NCT06847022

Brief Summary

Transversalis fascia plane block (TFPB) has been studied and has shown to be very effective in controlling postoperative pain after caesarean section but has not been studied in open gynecologic surgery with transverse incision. Inadequate pain control after open gynecologic surgery is associated with negative consequences such as chronic pelvic pain. The investigators aimed to evaluate the efficacy of TFPB in controlling postoperative pain after open gynecologic surgery with transverse incision.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 4, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 26, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2025

Completed
Last Updated

February 25, 2026

Status Verified

February 1, 2026

Enrollment Period

7 months

First QC Date

February 16, 2025

Last Update Submit

February 23, 2026

Conditions

Transversalis Fascia Plane BlockGynecologic Surgical Procedures

Keywords

Transversalis fascia plane blockopen gynecologic surgerytransverse incision

Outcome Measures

Primary Outcomes (1)

  • Postoperative 24 hours morphine requirement

    24 hours

Secondary Outcomes (3)

  • postoperative pain score

    1 hour, 6 hours, 24 hours

  • Side effects from postoperative opioids

    24 hours

  • Incidence of chronic pelvic pain

    3 months

Study Arms (2)

control

NO INTERVENTION

Patients in control group will receive general anesthesia for open gynecologic surgery.

TFPB

EXPERIMENTAL

Patients in this study group will receive general anesthesia and US-guided bilateral TFPB after wound closure.

Procedure: US-guided transversalis fascia plane block

Interventions

US-guided transversalis fascia plane blockPROCEDURE

US-guided bilateral transversalis fascia plane block, using Sonotap 110 mm and 0.25% bupivacaine 20 ml on each side, will be done after wound closure.

TFPB

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThis study aims to evaluate pain after open gynecologic surgery, so only female are eligible.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who undergoing open gynecologic surgery under general anesthesia
  • Age 18 - 70 years
  • ASA Physical status I-III
  • Transverse incision

You may not qualify if:

  • Creatinine clearance is less than 30 ml/min
  • Body weight \< 50 kg
  • Re-open surgery
  • Persistent chronic pelvic pain
  • Allergic to medications used in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology, Faculty of Medicine, Thammasat University

Pathum Thani, 12121, Thailand

Location

Related Publications (12)

  • Management of Chronic Pelvic Pain. In: Hibner M, editor. Management of Chronic Pelvic Pain: A Practical Manual. Cambridge: Cambridge University Press; 2021. p. i-ii.

    BACKGROUND

  • van Rijckevorsel DC, de Vries M, Schreuder LT, Wilder-Smith OH, van Goor H. Risk factors for chronic postsurgical abdominal and pelvic pain. Pain Manag. 2015;5(2):107-16. doi: 10.2217/pmt.14.47.

    PMID: 25806905BACKGROUND

  • Chilkoti GT, Gaur D, Saxena AK, Gupta A, Agarwal R, Jain S. Ultrasound-guided transversalis fascia plane block versus wound infiltration for both acute and chronic post-caesarean pain management - A randomised controlled trial. Indian J Anaesth. 2022 Jul;66(7):517-522. doi: 10.4103/ija.ija_173_22. Epub 2022 Jul 22.

    PMID: 36111099BACKGROUND

  • Black ND, Malhas L, Jin R, Bhatia A, Chan VWS, Chin KJ. The analgesic efficacy of the transversalis fascia plane block in iliac crest bone graft harvesting: a randomized controlled trial. Korean J Anesthesiol. 2019 Aug;72(4):336-343. doi: 10.4097/kja.d.18.00352. Epub 2019 Mar 19.

    PMID: 30886131BACKGROUND

  • Fouad AZ, Abdel-Aal IRM, Gadelrab MRMA, Mohammed HMES. Ultrasound-guided transversalis fascia plane block versus transmuscular quadratus lumborum block for post-operative analgesia in inguinal hernia repair. Korean J Pain. 2021 Apr 1;34(2):201-209. doi: 10.3344/kjp.2021.34.2.201.

    PMID: 33785672BACKGROUND

  • Geng ZY, Zhang Y, Bi H, Zhang D, Li Z, Jiang L, Song LL, Li XY. Addition of preoperative transversus abdominis plane block to multimodal analgesia in open gynecological surgery: a randomized controlled trial. BMC Anesthesiol. 2023 Jan 12;23(1):21. doi: 10.1186/s12871-023-01981-w.

    PMID: 36635627BACKGROUND

  • Wilson SH, Hellman KM, James D, Adler AC, Chandrakantan A. Mechanisms, diagnosis, prevention and management of perioperative opioid-induced hyperalgesia. Pain Manag. 2021 Apr;11(4):405-417. doi: 10.2217/pmt-2020-0105. Epub 2021 Mar 29.

    PMID: 33779215BACKGROUND

  • VanDenKerkhof EG, Hopman WM, Goldstein DH, Wilson RA, Towheed TE, Lam M, Harrison MB, Reitsma ML, Johnston SL, Medd JD, Gilron I. Impact of perioperative pain intensity, pain qualities, and opioid use on chronic pain after surgery: a prospective cohort study. Reg Anesth Pain Med. 2012 Jan-Feb;37(1):19-27. doi: 10.1097/AAP.0b013e318237516e.

    PMID: 22157741BACKGROUND

  • Ohnesorge H, Gunther V, Grunewald M, Maass N, Alkatout I. Postoperative pain management in obstetrics and gynecology. J Turk Ger Gynecol Assoc. 2020 Dec 4;21(4):287-297. doi: 10.4274/jtgga.galenos.2020.2020.0024. Epub 2020 Jun 5.

    PMID: 32500680BACKGROUND

  • Amberbir WD, Bayable SD, Fetene MB. The prevalence and factors associated with acute postoperative pain in elective gynecologic surgical patients at two referral hospitals in Addis Abeba, Ethiopia, 2021: a cross-sectional study. Ann Med Surg (Lond). 2023 Apr 27;85(6):2506-2511. doi: 10.1097/MS9.0000000000000716. eCollection 2023 Jun.

    PMID: 37363541BACKGROUND

  • Hebbard PD. Transversalis fascia plane block, a novel ultrasound-guided abdominal wall nerve block. Can J Anaesth. 2009 Aug;56(8):618-20. doi: 10.1007/s12630-009-9110-1. Epub 2009 Jun 4. No abstract available.

    PMID: 19495909BACKGROUND

  • Pinarbasi A, Altiparmak B, Korkmaz Toker M, Pirincci F, Ugur B. Ultrasound-guided transversalis fascia plane block or transversus abdominis plane block for recovery after caesarean section: A randomised clinical trial. Eur J Anaesthesiol. 2024 Oct 1;41(10):769-778. doi: 10.1097/EJA.0000000000002041. Epub 2024 Jul 22.

    PMID: 39039833BACKGROUND

Study Officials

  • Assist. Prof. Dr. Preeyaphan Arunakul, M.D., FRCAT

    Faculty of Medicine, Thammasat University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 16, 2025

First Posted

February 26, 2025

Study Start

November 4, 2024

Primary Completion

May 30, 2025

Study Completion

August 30, 2025

Last Updated

February 25, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)