Efficacy of US-guided Transversalis Fascia Plane Block (TFPB) in Controlling Postoperative Pain After Open Gynecologic Surgery

NCT ID: NCT06847022

Last Updated: 2025-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-04

Study Completion Date

2025-08-30

Brief Summary

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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.

Detailed Description

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Conditions

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Transversalis Fascia Plane Block Gynecologic Surgical Procedures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

TFPB

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

Group Type EXPERIMENTAL

US-guided transversalis fascia plane block

Intervention Type PROCEDURE

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.

Interventions

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US-guided transversalis fascia plane block

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Thammasat University

OTHER

Sponsor Role lead

Responsible Party

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PREEYAPHAN ARUNAKUL

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, Thammasat University

Locations

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Department of Anesthesiology, Faculty of Medicine, Thammasat University

Pathum Thani, Changwat Pathum Thani, Thailand

Site Status

Countries

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Thailand

References

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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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 25806905 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36111099 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30886131 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33785672 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36635627 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33779215 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22157741 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32500680 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37363541 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19495909 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 39039833 (View on PubMed)

Other Identifiers

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MTU-EC-AN-1-062/67

Identifier Type: -

Identifier Source: org_study_id

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