Pain, PostoperativePhase 4OPMICSNCT04311099

Optimal Peripheral Nerve Block After Minimally Invasive Colon Surgery

A Phase 4 study testing Active drug, Injection of Ropivacaine - Ultrasound-guided transverse abdominal plane block and Injection of Ropivacaine - Laparoscopic assisted transverse abdominal plane block in people with Pain, Postoperative and Pain, Abdominal, run by Claus Anders Bertelsen, PhD, MD at 5 sites in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Pain, Postoperative, Pain, Abdominal, Analgesia
What is being tested?: Active drug, Injection of Ropivacaine - Ultrasound-guided transverse abdominal plane block and Injection of Ropivacaine - Laparoscopic assisted transverse abdominal plane block
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 360 participants
Where: 5 sitesDenmark
Study dates: 14 Jan 2021to 31 Mar 2024
Phase: Phase 4
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients planned to receive curative elective minimally invasive colon surgery for colon cancer or adenoma without a planned ostomy. Colon cancer or adenoma is defined by a distance of more than 15 cm from the anal verge to the distal limitation of the tumour or adenoma as measured by rigid sigmoidoscope. The following procedural codes are included:
Laparoscopic ileocecal resection
Laparoscopic right hemicolectomy
Other laparoscopic resection of both small and large bowel
Laparoscopic resection of transverse colon
Laparoscopic left hemicolectomy

Show all 9Show fewer

Laparoscopic resection of sigmoid colon
Other laparoscopic colon resection
Having given informed written consent.

Who cannot join

Known allergy to local analgesics
Known liver failure Class C according to the Child-Pugh Score
Body weight of less than 40 kg
History of being a chronic pain patient (weekly intake WHO step II or step III or adjuvant step I analgesic)
Presence of concomitant painful conditions other than low back pain that could confound the subject's trial assessments or self-evaluation of the index pain, e.g., syndromes with widespread pain such as fibromyalgia
Predictably non-compliant due to language barrier or psychiatric disease

Show all 13Show fewer

Patients rescheduled for open surgery, before the intervention has been administered
Patients where the indication for surgery changes before the intervention has been administered
Patients with known inflammatory bowel disease
Patients who have previously undergone open major abdominal surgery defined by prior intraabdominal surgery with a midline or upper abdominal incision of more than 8 cm
Incisional hernia
Patients with a history of abdominal wall surgery including resection of the external oblique muscles, the internal oblique muscles, the transversus abdominis muscles, the rectus abdominis muscles or their fascial components
Pregnancy (patients are screened using urine human chorionic gonadotropin upon admission if female and not postmenopausal).

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Denmark5 sites

Sydvestjysk Sygehus
Esbjerg, 6700
Regionshospitalet Herning
Herning, 7400
Copenhagen University Hospital - North Zealand
Hillerød, 3400
Copenhagen University Hospital - Hvidovre
Hvidovre, 2650
Regionshospitalet Viborg
Viborg, 8800

Other trials in Denmark

About this study

Official title: Laparoscopic vs Ultrasound-Guided Transversus Abdominis Plane Block in Minimally Invasive Colon Surgery: A Randomized Controlled Multicentre Clinical Trial

The purpose of the trial is to identify the "most simple non-inferior of three different methods", placebo, laparoscopic assisted transverse abdominal plane block (L-TAP) and ultrasound guided TAP block (US-TAP), using postoperative opioid consumption as a measure of efficacy in patients undergoing elective minimally invasive colon surgery in an ERAS setting. Postoperative pain scores and length of stay (LOS) will also be measured. The simplicity of the three methods is ranked as: 1) placebo, 2) L-TAP and 3) US-TAP.

Read the detailed description

Introducing laparoscopy in colorectal surgery and optimizing the postoperative care using the standardized protocols of enhanced recovery after surgery (ERAS) have significantly improved patient outcomes and LOS. Better pain management has the potential to further improve these outcomes. Since the introduction of ultrasound-guided abdominal wall blocks, much research has been done in that field, but no consensus has been reached concerning the optimal block technique; where to and when to inject the block, or which drug to use. Newly published randomized controlled trials show interesting results regarding the L-TAP which has several advantages to the US-TAP, including the ease of performance, less dependency on specialized skills or equipment and avoidance of intraperitoneal infiltration. but these results need to be solidified with multicentre trials. Besides optimizing postoperative pain management, better block techniques could potentially decrease LOS in patients after minimally invasive colorectal surgery.

Conditions: Pain, Postoperative, Pain, Abdominal, Analgesia, Surgery, Colon Cancer, Injection Site
Being tested: Active drug, Placebo, Injection of Ropivacaine - Ultrasound-guided transverse abdominal plane block, Injection of Ropivacaine - Laparoscopic assisted transverse abdominal plane block, Injection of placebo - Ultrasound-guided transverse abdominal plane block
Medical subject headings: Pain, Postoperative, Abdominal Pain, Agnosia, Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Active drugDrug
Also called Ropivacaine
Injection of Ropivacaine
PlaceboDrug
Also called Saline solution
Injection of Saline solution
Injection of Ropivacaine - Ultrasound-guided transverse abdominal plane blockProcedure or surgery
Lateral ultrasound-guided transverse abdominal plane block 40 ml ropivacaine 2 mg / ml
Injection of Ropivacaine - Laparoscopic assisted transverse abdominal plane blockProcedure or surgery
Laparoscopic assisted subcostal transverse abdominal plane block 40 ml ropivacaine 2 mg / ml
Injection of placebo - Ultrasound-guided transverse abdominal plane blockProcedure or surgery
Lateral ultrasound-guided transverse abdominal plane block with saline solution
Injection of placebo - Laparoscopic assisted transverse abdominal plane blockProcedure or surgery
Laparoscopic assisted subcostal transverse abdominal plane block with saline solution

Study groups in NCT04311099
Study group	Role	What they receive
Ultrasound-guided TAP	Experimental	Ultrasound-guided TAP with 20 ml ropivacaine 2 mg/ml solution bilaterally and laparoscopic assisted injection of 20 ml saline (placebo) bilaterally at the beginning of surgery Receives: Drug: Active drug; Drug: Placebo; Procedure: Injection of Ropivacaine - Ultrasound-guided transverse abdominal plane block; Procedure: Injection of placebo - Laparoscopic assisted transverse abdominal plane block
Laparoscopic assisted TAP	Experimental	Laparoscopic assisted TAP with 20 ml ropivacaine 2 mg/ml solution bilaterally and ultrasound-guided injection of 20 ml saline (placebo) bilaterally at the beginning of surgery Receives: Drug: Active drug; Drug: Placebo; Procedure: Injection of Ropivacaine - Laparoscopic assisted transverse abdominal plane block; Procedure: Injection of placebo - Ultrasound-guided transverse abdominal plane block
Placebo	Placebo comparator	Laparoscopic assisted injection of 20 ml saline (placebo) bilaterally and ultrasound-guided injection of 20 ml saline (placebo) bilaterally at the beginning of surgery Receives: Drug: Placebo; Procedure: Injection of placebo - Ultrasound-guided transverse abdominal plane block; Procedure: Injection of placebo - Laparoscopic assisted transverse abdominal plane block

What is being measured

The primary outcome is the main question the study is designed to answer.

Total morphine dose equivalents administered.
Intravenously in milligrams.
Measured: The first 24 hours from the end of anesthesia.

Secondary outcomes (13)

Total morphine dose equivalents administered in the operation theater.
Intravenously in milligrams.
Measured: Up to 12 hours.
Total morphine dose equivalents administered in the post anesthesia care unit.
Intravenously in milligrams.
Measured: The first 24 hours from the end of anesthesia.
Postoperative pain at rest - 8:00-10:00 AM (ante meridiem) Postoperative Day 1.
11-point Numeric Rating Scale. 0-10 (higher score - worse outcome).
Measured: Postoperative Day 1.
Postoperative pain when coughing - 8:00-10:00 AM Postoperative Day 1
11-point Numeric Rating Scale. 0-10 (higher score means worse outcome)
Measured: Postoperative Day 1.
Postoperative length of stay.
Days - Measured from the end of anesthesia.
Measured: Up to 30 days.
Incidence of Postoperative Nausea and Vomiting - 8:00-10:00 AM Postoperative Day 1.
4-point Numeric Rating Scale. 0-3 (higher score means worse outcome).
Measured: Postoperative Day 1.
Total dose of antiemetic medication administered.
Intravenously in milligrams.
Measured: In the first 24 hours from the end of anesthesia.
Total dose of antiemetic medication administered in the operating theater.
Intravenously in milligrams.
Measured: Up to 12 hours.
Time spent in the post anesthesia care unit.
From the end of anesthesia to discharge to ward. Measured in hours and minutes.
Measured: Up to 30 hours.
Postoperative mobilisation.
4-point Verbal Rating Scale. 1-4 (higher score means worse outcome).
Measured: Postoperative Day 1.
Quality of Recovery 15.
The Quality of Recovery 15 is a 15-item questionnaire that measures the patient's quality of recovery. Each item is answered on an 11-point Numerical Rating Scale. The score ranges from 0 to 150 with a higher score indicating a better quality of recovery. It measures in the domains of pain, physical comfort, physical independence, psychological support, and emotional state.
Measured: Postoperative Day 1.
Postoperative complications.
According to the Clavien-Dindo classification of surgical complications.
Measured: Postoperative Day 30.
Need for rescue TAP-block or epidural analgesia.
Epidural or TAP-block administered post surgery.
Measured: Postoperative Day 30.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Jan 202131 Mar 2024

First posted17 Mar 2020
Study start14 Jan 2021
Primary completion8 Feb 2024
Study completion31 Mar 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (25)Papers the sponsor has linked to this study.
Other trials for Pain, PostoperativeStudies 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 360 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04311099
Sponsor's protocol ID: OPMICS-1
Acronym: OPMICS
Status last verified: Aug 2025
First submitted: 9 Mar 2020
Last updated: 7 Aug 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: After de-identification, individual participant data will be made available to investigators who provide a methodologically sound proposal for meta-analyses. Proposals should be directed to Claus A Bertelsen (cabertelsen@gmail.com). A Data Processing Agreement according to the EU General Data Protection Regulation has to be signed before data sharing.

Publications

Helander EM, Webb MP, Bias M, Whang EE, Kaye AD, Urman RD. A Comparison of Multimodal Analgesic Approaches in Institutional Enhanced Recovery After Surgery Protocols for Colorectal Surgery: Pharmacological Agents. J Laparoendosc Adv Surg Tech A. 2017 Sep;27(9):903-908. doi: 10.1089/lap.2017.0338. Epub 2017 Jul 25.
PubMed 28742427
Grant MC, Yang D, Wu CL, Makary MA, Wick EC. Impact of Enhanced Recovery After Surgery and Fast Track Surgery Pathways on Healthcare-associated Infections: Results From a Systematic Review and Meta-analysis. Ann Surg. 2017 Jan;265(1):68-79. doi: 10.1097/SLA.0000000000001703.
PubMed 28009729
Johns N, O'Neill S, Ventham NT, Barron F, Brady RR, Daniel T. Clinical effectiveness of transversus abdominis plane (TAP) block in abdominal surgery: a systematic review and meta-analysis. Colorectal Dis. 2012 Oct;14(10):e635-42. doi: 10.1111/j.1463-1318.2012.03104.x.
PubMed 22632762
Neal JM, Brull R, Chan VW, Grant SA, Horn JL, Liu SS, McCartney CJ, Narouze SN, Perlas A, Salinas FV, Sites BD, Tsui BC. The ASRA evidence-based medicine assessment of ultrasound-guided regional anesthesia and pain medicine: Executive summary. Reg Anesth Pain Med. 2010 Mar-Apr;35(2 Suppl):S1-9. doi: 10.1097/AAP.0b013e3181d22fe0.
PubMed 20216019
Borglum J, Gogenur I, Bendtsen TF. Abdominal wall blocks in adults. Curr Opin Anaesthesiol. 2016 Oct;29(5):638-43. doi: 10.1097/ACO.0000000000000378.
PubMed 27429253
Keller DS, Madhoun N, Ponte-Moreno OI, Ibarra S, Haas EM. Transversus abdominis plane blocks: pilot of feasibility and the learning curve. J Surg Res. 2016 Jul;204(1):101-8. doi: 10.1016/j.jss.2016.04.012. Epub 2016 Apr 27.
PubMed 27451874
Keller DS, Ermlich BO, Schiltz N, Champagne BJ, Reynolds HL Jr, Stein SL, Delaney CP. The effect of transversus abdominis plane blocks on postoperative pain in laparoscopic colorectal surgery: a prospective, randomized, double-blind trial. Dis Colon Rectum. 2014 Nov;57(11):1290-7. doi: 10.1097/DCR.0000000000000211.
PubMed 25285696
Favuzza J, Brady K, Delaney CP. Transversus abdominis plane blocks and enhanced recovery pathways: making the 23-h hospital stay a realistic goal after laparoscopic colorectal surgery. Surg Endosc. 2013 Jul;27(7):2481-6. doi: 10.1007/s00464-012-2761-y. Epub 2013 Jan 26.
PubMed 23355160
Rafi AN. Abdominal field block: a new approach via the lumbar triangle. Anaesthesia. 2001 Oct;56(10):1024-6. doi: 10.1046/j.1365-2044.2001.02279-40.x. No abstract available.
PubMed 11576144
Hebbard P, Fujiwara Y, Shibata Y, Royse C. Ultrasound-guided transversus abdominis plane (TAP) block. Anaesth Intensive Care. 2007 Aug;35(4):616-7. No abstract available.
PubMed 18020088
Chetwood A, Agrawal S, Hrouda D, Doyle P. Laparoscopic assisted transversus abdominis plane block: a novel insertion technique during laparoscopic nephrectomy. Anaesthesia. 2011 Apr;66(4):317-8. doi: 10.1111/j.1365-2044.2011.06664.x. No abstract available.
PubMed 21401554
Elamin G, Waters PS, Hamid H, O'Keeffe HM, Waldron RM, Duggan M, Khan W, Barry MK, Khan IZ. Efficacy of a Laparoscopically Delivered Transversus Abdominis Plane Block Technique during Elective Laparoscopic Cholecystectomy: A Prospective, Double-Blind Randomized Trial. J Am Coll Surg. 2015 Aug;221(2):335-44. doi: 10.1016/j.jamcollsurg.2015.03.030. Epub 2015 Mar 27.
PubMed 25899736
Park SY, Park JS, Choi GS, Kim HJ, Moon S, Yeo J. Comparison of Analgesic Efficacy of Laparoscope-Assisted and Ultrasound-Guided Transversus Abdominis Plane Block after Laparoscopic Colorectal Operation: A Randomized, Single-Blind, Non-Inferiority Trial. J Am Coll Surg. 2017 Sep;225(3):403-410. doi: 10.1016/j.jamcollsurg.2017.05.017. Epub 2017 Jun 10.
PubMed 28610880
Zaghiyan KN, Mendelson BJ, Eng MR, Ovsepyan G, Mirocha JM, Fleshner P. Randomized Clinical Trial Comparing Laparoscopic Versus Ultrasound-Guided Transversus Abdominis Plane Block in Minimally Invasive Colorectal Surgery. Dis Colon Rectum. 2019 Feb;62(2):203-210. doi: 10.1097/DCR.0000000000001292.
PubMed 30540660
Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013 Jun;118(6):1332-40. doi: 10.1097/ALN.0b013e318289b84b.
PubMed 23411725

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Laparoscopic vs Ultrasound-Guided Transversus Abdominis Plane Block in Minimally Invasive Colon Surgery: A Randomized Controlled Multicentre Clinical Trial
ClinicalTrials.gov ID: NCT04311099
Acronym / sponsor ID: OPMICS / OPMICS-1
Conditions: Pain, Postoperative, Pain, Abdominal, Analgesia, Surgery, Colon Cancer, Injection Site
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 360 participants (actual)
Lead sponsor: Claus Anders Bertelsen, PhD, MDUniversity, hospital or other
Study start: 14 Jan 2021 (actual)
Primary completion: 8 Feb 2024 (actual)
Study completion: 31 Mar 2024 (actual)
First posted: 17 Mar 2020 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Ultrasound-guided TAP	Experimental	Drug: Active drug, Drug: Placebo, Procedure: Injection of Ropivacaine - Ultrasound-guided transverse abdominal plane block, Procedure: Injection of placebo - Laparoscopic assisted transverse abdominal plane blockUltrasound-guided TAP with 20 ml ropivacaine 2 mg/ml solution bilaterally and laparoscopic assisted injection of 20 ml saline (placebo) bilaterally at the beginning of surgery
Laparoscopic assisted TAP	Experimental	Drug: Active drug, Drug: Placebo, Procedure: Injection of Ropivacaine - Laparoscopic assisted transverse abdominal plane block, Procedure: Injection of placebo - Ultrasound-guided transverse abdominal plane blockLaparoscopic assisted TAP with 20 ml ropivacaine 2 mg/ml solution bilaterally and ultrasound-guided injection of 20 ml saline (placebo) bilaterally at the beginning of surgery
Placebo	Placebo comparator	Drug: Placebo, Procedure: Injection of placebo - Ultrasound-guided transverse abdominal plane block, Procedure: Injection of placebo - Laparoscopic assisted transverse abdominal plane blockLaparoscopic assisted injection of 20 ml saline (placebo) bilaterally and ultrasound-guided injection of 20 ml saline (placebo) bilaterally at the beginning of surgery

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Patients planned to receive curative elective minimally invasive colon surgery for colon cancer or adenoma without a planned ostomy. Colon cancer or adenoma is defined by a distance of more than 15 cm from the anal verge to the distal limitation of the tumour or adenoma as measured by rigid sigmoidoscope. The following procedural codes are included:
Laparoscopic ileocecal resection
Laparoscopic right hemicolectomy
Other laparoscopic resection of both small and large bowel
Laparoscopic resection of transverse colon

Key exclusion criteria (13 listed)

Known allergy to local analgesics
Known liver failure Class C according to the Child-Pugh Score
Body weight of less than 40 kg
History of being a chronic pain patient (weekly intake WHO step II or step III or adjuvant step I analgesic)
Presence of concomitant painful conditions other than low back pain that could confound the subject's trial assessments or self-evaluation of the index pain, e.g., syndromes with widespread pain such as fibromyalgia

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
Active drugAlso: RopivacaineInjection of Ropivacaine	Drug	Laparoscopic assisted TAP, Ultrasound-guided TAP
PlaceboAlso: Saline solutionInjection of Saline solution	Drug	Laparoscopic assisted TAP, Placebo, Ultrasound-guided TAP
Injection of Ropivacaine - Ultrasound-guided transverse abdominal plane blockLateral ultrasound-guided transverse abdominal plane block 40 ml ropivacaine 2 mg / ml	Procedure or surgery	Ultrasound-guided TAP
Injection of Ropivacaine - Laparoscopic assisted transverse abdominal plane blockLaparoscopic assisted subcostal transverse abdominal plane block 40 ml ropivacaine 2 mg / ml	Procedure or surgery	Laparoscopic assisted TAP
Injection of placebo - Ultrasound-guided transverse abdominal plane blockLateral ultrasound-guided transverse abdominal plane block with saline solution	Procedure or surgery	Laparoscopic assisted TAP, Placebo
Injection of placebo - Laparoscopic assisted transverse abdominal plane blockLaparoscopic assisted subcostal transverse abdominal plane block with saline solution	Procedure or surgery	Placebo, Ultrasound-guided TAP

Primary outcome

Total morphine dose equivalents administered.
Time frame: The first 24 hours from the end of anesthesia.
Intravenously in milligrams.

13 secondary outcomes

Total morphine dose equivalents administered in the operation theater.
Time frame: Up to 12 hours.
Total morphine dose equivalents administered in the post anesthesia care unit.
Time frame: The first 24 hours from the end of anesthesia.
Postoperative pain at rest - 8:00-10:00 AM (ante meridiem) Postoperative Day 1.
Time frame: Postoperative Day 1.
Postoperative pain when coughing - 8:00-10:00 AM Postoperative Day 1
Time frame: Postoperative Day 1.
Postoperative length of stay.
Time frame: Up to 30 days.
Incidence of Postoperative Nausea and Vomiting - 8:00-10:00 AM Postoperative Day 1.
Time frame: Postoperative Day 1.
Total dose of antiemetic medication administered.
Time frame: In the first 24 hours from the end of anesthesia.
Total dose of antiemetic medication administered in the operating theater.
Time frame: Up to 12 hours.
Time spent in the post anesthesia care unit.
Time frame: Up to 30 hours.
Postoperative mobilisation.
Time frame: Postoperative Day 1.
Quality of Recovery 15.
Time frame: Postoperative Day 1.
Postoperative complications.
Time frame: Postoperative Day 30.
Need for rescue TAP-block or epidural analgesia.
Time frame: Postoperative Day 30.

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 7 Aug 2025.
Background: PubMed 28742427Helander EM, Webb MP, Bias M, Whang EE, Kaye AD, Urman RD. A Comparison of Multimodal Analgesic Approaches in Institutional Enhanced Recovery After Surgery Protocols for Colorectal Surgery: Pharmacological Agents. J Laparoendosc Adv Surg Tech A. 2017 Sep;27(9):903-908. doi: 10.1089/lap.2017.0338. Epub 2017 Jul 25.
Background: PubMed 28009729Grant MC, Yang D, Wu CL, Makary MA, Wick EC. Impact of Enhanced Recovery After Surgery and Fast Track Surgery Pathways on Healthcare-associated Infections: Results From a Systematic Review and Meta-analysis. Ann Surg. 2017 Jan;265(1):68-79. doi: 10.1097/SLA.0000000000001703.
Background: PubMed 22632762Johns N, O'Neill S, Ventham NT, Barron F, Brady RR, Daniel T. Clinical effectiveness of transversus abdominis plane (TAP) block in abdominal surgery: a systematic review and meta-analysis. Colorectal Dis. 2012 Oct;14(10):e635-42. doi: 10.1111/j.1463-1318.2012.03104.x.
Background: PubMed 20216019Neal JM, Brull R, Chan VW, Grant SA, Horn JL, Liu SS, McCartney CJ, Narouze SN, Perlas A, Salinas FV, Sites BD, Tsui BC. The ASRA evidence-based medicine assessment of ultrasound-guided regional anesthesia and pain medicine: Executive summary. Reg Anesth Pain Med. 2010 Mar-Apr;35(2 Suppl):S1-9. doi: 10.1097/AAP.0b013e3181d22fe0.
Background: PubMed 27429253Borglum J, Gogenur I, Bendtsen TF. Abdominal wall blocks in adults. Curr Opin Anaesthesiol. 2016 Oct;29(5):638-43. doi: 10.1097/ACO.0000000000000378.
Background: PubMed 27451874Keller DS, Madhoun N, Ponte-Moreno OI, Ibarra S, Haas EM. Transversus abdominis plane blocks: pilot of feasibility and the learning curve. J Surg Res. 2016 Jul;204(1):101-8. doi: 10.1016/j.jss.2016.04.012. Epub 2016 Apr 27.
Background: PubMed 25285696Keller DS, Ermlich BO, Schiltz N, Champagne BJ, Reynolds HL Jr, Stein SL, Delaney CP. The effect of transversus abdominis plane blocks on postoperative pain in laparoscopic colorectal surgery: a prospective, randomized, double-blind trial. Dis Colon Rectum. 2014 Nov;57(11):1290-7. doi: 10.1097/DCR.0000000000000211.
Background: PubMed 23355160Favuzza J, Brady K, Delaney CP. Transversus abdominis plane blocks and enhanced recovery pathways: making the 23-h hospital stay a realistic goal after laparoscopic colorectal surgery. Surg Endosc. 2013 Jul;27(7):2481-6. doi: 10.1007/s00464-012-2761-y. Epub 2013 Jan 26.
Background: PubMed 11576144Rafi AN. Abdominal field block: a new approach via the lumbar triangle. Anaesthesia. 2001 Oct;56(10):1024-6. doi: 10.1046/j.1365-2044.2001.02279-40.x. No abstract available.
Background: PubMed 18020088Hebbard P, Fujiwara Y, Shibata Y, Royse C. Ultrasound-guided transversus abdominis plane (TAP) block. Anaesth Intensive Care. 2007 Aug;35(4):616-7. No abstract available.
Background: PubMed 21401554Chetwood A, Agrawal S, Hrouda D, Doyle P. Laparoscopic assisted transversus abdominis plane block: a novel insertion technique during laparoscopic nephrectomy. Anaesthesia. 2011 Apr;66(4):317-8. doi: 10.1111/j.1365-2044.2011.06664.x. No abstract available.
Background: PubMed 25899736Elamin G, Waters PS, Hamid H, O'Keeffe HM, Waldron RM, Duggan M, Khan W, Barry MK, Khan IZ. Efficacy of a Laparoscopically Delivered Transversus Abdominis Plane Block Technique during Elective Laparoscopic Cholecystectomy: A Prospective, Double-Blind Randomized Trial. J Am Coll Surg. 2015 Aug;221(2):335-44. doi: 10.1016/j.jamcollsurg.2015.03.030. Epub 2015 Mar 27.
Individual participant dataSharing planned: Yes. After de-identification, individual participant data will be made available to investigators who provide a methodologically sound proposal for meta-analyses. Proposals should be directed to Claus A Bertelsen (cabertelsen@gmail.com). A Data Processing Agreement according to the EU General Data Protection Regulation has to be signed before data sharing.

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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.

Claus A Bertelsen, PhD study chair

Copenhagen University Hospital - North Zealand

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 9 inclusion and 13 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 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Denmark. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Total morphine dose equivalents administered. (time frame: The first 24 hours from the end of anesthesia.). 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 NCT04311099, which also lists 25 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 7 Aug 2025.