Optimal Peripheral Nerve Block After Minimally Invasive Colon Surgery

Surgery Clinical Trial

— OPMICS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04311099
• Other study ID #: OPMICS-1
• Status: Recruiting
• Phase: Phase 4
• Start date: January 14, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2023
• Source: Nordsjaellands Hospital
• Contact: Claus A Bertelsen, PhD
• Phone: +4551906303
• Email: cabertelsen[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: December 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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
• 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).

Related Conditions & MeSH terms

• Abdominal Pain
• Analgesia
• Colon Cancer
• Injection Site
• Pain, Abdominal
• Pain, Postoperative
• Surgery

Intervention

Drug:
• Active drug
Injection of Ropivacaine
• Placebo
Injection of Saline solution

Procedure:
• Injection of Ropivacaine - Ultrasound-guided transverse abdominal plane block
Lateral ultrasound-guided transverse abdominal plane block 40 ml ropivacaine 2 mg / ml
• Injection of Ropivacaine - Laparoscopic assisted transverse abdominal plane block
Laparoscopic assisted subcostal transverse abdominal plane block 40 ml ropivacaine 2 mg / ml
• Injection of placebo - Ultrasound-guided transverse abdominal plane block
Lateral ultrasound-guided transverse abdominal plane block with saline solution
• Injection of placebo - Laparoscopic assisted transverse abdominal plane block
Laparoscopic assisted subcostal transverse abdominal plane block with saline solution

Locations

Country	Name	City	State
Denmark	Sydvestjysk Sygehus	Esbjerg
Denmark	Regionshospitalet Herning	Herning
Denmark	Copenhagen University Hospital - North Zealand	Hillerød
Denmark	Copenhagen University Hospital - Hvidovre	Hvidovre
Denmark	Regionshospitalet Viborg	Viborg

Sponsors (1)

Lead Sponsor	Collaborator
Claus Anders Bertelsen, PhD, MD

Country where clinical trial is conducted

Denmark, 

References & Publications (22)

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. — View Citation

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. — View Citation

Chin KJ, McDonnell JG, Carvalho B, Sharkey A, Pawa A, Gadsden J. Essentials of Our Current Understanding: Abdominal Wall Blocks. Reg Anesth Pain Med. 2017 Mar/Apr;42(2):133-183. doi: 10.1097/AAP.0000000000000545. — View Citation

Dickerson DM, Apfelbaum JL. Local anesthetic systemic toxicity. Aesthet Surg J. 2014 Sep;34(7):1111-9. doi: 10.1177/1090820X14543102. Epub 2014 Jul 15. — View Citation

Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Ann Surg. 2017 Dec;266(6):e123. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Naidu RK, Richebe P. Probable local anesthetic systemic toxicity in a postpartum patient with acute Fatty liver of pregnancy after a transversus abdominis plane block. A A Case Rep. 2013 Dec 1;1(5):72-4. doi: 10.1097/ACC.0b013e3182973a2f. — View Citation

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. Erratum In: Reg Anesth Pain Med. 2010 May-Jun;35(2):325. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Statzer N, Cummings KC 3rd. Transversus Abdominis Plane Blocks. Adv Anesth. 2018 Dec;36(1):163-180. doi: 10.1016/j.aan.2018.07.007. Epub 2018 Sep 27. No abstract available. — View Citation

Sullivan MJL, Bishop SR, Pivik J. The pain catastrophizing scale: development and validation. Psychol Assess 1995; 7: 524.

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. — View Citation

Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x. — View Citation

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total morphine dose equivalents administered.	Intravenously in milligrams.	The first 24 hours from the end of anesthesia.
Secondary	Total morphine dose equivalents administered in the operation theater.	Intravenously in milligrams.	Up to 12 hours.
Secondary	Total morphine dose equivalents administered in the post anesthesia care unit.	Intravenously in milligrams.	The first 24 hours from the end of anesthesia.
Secondary	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).	Postoperative Day 1.
Secondary	Postoperative pain when coughing - 8:00-10:00 AM Postoperative Day 1	11-point Numeric Rating Scale. 0-10 (higher score means worse outcome)	Postoperative Day 1.
Secondary	Postoperative length of stay.	Days - Measured from the end of anesthesia.	Up to 30 days.
Secondary	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).	Postoperative Day 1.
Secondary	Total dose of antiemetic medication administered.	Intravenously in milligrams.	In the first 24 hours from the end of anesthesia.
Secondary	Total dose of antiemetic medication administered in the operating theater.	Intravenously in milligrams.	Up to 12 hours.
Secondary	Time spent in the post anesthesia care unit.	From the end of anesthesia to discharge to ward. Measured in hours and minutes.	Up to 30 hours.
Secondary	Postoperative mobilisation.	4-point Verbal Rating Scale. 1-4 (higher score means worse outcome).	Postoperative Day 1.
Secondary	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.	Postoperative Day 1.
Secondary	Postoperative complications.	According to the Clavien-Dindo classification of surgical complications.	Postoperative Day 30.
Secondary	Need for rescue TAP-block or epidural analgesia.	Epidural or TAP-block administered post surgery.	Postoperative Day 30.

External Links

•   Pausing or bridging patients in antithrombotic therapy, which should undergo an operative intervention.