Transversalis Fascia Plane BlockNCT06847022
Efficacy of US-guided TFPB in Open Gynecologic Surgery
A study testing US-guided transversalis fascia plane block in people with Transversalis Fascia Plane Block and Gynecologic Surgical Procedures, run by Thammasat University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Transversalis Fascia Plane Block, Gynecologic Surgical Procedures
- What is being tested?
- US-guided transversalis fascia plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteThailand
- Study dates
- 4 Nov 2024to 30 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who undergoing open gynecologic surgery under general anesthesia
- Age 18 - 70 years
- ASA Physical status I-III
- Transverse incision
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of Anesthesiology, Faculty of Medicine, Thammasat University
Pathum Thani, 12121
About this study
Official title: Efficacy of Ultrasound-guided Transversalis Fascia Plane Block (TFPB) in Controlling Postoperative Pain After Transverse Incision in Gynecologic Surgery
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.
Read the detailed description
A randomized controlled trial study in which comparing US-guided TFPB vs conventional pain control in open gynecologic surgery
- Being tested
- US-guided transversalis fascia plane block
- Keywords
- Transversalis fascia plane block, open gynecologic surgery, transverse incision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
US-guided transversalis fascia plane blockProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: US-guided transversalis fascia plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative 24 hours morphine requirement
Measured: 24 hours
Secondary outcomes (3)
postoperative pain score
Measured: 1 hour, 6 hours, 24 hours
Side effects from postoperative opioids
nausea vomiting, itching, respiratory depression
Measured: 24 hours
Incidence of chronic pelvic pain
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start4 Nov 2024
- Primary completion30 May 2025
- Study completion30 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Transversalis Fascia Plane BlockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thammasat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PREEYAPHAN ARUNAKUL, Thammasat University
- Investigators
- Assist. Prof. Dr. Preeyaphan Arunakul, M.D., FRCAT, Principal investigator, Faculty of Medicine, Thammasat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06847022
- Sponsor's protocol ID
- MTU-EC-AN-1-062/67
- Status last verified
- May 2026
- First submitted
- 16 Feb 2025
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
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.
PubMed 25806905Chilkoti 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.
PubMed 36111099Black 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.
PubMed 30886131Fouad 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.
PubMed 33785672Geng 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.
PubMed 36635627Wilson 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.
PubMed 33779215VanDenKerkhof 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.
PubMed 22157741Ohnesorge 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.
PubMed 32500680Amberbir 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.
PubMed 37363541Hebbard 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.
PubMed 19495909Pinarbasi 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.
PubMed 39039833
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Ultrasound-guided Transversalis Fascia Plane Block (TFPB) in Controlling Postoperative Pain After Transverse Incision in Gynecologic Surgery
- ClinicalTrials.gov ID
- NCT06847022
- Acronym / sponsor ID
- MTU-EC-AN-1-062/67
- Keywords
- Transversalis fascia plane block, open gynecologic surgery, transverse incision
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Thammasat UniversityUniversity, hospital or other
- Study start
- 4 Nov 2024 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 Aug 2025 (actual)
- First posted
- 26 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
A randomized controlled trial study in which comparing US-guided TFPB vs conventional pain control in open gynecologic surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –Patients in control group will receive general anesthesia for open gynecologic surgery. |
| TFPB | Experimental | Procedure: US-guided transversalis fascia plane blockPatients in this study group will receive general anesthesia and US-guided bilateral TFPB after wound closure. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who undergoing open gynecologic surgery under general anesthesia
- Age 18 - 70 years
- ASA Physical status I-III
- Transverse incision
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| US-guided transversalis fascia plane blockUS-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. | Procedure or surgery | TFPB |
Primary outcome
Postoperative 24 hours morphine requirement
Time frame: 24 hours
3 secondary outcomes
postoperative pain score
Time frame: 1 hour, 6 hours, 24 hours
Side effects from postoperative opioids
Time frame: 24 hours
Incidence of chronic pelvic pain
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- BackgroundManagement 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: PubMed 25806905van 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.
- Background: PubMed 36111099Chilkoti 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.
- Background: PubMed 30886131Black 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.
- Background: PubMed 33785672Fouad 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.
- Background: PubMed 36635627Geng 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.
- Background: PubMed 33779215Wilson 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.
- Background: PubMed 22157741VanDenKerkhof 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.
- Background: PubMed 32500680Ohnesorge 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.
- Background: PubMed 37363541Amberbir 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.
- Background: PubMed 19495909Hebbard 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.
- Background: PubMed 39039833Pinarbasi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Assist. Prof. Dr. Preeyaphan Arunakul, M.D., FRCAT principal investigator
Faculty of Medicine, Thammasat University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing US-guided transversalis fascia plane block in people with Transversalis Fascia Plane Block and Gynecologic Surgical Procedures, run by Thammasat University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative 24 hours morphine requirement (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06847022, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.