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

NCT04172272 | Unknown DMC

• 1 other identifier: 3
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Transversus abdominis plane block; Laparotomy; Hysterectomy; Postoperative pain; Cytokines; Visual analogue scale; Quality of recovery

Outcome Measures

Primary Outcomes (3)

• The impact of three forms of postoperative analgesia (TAP block, systemic multimodal analgesia, combined TAP block and systemic multimodal analgesia)on postoperative pain after gynecological surgery

  Self-reported pain intensity using a standard visual analogue scale (VAS, from 0 to 10) in patients after gynecological surgery.

  48 hours

• Concentration of proinflammatory and pain factors in patients on postoperative pain after gynecological surgery

  Change in concentrations of individual cytokines (IL-1ß, IL-6) and hormones (catecholamines, cortisol) related to inflammation and pain

  Before surgery and 6, 24 and 48 hours after surgery

• Quality of recovery after gynecological surgery

  The impact of three forms of postoperative analgesia (TAP block, systemic multimodal analgesia and combined TAP block and systemic multimodal analgesia) on the quality of recovery in patients after gynecological surgery, measured by using a widely accepted 40-item Quality of Recovery (QoR) questionnaire

  30 days

Study Arms (3)

Systemic multimodal analgesia only

ACTIVE COMPARATOR

In the first group, patients will receive intravenous, systemic, multimodal analgesia: 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.

Drug: Systemic multimodal analgesia administered intravenously

TAP block only

EXPERIMENTAL

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) of 0.25% levobupivacaine in 40 ml bilaterally. 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.

Procedure: Transversus abdominis plane block (TAP block)

Combined TAP block with systemic multimodal analgesia

EXPERIMENTAL

In the third group there will be patients who will be treated with 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.

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

Interventions

Systemic multimodal analgesia administered intravenously DRUG

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.

Systemic multimodal analgesia only

Transversus abdominis plane block (TAP block) PROCEDURE

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.

TAP block only

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

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.

Combined TAP block with systemic multimodal analgesia

Eligibility Criteria

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

You may qualify if:

• Patients with a benign gynecological condition, who underwent hysterectomy by laparotomy approach.

You may not qualify if:

• under aged
• pregnant women,
• patients with malignant gynecological disease,
• those with anesthesiologic risk of ASA III or more,
• persons who are hypersensitive to anesthetics and analgesics,
• patients who do not agree with the study

Sponsors & Collaborators

• General Hospital Pula: lead
• Clinical Hospital Center Rijeka: collaborator

Study Sites (2)

GH Pula

Pula, 52100, Croatia

RECRUITING

Clinical centre Rijeka

Rijeka, 51000, Croatia

RECRUITING

Related Publications (8)

• Young MJ, Gorlin AW, Modest VE, Quraishi SA. Clinical implications of the transversus abdominis plane block in adults. Anesthesiol Res Pract. 2012;2012:731645. doi: 10.1155/2012/731645. Epub 2012 Jan 19.

  PMID: 22312327 BACKGROUND

• McDonnell JG, O'Donnell B, Curley G, Heffernan A, Power C, Laffey JG. The analgesic efficacy of transversus abdominis plane block after abdominal surgery: a prospective randomized controlled trial. Anesth Analg. 2007 Jan;104(1):193-7. doi: 10.1213/01.ane.0000250223.49963.0f.

  PMID: 17179269 BACKGROUND

• Abdallah FW, Chan VW, Brull R. Transversus abdominis plane block: a systematic review. Reg Anesth Pain Med. 2012 Mar-Apr;37(2):193-209. doi: 10.1097/AAP.0b013e3182429531.

  PMID: 22286518 BACKGROUND

• Yoshida T, Furutani K, Watanabe Y, Ohashi N, Baba H. Analgesic efficacy of bilateral continuous transversus abdominis plane blocks using an oblique subcostal approach in patients undergoing laparotomy for gynaecological cancer: a prospective, randomized, triple-blind, placebo-controlled study. Br J Anaesth. 2016 Dec;117(6):812-820. doi: 10.1093/bja/aew339.

  PMID: 27956680 BACKGROUND

• Dai C, Zhang K, Huang J. The Efficacy of Transversus Abdominis Plane Block for Abdominal Hysterectomy Post-operative Analgesia. Cureus. 2018 Aug 10;10(8):e3131. doi: 10.7759/cureus.3131.

  PMID: 30345190 BACKGROUND

• Easterday CL, Grimes DA, Riggs JA. Hysterectomy in the United States. Obstet Gynecol. 1983 Aug;62(2):203-12.

  PMID: 6408544 BACKGROUND

• American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2012 Feb;116(2):248-73. doi: 10.1097/ALN.0b013e31823c1030. No abstract available.

  PMID: 22227789 BACKGROUND

• Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008.

  PMID: 26827847 BACKGROUND

MeSH Terms

Conditions

Leiomyoma; Pelvic Organ Prolapse; Metrorrhagia; Chronic Pain; Endometriosis; Pain, Postoperative

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pain; Neurologic Manifestations; Signs and Symptoms; Postoperative Complications

Study Officials

• Tomislav Perkov, MD

  GH Pula

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dean Markić, MD, PHD, Prof.

CONTACT

+385915027956; dean.markic@medri.uniri.hr

Ivana Miletović, MD

CONTACT

385917818584; imiletovic@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 8, 2019
• First Posted: November 21, 2019
• Study Start: September 24, 2019
• Primary Completion: September 24, 2020
• Study Completion: December 31, 2021
• Last Updated: November 21, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

CR (2)