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

NCT06058195 | Unknown

• 1 other identifier: 03.03.2023/372
• Study Type: observational
• Target: 128
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Cholecystectomy

Outcome Measures

Primary Outcomes (2)

• 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.

Secondary Outcomes (7)

• Sedation- agitation level

  during extubation

• amount of fentanyl consumed during the operation

  during surgery

• nausea-vomiting

  30 minutes, 2 hours, 4 hours, 12 hours, 24 hours after the patient is extubated

• postoperative shoulder pain

  30 minutes, 2 hours, 4 hours, 12 hours, 24 hours after the patient is extubated

• surgical duration

  at the end of surgery

Study Arms (3)

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

Procedure: Quadratus lumborum plane block

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.

Procedure: Transverse abdominis plane block

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.

Procedure: Intravenous analgesia

Interventions

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.

Group QLB (quadratus lumborum plane block)

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.

Group TAPB (transverse abdominis plane block)

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.

Group IVA (Intravenous analgesia)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who will undergo laparoscopic cholecystectomy surgery.

You may qualify if:

• Aged 18-70 years,
• who will undergo laparoscopic cholecystectomy and who meet the American Society of Anesthesiologists (ASA) I-III physical status

You may not qualify if:

• American Society of Anesthesiologists (ASA) physical status above 3
• Age \< 18 or \>70 years
• patient's reluctance

Sponsors & Collaborators

• Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital: lead

Study Sites (1)

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Diyarbakır, 21070, Turkey (Türkiye)

RECRUITING

Related 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.

  PMID: 31649394 BACKGROUND

Study Officials

• Fatma Acil

  Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fatma Acil

CONTACT

+905337225225; acilfatma@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 14, 2023
• First Posted: September 28, 2023
• Study Start: October 3, 2023
• Primary Completion: February 15, 2024
• Study Completion: February 16, 2024
• Last Updated: January 24, 2024

Record last verified: 2024-01

Locations

TU (1)