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Patients who will undergo laparoscopic gallbladder surgery are expected to experience less postoperative pain and have less need for morphine-derived painkillers.
For this reason, a total of 128 patients were planned to be included in the study, including a group of patients who were eligible for gallbladder surgery with transverse abdominis plane block (TAPB), a group of patients with quadratus lumborum plane block (QLB) and a group of patients with intravenous painkillers (IVA).
Group QLB (Quadratus lumborum plane block): 20 ml of 0.25% bupivacaine will be used each time for plane block on both sides. Patients will be sedated with 1 mg midazolam and 50 mcg fentanyl intravenously in the preoperative preparation room in the operating room and 20 ml of 0.25% bupivacaine was administered bilaterally on each side under ultrasound guidance. After the block application, the patient was taken to the operating room and standard general anaesthesia was applied. Patients will not be given any analgesic medication before awakening from anaesthesia.
Group TAPB (Transverse abdominis plane block): 20 ml of 0.25% bupivacaine will be used each time for plane block on both sides. Patients will be sedated with 1 mg midazolam and 50 mcg fentanyl intravenously in the preoperative preparation room in the operating room and 20 ml of 0.25% bupivacaine was administered bilaterally on each side under ultrasound guidance. After the block application, the patient was taken to the operating room and standard general anaesthesia was applied. Patients will not be given any analgesic medication before awakening from anaesthesia.
For both Group QLB and Group TAPB block group;
Group IVA (Intravenous analgesia): These patients will be administered 1000 mg paracetamol intravenously in the preoperative waiting room in the operating room approximately 20-30 minutes before induction of anaesthesia. No block procedure will be performed. Patients will not be given any analgesic medication before awakening from anaesthesia.
Statistical methods / analysis: Power analysis (G-Power version 3.1.9.4 (University Kiel, Germany) program was used to calculate the sample size. The two-tailed alpha error was taken as 0.05, power as 0.80 and effect size as 0.8, and based on a previous study the allocation ratio was accepted as N2/N1:1. The minimum number of patients to be included in the study was calculated as 52.
SPSS 16.0 for Windows (SPSS Inc., Chicago, USA) was used for other statistical analyses. Statistical data were expressed as mean and standard deviation, while categorical data were expressed as frequency and percentage. Comparison of categorical data in the groups was done with Chi-square, the results were given as %n. Shapiro-Wilk tests were used to determine if the numerical data fit the normal distribution. While the data fitting the normal distribution were evaluated with the Student's t-test. Mann- Whitney U tests were used to compare the data differ from the normal distribution. p <0.05 was considered statistically significant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group QLB (quadratus lumborum plane block) | Group QLB (quadratus lumborum plane block): 20 ml of 0.25% bupivacaine will be used each time for plane block on both sides. Patients will be sedated with 1 mg midazolam and 50 mcg fentanyl intravenously in the preoperative preparation room in the operating room and 20 ml of 0.25% bupivacaine was administered bilaterally on each side under ultrasound guidance. After the block application, the patient was taken to the operating room and standard general anaesthesia was applied. - Plane block applications will be applied only once in the preoperative period |
| |
| Group TAPB (transverse abdominis plane block) | Group TAPB (transverse abdominis plane block): 20 ml of 0.25% bupivacaine will be used each time for plane block on both sides. Patients will be sedated with 1 mg midazolam and 50 mcg fentanyl intravenously in the preoperative preparation room in the operating room and 20 ml of 0.25% bupivacaine was administered bilaterally on each side under ultrasound guidance. After the block application, the patient was taken to the operating room and standard general anaesthesia was applied. |
| |
| Group IVA (Intravenous analgesia) | Group IVA (Intravenous analgesia): These patients will be administered 1000 mg paracetamol intravenously in the preoperative waiting room in the operating room approximately 20-30 minutes before induction of anaesthesia. No block procedure will be performed. Patients will not be given any analgesic medication before awakening from anaesthesia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quadratus lumborum plane block | Procedure | QLB (quadratus lumborum plane block): 20 ml of 0.25% bupivacaine will be used each time for plane block on both sides. Patients will be sedated with 1 mg midazolam and 50 mcg fentanyl intravenously in the preoperative preparation room in the operating room and 20 ml of 0.25% bupivacaine was administered bilaterally on each side under ultrasound guidance. After the block application, the patient was taken to the operating room and standard general anaesthesia was applied. |
| Measure | Description | Time Frame |
|---|---|---|
| VAS value of abdominal pain | The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." | 30 minutes, 2 hours, 4 hours, 12 hours, 24 hours after the patient is extubated |
| postoperative total tramadol consumption | Amount of tramadol used postoperatively (milligrams). If the VAS value of the patients is 4 and above, 100 mg tramadol is administered intravenously. | during the first 24 hours after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Sedation- agitation level | The Richmond Agitation Sedation Scale (RASS): identifies seven levels of sedation and agitation, which range from dangerous agitation to deep sedation, with a thorough description of patient behavior. The Richmond Agitation Sedation Scale (RASS) is a 10-point scale ranging from -5 to +4.Levels -1 to -5 denote 5 levels of sedation, starting with "awakens to voice" and ending with "unarousable." Levels +1 to +4 describe increasing levels of agitation. The lowest level of agitation starts with apprehension and anxiety, and peaks at combative and violent. RASS level 0 is "alert and calm. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who will undergo laparoscopic cholecystectomy surgery.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fatma Acil | Contact | +905337225225 | acilfatma@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Fatma Acil | Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital | Recruiting | Diyarbakır | 21070 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31649394 | Background | Verma K, Malawat A, Jethava D, Jethava DD. Comparison of transversus abdominis plane block and quadratus lumborum block for post-caesarean section analgesia: A randomised clinical trial. Indian J Anaesth. 2019 Oct;63(10):820-826. doi: 10.4103/ija.IJA_61_19. Epub 2019 Oct 10. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 11, 2024 | |
| Reset | Aug 15, 2024 | |
| Release | Dec 26, 2024 |
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| Transverse abdominis plane block | Procedure | TAPB (transverse abdominis plane block): 20 ml of 0.25% bupivacaine will be used each time for plane block on both sides. Patients will be sedated with 1 mg midazolam and 50 mcg fentanyl intravenously in the preoperative preparation room in the operating room and 20 ml of 0.25% bupivacaine was administered bilaterally on each side under ultrasound guidance. After the block application, the patient was taken to the operating room and standard general anaesthesia was applied. |
|
| Intravenous analgesia | Procedure | IVA (Intravenous analgesia): These patients will be administered 1000 mg paracetamol intravenously in the preoperative waiting room in the operating room approximately 20-30 minutes before induction of anaesthesia. No block procedure will be performed. Patients will not be given any analgesic medication before awakening from anaesthesia. |
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| during extubation |
| amount of fentanyl consumed during the operation | micrograms of fentanyl consumed during surgery | during surgery |
| nausea-vomiting | questioning about the presence/absence of nausea and/or vomiting in the postoperative period | 30 minutes, 2 hours, 4 hours, 12 hours, 24 hours after the patient is extubated |
| postoperative shoulder pain | shoulder pain patients will be asked to verbally assess whether there is pain or not | 30 minutes, 2 hours, 4 hours, 12 hours, 24 hours after the patient is extubated |
| surgical duration | Time in hours from the start of the surgical incision until the last surgical suture is placed | at the end of surgery |
| anaesthesia duration | time in hours from induction of anaesthesia to extubation | at the end of anaesthesia |
| length of hospital stay | days of hospitalisation after the operation | It is assessed for up to 12 months from the date of surgery to the date of the first documented progression or the date of death from any cause, whichever comes first |
| Reset | Jan 30, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 11, 2024 | Aug 15, 2024 | |||
| Dec 26, 2024 | Jan 30, 2025 |