector Spina Plana Block method and the second group will be nerve blocked by TAP BLOCK method.
A comparative study of the analgesic effect of erector spina block and tap block in pain after open inguinal hernia surgery
Public title
A comparative study of the analgesic effect of erector spina block and tap block in pain after open inguinal hernia surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Those who were candidates for inguinal hernia repair surgery. Being between 20 and 65 years old.
Exclusion criteria:
Pregnancy, history of drug sensitivity, history of chronic pain syndromes and use of painkillers, alcohol and drug addiction.
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
28
Randomization (investigator's opinion)
Randomized
Randomization description
A lottery method will be used to assign patients to the first and second intervention groups. In the first stage, groups are written in the form of group A, B. Then a lottery is drawn between the two groups to determine which intervention group will be the first and which intervention group will be the second. In the second step, the numbers of two cards written on one A and the other B and completely closed and not visible are thrown into a container. Then, after obtaining consent from the patients and agreeing to participate in the study, they are asked to choose one of the two cards in the container in order to determine the intervention group. Then he takes a card from inside the container and hands it to the nurse. The nurse writes down the intervention group and the type of nerve block of the patient according to the group he belongs to, once before the start of the surgery and once again at the start of the nerve block (after the end surgery and before closing the wound) is informed to the attending physician and is performed according to the assigned group. Because the patients are not included in the study at the same time, until the sample size of both groups is completed, the patients will be included in the study one by one after referring for surgery, according to the inclusion criteria.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Patients will not be informed about the method and type of pain control nerve block. The physician evaluating pain and other variables will be unaware of each patient's group. The expert analyzing the data will be unaware of the intervention groups of the patients.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Qom Medical Sciences
Street address
Qom Medical Sciences Research Assistant Building Safashehr St. Qom
City
qom
Province
Ghoum
Postal code
3713649373
Approval date
2023-09-11, 1402/06/20
Ethics committee reference number
IR.MUQ.REC.1402.152
Health conditions studied
1
Description of health condition studied
inguinal hernia
ICD-10 code
K40.0
ICD-10 code description
Bilateral inguinal hernia, with obstruction, without gangrene
Primary outcomes
1
Description
pain relief
Timepoint
Immediately, 6, 12 and 24 hours after surgery
Method of measurement
Visual ruler of pain and also the amount of patients' request for painkiller injections
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Nerve block is done by the Erector Spina Plano Block method
Category
Treatment - Drugs
2
Description
Intervention group: They will be nervously blocked by the TAP BLOCK method