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

NCT04297046 | Completed

• 1 other identifier: 2017-7/9
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Ultrasonography

Keywords

Nerve block; analgesia; pain management

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• postoperative adverse effects

  24 hours

• patient and surgeon satisfaction: scores

  24 hours

Study Arms (2)

QLB for total abdominal hysterectomy

ACTIVE COMPARATOR

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)

TAPB for total abdominal hysterect0my

ACTIVE COMPARATOR

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)

Interventions

PCA (patient controlled analgesia) DEVICE

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.

QLB for total abdominal hysterectomy; TAPB for total abdominal hysterect0my

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bursa Yuksek Ihtisas Training and Research Hospital: lead

Study Sites (1)

Bursa Yuksek Ihtisas Education and Research Hospital

Bursa, 16310, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Agnosia

Interventions

Analgesia, Patient-Controlled

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia

Study Officials

• Canan Yilmaz

  Medical Doctor of Anesthesiology Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: After general anesthesia was given to the participant, the blocks were made. The participant did not know the type of block made to him.The outcomes assessor evaluating the participants after the surgery does not know the type of block made to the patients.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: February 28, 2020
• First Posted: March 5, 2020
• Study Start: April 1, 2017
• Primary Completion: July 30, 2017
• Study Completion: July 31, 2017
• Last Updated: October 27, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)