Ultrasound-guided Two Different Type Blocks for Pain Relief in Totalabdominal Hysterectomy

Ultrasound-guided Transversus Abdominis Plane Block and Quadratus Lumborum Block as Preventive Analgesia in Total Abdominal Hysterectomy With Pfannenstiel Incision: a Prospective, Randomized Trial

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.

Study Overview

• Status: Completed
• Conditions: Ultrasonography
• Intervention / Treatment: Device: PCA (patient controlled analgesia)

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Bursa, Turkey, 16310
    • Bursa Yüksek İhtisas Education and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: QLB for total abdominal hysterectomy; Quadratus lumborum block (QLB) was performed bilaterally with 0,3 ml/kg 0.25% bupivacaine (maximum dose 3 ml/kg) solution injection on each side.Combine patient-controlled intravenous analgesia(same as PCA for TAH arm).	Device: PCA (patient controlled analgesia); Intravenous Patient-Controlled Analgesia was used for postoperative pain control with a bolus dose of 25 mg Tramadol and a lockout interval of 20 min. The pain was evaluated at different times after the operation, both at rest and movement (Dynamic VAS) at the 0., 2., 6., 12. hours and 24h later. All patients received 1 g iv paracetamol 8 hourly intervals regularly. 75 mg im diclofenac sodium was given as rescue analgesic.
ACTIVE_COMPARATOR: TAPB for total abdominal hysterect0my; The transversus abdominis plane block (TAPB)was performed bilaterally with 0.3 ml/kg of 0.25% bupivacaine (maximum dose 3 ml/kg) solution . Combine patient-controlled intravenous analgesia(same as PCA for TAH arm).	Device: PCA (patient controlled analgesia); Intravenous Patient-Controlled Analgesia was used for postoperative pain control with a bolus dose of 25 mg Tramadol and a lockout interval of 20 min. The pain was evaluated at different times after the operation, both at rest and movement (Dynamic VAS) at the 0., 2., 6., 12. hours and 24h later. All patients received 1 g iv paracetamol 8 hourly intervals regularly. 75 mg im diclofenac sodium was given as rescue analgesic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
iv PCA tramadol consumption	tramadol consumption up to 24 hours	24 hours
intraoperatively fentanyl use	Total intraoperative fentanyl dose	during operation
The Visual analogue Scale (VAS)	The Visual Analogue Scale was used to measure the severity of postoperative pain (0= No pain, 10= The worst possible pain) up to 24 hours. Higher scores mean a worse outcome.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative adverse effects	nausea,vomiting, hypertension and hypotension incidences	24 hours
patient and surgeon satisfaction: scores	The patient and surgeon satisfaction score (0= Not satisfied, 4= Very satisfied) were recorded. Higher scores mean a better outcome.	24 hours

Collaborators and Investigators

• Sponsor: Bursa Yüksek İhtisas Education and Research Hospital
• Investigators: Principal Investigator: Canan Yilmaz, Medical Doctor of Anesthesiology Department

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2017
• Primary Completion (ACTUAL): July 30, 2017
• Study Completion (ACTUAL): July 31, 2017

Study Registration Dates

• First Submitted: February 28, 2020
• First Submitted That Met QC Criteria: March 4, 2020
• First Posted (ACTUAL): March 5, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 27, 2020
• Last Update Submitted That Met QC Criteria: October 25, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: analgesia; pain management; Nerve block
• Other Study ID Numbers: 2017-7/9

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No