The Influence of TAP Block in the Control of Postoperative Pain After Laparotomy for Gynecological Procedures

Summary

This study evaluates the influence of the transversus abdominis plane block on the intensity of postoperative pain and the concentration of proinflammatory and pain factors after hysterectomy by laparotomy. The patients will be randomized in three groups.In the first group, patients will receive intravenous, systemic, multimodal analgesia.In the second group there will be patients in who will be given the TAP block. The TAP block will be given postoperatively before waking. It will be given bilaterally in the before mentioned anatomic region (the so-called lateral TAP block). In the third group there will be patients who will be treated with TAP block in addition to systemic, mutimodal analgesia. The research will be based on completing a questionnaire (VAS scale and QoR questionnaire) and taking peripheral blood out. We expect that the concentration of proinflammatory and pain factors in patients treated with a TAP block will be lower and the quality of recovery will be better than that of patients receiving standard analgesic therapy (systemic multimodal analgesia).

Conditions

• Leiomyoma
• Pelvic Organ Prolapse
• Abnormal Uterine Bleeding
• Chronic Pain
• Premalignant Lesion
• Endometriosis

Interventions

DRUG

Systemic multimodal analgesia administered intravenously

Paracetamol 1 gram and ketoprofen 100 mg every 8 hours for 24 hours. Analgesia will start immediately after surgery. If the pain persists, the patient will be given "rescue" analgesia: tramadol 50 mg intravenously up to a maximum dose of 400 mg / 24 h and other analgesics if needed.

PROCEDURE

Transversus abdominis plane block (TAP block)

The TAP block will be given postoperatively before waking. It will be given bilaterally in the before mentioned anatomic region (the so-called lateral TAP block) of 0.25% levobupivacin in 40 ml bilaterally. If the pain persists, the patient will be given "rescue" analgesia: tramadol 50 mg intravenously up to a maximum dose of 400 mg / 24 h and other analgesics if needed.

OTHER

Combined transversus abdominis plane block (TAP block) with systemic multimodal analgesia administered intravenously

TAP block in addition to systemic, mutimodal analgesia. If such analgesia is not satisfactory, tramadol 50 mg intravenously, up to a maximum dose of 400 mg / 24h, and other analgesics will be given at the request of the patient.

Sponsors & Collaborators

• Clinical Hospital Center Rijeka

  collaborator OTHER

• General Hospital Pula

  lead OTHER

Principal Investigators

• Tomislav Perkov, MD · GH Pula

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-09-24

Primary Completion

2020-09-24

Completion

2021-12-31

Countries

• Croatia

Study Locations