Analgesic Efficacy of Plan Blocks in Laparoscopic Hysterectomies

NCT05925972 | Completed

• 1 other identifier: DT/2022-04-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

Hysterectomy is the most common major intervention in gynecology after cesarean section. Indications include myoma uteri, abnormal uterine bleeding, cervical intraepithelial neoplasia, chronic pelvic pain, uterine uteri, operated breast cancer, and endometrial hyperplasia. Today, hysterectomy can be performed abdominally, vaginally and laparoscopically.¹ Laparoscopic hysterectomy (LH) has several advantages and disadvantages compared to other forms of hysterectomy. Shorter recovery time, less wound infection, shorter hospital stay, and less need for postoperative analgesia can be counted among the advantages. The prolongation of the operation time and the increased risk of urinary complications are disadvantages.² Postoperative pain management can be done with different methods depending on the location of the surgical field, the type of surgical procedure, the patient's need for analgesia, and patient preference. These methods include oral, intravenous or intramuscular medication and nerve blocks. In order to minimize the side effects of opioids used in analgesic therapy such as respiratory depression, nausea-vomiting, lethargy, constipation and itching, and to increase the analgesic effect, the "balanced analgesia" method is used.⁴ With this method, opioids, non-opioid analgesics or peripheral nerve-field blocks side effects are minimized and optimum analgesia is provided. Transversus abdominis plane (TAP) block, which is one of the abdominal field blocks, was first described by Rafi in 2001.⁶ Hebbard et al. stated in 2007 that ultrasonography (USG)-guided TAP block can be applied more effectively and safely.⁷ This block can be applied more effectively and safely.⁷ This block is antero-lateral, posterior, and oblique It can be done subcostal with three different approaches. TAP block has been shown to reduce postoperative pain after hysterectomy, cesarean section, and colorectal surgery.⁸ Erector spina plane (ESP) block was first described by Forero et al. in 2016 on a patient with chronic neuropathic pain.⁹ The basic technique is performed paraspinally under USG guidance. It is used for postoperative analgesia in breast, thoracic surgeries, hernia repair, dorsal colon, abdomen and hip surgery. In this study, it is aimed to compare the effects of USG-guided ESP block and OSTAP block applications on perioperative pain control in total laparoscopic hysterectomy operations.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• Plane blocks

  Analgesic efficacy between ESP and OSTAP blocks will be evaluated by Numeric Rating Scale. Intraoperative and postoperative opioid consumption will be compared.

  Intraoperative and postoperative first 24 hours

Secondary Outcomes (1)

• Nausea

  Intraoperative and postoperative first 24 hours

Study Arms (2)

Grup ESP

ACTIVE COMPARATOR

The group to which erector spina plane block will be applied

Procedure: Plane block

Grup OSTAP

ACTIVE COMPARATOR

The group to which oblique subcostal transversus abdominis plane block will be applied

Procedure: Plane block

Interventions

Plane block PROCEDURE

Plane block application in laparoscopic hysterectomies

Grup ESP; Grup OSTAP

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between 18-65 years laparoscopic hysterectomy under general anesthesia ASA I-II BMI ≤30 kg/m2

You may not qualify if:

• local anesthetic allergy coagulopathy infection at the block application site mental deficiency the surgical plan has been changed (complicated/open surgery)

Sponsors & Collaborators

• Balikesir University: lead

Study Sites (2)

Balikesir University

Balıkesir, 10145, Turkey (Türkiye)

Location

Medical faculty

Balıkesir, Turkey (Türkiye)

Location

Related Publications (2)

• Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.

  PMID: 27501016 RESULT

• 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 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Nazan Kocaoglu

  Balikesir University Medical Faculty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: June 29, 2023
• Study Start: March 6, 2023
• Primary Completion: August 15, 2024
• Study Completion: December 14, 2024
• Last Updated: February 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)