Clinical trial NCT04297046: Ultrasound-guided Two Different Type Blocks for Pain Relief in Totalabdominal Hysterectomy
Official title: Ultrasound-guided Transversus Abdominis Plane Block and Quadratus Lumborum Block as Preventive Analgesia in Total Abdominal Hysterectomy With Pfannenstiel Incision: a Prospective, Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ultrasonography
Keywords: Nerve block
analgesia
pain management
Lead sponsor: Bursa Yüksek İhtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2020-03-05
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Effective analgesia after total abdominal hysterectomy is important for faster recovery and preventing complications which depend to pain. A multimodal and preventive approach is preferred to ensure adequate analgesia and to avoid side effects due to high doses of analgesics. The hypothesis was that the Quadratus Lumborum block (application of local anesthetics to the side of the abdomen) would be superior to Transversus Abdominis Plane block (application of local anesthetics in front of the abdomen) for analgesia before abdominal incision in total abdominal hysterectomy. The primary goal of the study was to evaluate the feasibility of ultrasound-guided Transversus Abdominis Plane block and Quadratus Lumborum block. The secondary goal was to evaluate postoperative adverse effects and patient satisfaction.

Detailed description: The study protocol was approved by the Local Ethics Committee. Written informed consent was obtained from each patient. The study was carried out in accordance with The Code of Ethics of the Declaration of Helsinki. The study was conducted between April 2017 - July 2017 with a prospective, randomized, double-blind design on 62 patients who had undergone total abdominal hysterectomy with Pfannenstiel incision. American Society of Anesthesiologist (ASA) II-III, patients between the ages of 18-75 were included in the study. The participants with bleeding diathesis, those who could not communicate (mental disorder, language problem, etc.), those with allergies to the drugs used, those who did not wish to participate in the study, and those who had an infection in the block area were excluded from the study. The participants were divided into 2 groups with the sealed envelope technique preoperatively Transversus Abdominis Plane Block Procedure Before the surgical procedure, the muscles were screened at the umbilicus plain/mid-axillary line with the ultrasound using a linear probe while the participants in the supine position. The skin, subcutaneous adipose tissue, external oblique muscle, internal oblique muscle, transversus abdominis muscle, and peritoneum were visualized. The block needle was advanced in the posterolateral direction with the in-plain approach. 0.3 ml/kg of 0.25% bupivacaine was administered bilaterally into the space between the internal oblique muscle and the transversus abdominis muscle.

Transmuscular Quadratus Lumborum Block Procedure Quadratus lumborum muscle could be recognized with ultrasound via the convex probe was transversally attached above iliac crest at the midaxillary line while the patients were in the lateral decubitus position. The point of injection with a block needle in transmuscular Quadratus Lumborum Block is between the anterior border of Quadratus lumborum muscle and psoas major muscles. A transmuscular Quadratus Lumborum Block was performed bilaterally with 0,3 ml/kg 0.25% bupivacaine solution injection on each side.

Eligibility criteria: Inclusion Criteria:

* Undergone total abdominal hysterectomy with Pfannenstiel incision
* American Society of Anesthesiologist (ASA) I-III
* Patients between the ages of 18-65

Exclusion Criteria:

* Patients with bleeding diathesis
* Patients who could not communicate (mental disorder, language problem, etc.)
* Patients with allergies to the drugs used
* Patients who did not wish to participate in the study
* Patients who had an infection in the block area

Primary outcomes:
measure: iv PCA tramadol consumption
timeFrame: 24 hours
measure: intraoperatively fentanyl use
timeFrame: during operation
measure: The Visual analogue Scale (VAS)
timeFrame: 24 hours
Secondary outcomes:
measure: postoperative adverse effects
timeFrame: 24 hours
measure: patient and surgeon satisfaction: scores
timeFrame: 24 hours
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Bursa Yuksek Ihtisas Education and Research Hospital
Study officials:
affiliation: Medical Doctor of Anesthesiology Department
name: Canan Yilmaz
role: PRINCIPAL_INVESTIGATOR
References: