Comparison of Quadratus Lumborum and Transverse Abdominis Plane Blocks With Intravenous Analgesic in Gallbladder Surgery

Cholecystectomy Clinical Trial

Official title:

Comparison of the Efficacy of Bilateral Transverse Abdominis Plane Block (TAPB) and Bilateral Quadratus Lumborum Block (QLB) With Intravenous Analgesic (IVA) Group for Preemptive Analgesia in Laparoscopic Cholecystectomy Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06058195
• Other study ID #: 03.03.2023/372
• Status: Recruiting
• Start date: October 3, 2023
• Est. completion date: February 16, 2024

Study information

• Verified date: January 2024
• Source: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
• Contact: Fatma Acil
• Phone: +905337225225
• Email: acilfatma[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

Description:

1. 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.

2. 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;

• Medical records will be audited to monitor adherence to the intervention.

• each patient will be administered 0.25% bupivacaine for each side (a total of 40 ml of 0.25% bupivacaine will be used)

• plane blocks will be applied under ultrasound guidance.

• plane block applications will be performed by anaesthesiologists with at least 5 years of experience

• Postoperative evaluations of patients will be performed face to face.

• Plane block applications will be applied only once in the preoperative period.

• In the postoperative period, 1000 mg paracetamol will be given intravenously if the pain intensity of the patients is below Visual Analogue Scale (VAS) 4. However, if the severity of pain is VAS 4 and above, 100 mg tramadol will be given intravenously.

• This study will be followed up in the general surgery unit.

• Patients will be monitored for pain and side effects at 30th minute, 2nd hour, 4th hour, 12th hour and 24th hour in the postoperative period.

• Both plane blocks are applied for analgesia in the postoperative period and aim to reduce opioid consumption in the postoperative period.

3. 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.

• Postoperative evaluations of patients will be performed face to face.

• Plane block applications will be applied only once in the preoperative period.

• In the postoperative period, 1000 mg paracetamol will be given intravenously if the pain intensity of the patients is below Visual Analogue Scale (VAS) 4. However, if the severity of pain is VAS 4 and above, 100 mg tramadol will be given intravenously.

• This study will be followed up in the general surgery unit.

• Patients will be monitored for pain and side effects at 30th minute, 2nd hour, 4th hour, 12th hour and 24th hour in the postoperative period.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: February 16, 2024
• Est. primary completion date: February 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Aged 18-70 years,

• who will undergo laparoscopic cholecystectomy and who meet the American Society of Anesthesiologists (ASA) I-III physical status

Exclusion Criteria:

• American Society of Anesthesiologists (ASA) physical status above 3

• Age < 18 or >70 years

• patient's reluctance

Related Conditions & MeSH terms

• Cholecystectomy

Intervention

Procedure:
• Quadratus lumborum plane block
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.
• Transverse abdominis plane block
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
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.

Locations

Country	Name	City	State
Turkey	Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital	Diyarbakir

Sponsors (1)

Lead Sponsor	Collaborator
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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.
Secondary	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.	during extubation
Secondary	amount of fentanyl consumed during the operation	micrograms of fentanyl consumed during surgery	during surgery
Secondary	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
Secondary	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
Secondary	surgical duration	Time in hours from the start of the surgical incision until the last surgical suture is placed	at the end of surgery
Secondary	anaesthesia duration	time in hours from induction of anaesthesia to extubation	at the end of anaesthesia
Secondary	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