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Status unknownNCT05780333Updated Mar 27, 2023

Effect of Different Plane Blocks on Quality of Recovery and Postoperative Pain After Laparoscopic Hysterectomy

An interventional study of TAP block and ESP block in Post Operative Pain, sponsored by Mentese State Hospital. Status unknown at 1 site in Turkey. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-03-27.

Sponsored by Mentese State Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2023), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
Female
01

Study summary

The goal of this clinical trial is to evaluate in effect of tap block and esp block on quality of recovery and postoperative pain after laparoscopic hysterectomy. The main question it aims to answer are: Are these two plane blocks used superior to each other? Participants;

  • will fill out the preoperative questionnaire
  • will fill out the postoperative questionnaire
  • will report their pain status according to the NRS score
Read the detailed description

Standard management of acute pain after surgery consists mainly of systemic opioid narcotics and nonsteroidal anti-inflammatory drugs (NSAIDs). Generally, opiates and NSAIDs are not completely effective at managing pain, and they carry significant risk of addiction and overdose, particularly with prolonged or increased dosing. The concept of multimodal or ''balanced'' analgesia is rapidly becoming the 'standard of care' for preventing post-operative pain. It consists of the use of combinations of analgesics of different classes with different sites of action in an attempt to provide superior pain relief with reduced analgesic related side effects. Local anesthetic injection to block specific nerves has been widely recognized as a useful adjunct in a multimodal approach to postoperative pain management.

Erector Spinae Plane (ESP) block is a recently described plane block designed to block the dorsal and ventral rami of the spinal nerves. And this block provides visceral and somatic pain block.

Transversus Abdominis plane (TAP) block involves the injection of LA between the transversus abdominis (TA) and internal oblique (IO) muscles.This interfascial plane contains the intercostal, subcostal, iliohypogastric, and ilioinguinal nerves. These nerves give sensation to the anterior and lateral abdominal wall as well as the parietal peritoneum, providing only somatic and not visceral analgesia.

02

Conditions studied

  • Post Operative Pain

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Keywords

  • tap block
  • esp block
  • postoperative pain
  • recovery
03

In context

Pain, Postoperative

5,089 studies on the registry are indexed under Pain, Postoperative; 1,137 are open to participants now.

This study's planned enrollment of 60 is below the median of 75 across 4,341 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Mentese State Hospital is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Female patients who will undergo hysterectomy under elective conditions
  • 18- 65 years
  • ASA I-II patients

Exclusion criteria

Exclusion Criteria:

  • Refusal during registration, request to be excluded from the study, failure to give informed consent
  • Under 18 years old and upper 65 years old
  • ASA III-IV patients
  • Chronic opioid use
  • Presence of infection at the injection site
  • Renal failure / Liver failure
  • Bupivacaine sensitivity
  • Use of anticoagulants
  • BMI \< 18,5 , BMI >35
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
60 participants (estimated)

Study arms

  • Other
    tap block

    Tap block is one of the frequently used field blocks for analgesia management of abdominal surgery. At the end of surgery and general anesthesia, transversus abdominis fascial plane will be detected with using lineer usg probe. With in-plane tecnique after placement of the needle in the transversus abdominis fascial plane, and careful aspiration to exclude vascular puncture, a test dose of 1 mL will be injected to determine resistance to flow, and confirm needle tip placement within the fascial plane. After this, 20 ml local anaestetic mixture will be injected through the needle. The TAP block will be then performed on the opposite side using an identical technique.

    Procedure: TAP block

  • Active comparator
    esp block

    The effectiveness of esp block is also evaluated in abdominal surgery after spinal surgery, thoracic and cardiovascular surgery. At the end of surgery and general anesthesia, in the lateral decubitus position, the linear probe will be placed approximately 3 cm lateral to the T10 spinous process, in the parasagittal plane. With the in-plane technique, when the block needle rests on the transverse process (approximately 3cm in depth), the erector spina plan will be confirmed with a 0.5-1 mL 0.9% NaCl test dose. 20 ml of local anesthetic mixture will be applied to the confirmed area. The procedure will be applied bilaterally.

    Procedure: ESP block

Interventions

  • ProcedureTAP block

    Bilateral tap block with 20 ml of mixture 2:1:1 (0.5% bupivacaine: 0.9%NaCl: 2% lidocain) for each

  • ProcedureESP block

    Bilateral esp block with 20 ml of mixture 2:1:1 (0.5% bupivacaine: 0.9%NaCl: 2% lidocain) for each

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What researchers measure

Primary outcomes

  1. Quality of Recovery 40 Questionnaire

    The global Quality of Recovery-40 aggregate score is a scale from (1 to 5, where: 1 = very poor and 5 = excellent)

    Time frame: 24 hours after surgery.

Secondary outcomes

  1. Postoperative pain

    is a numerical rating scale from (1 to 10, where: 1 is the mildest and 10 the worst possible)

    Time frame: 24 hours after surgery.

Other outcomes

  1. using salvage opiod

    Additional opioid use for nrs score of 4 and above

    Time frame: 24 hours after surgery.

07

Study locations

1 of 1 sites recruiting
  • Pelin Dilsiz Eker
    Muğla, Menteşe 48050, Turkey
    Recruiting
08

References and documents

Publications

  • Yap JY, Bhat M, McMullen W, Ragupathy K. Novel use of laparoscopic-guided TAP block in total laparoscopic hysterectomy. J Obstet Gynaecol. 2018 Jul;38(5):736. doi: 10.1080/01443615.2018.1444402. PubMed 29944049 ↗
  • Rosato C, Santonastaso DP, de Chiara A, Viola L, Russo E, Piccioni FG, Agnoletti V. Erector spinae plane block for pain management in laparoscopic hysterectomy and bilateral oophorectomy. J Clin Anesth. 2021 Jun;70:110184. doi: 10.1016/j.jclinane.2021.110184. Epub 2021 Feb 6. No abstract available. PubMed 33561705 ↗
  • Yagi K, Adachi K, Tanaka E, Toda A, Miyoshi Y, Funada R, Yamamoto Y. The Role of Preoperative and Postoperative Transversus Abdominis Plane and Rectus Sheath Block in Patients Undergoing Total Laparoscopic Hysterectomy. J Perianesth Nurs. 2020 Oct;35(5):491-495. doi: 10.1016/j.jopan.2020.02.014. Epub 2020 Jun 18. PubMed 32565029 ↗

Study documents

  • Informed consent form · Jan 21, 2023
  • Informed consent form · Jan 21, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05780333
Lead sponsor
Mentese State Hospital
Responsible party
Pelin Dilsiz Eker (MD., specialist, Mentese State Hospital) — Principal investigator
First posted
Mar 22, 2023
Start date
Jan 27, 2023
Primary completion
Jun 30, 2023 (estimated)
Completion
Jul 1, 2023 (estimated)
Last update
Mar 27, 2023

Study contacts

Pelin dilsiz eker, MD
Contact
pelin.dlsz@hotmail.com
05378401872
pelin dilsiz eker, MD
principal investigator · Mentese State Hospital
Ismail Gökbel, MD
study chair · Mentese State Hospital
Sinem Sari Ozturk, MD
study director · Aydin Adnan Menderes University, Department of anesthesiology and reanimation

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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