TAP Block Efficacy After Lumbar Spine Surgery Through Anterior Approach: a Randomized, Placebo-controlled Study

Pain, Postoperative Clinical Trial

— TAP-LIF  

Official title:

Analgesic Efficacy of Transversus Abdominis Plane (TAP) Block After Lumbar Spine Surgery Through Anterior Approach (Anterior Lumbar or Direct Lateral Interbody Fusion): a Prospective, Randomized, Double-blind Placebo-controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02778178
• Other study ID #: 2014-52
• Secondary ID: 2015-002143-34
• Status: Completed
• Phase: Phase 4
• First received: May 18, 2016
• Last updated: May 18, 2017
• Start date: May 2, 2016
• Est. completion date: April 2017

Study information

• Verified date: May 2017
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Anterior Lumbar Interbody Fusion (ALIF) as well as Direct Lateral Interbody Fusion (DLIF) are established techniques for lumbar interbody fusion. In contrast with posterior approaches, they allow free approach to the anterior disc space without opening of the spinal canal or the neural foramina. However, the additional anterior approach conveys specific concerns, including abdominal pain that may delay recovery after surgery. The transversus abdominis plane (TAP) block is a validated approach for postoperative pain relief following abdominal surgeries. There is currently no evidence of the possible benefits of TAP block as part of multimodal pain management after ALIF/DLIF surgery. The investigator hypothesize that a single-injection TAP block reduces opioid consumption after anterior lumbar fusion surgery. The main goal of this prospective, randomized, double-blind, placebo-controlled study is to demonstrate a >35% reduction in opioid consumption during the 24h following ALIF/DLIF surgery.

Description:

Clinical trial : therapeutic, prospective, randomized,double blind, placebo-controlled, with parallel group, of superiority, in intention to treat, monocentric study.

The main steps of the study are:

• preoperative assessment of eligibility

• exclusion and inclusion criteria, written informed consent, baseline preoperative assessment (see specific section)

• randomization (using a computer generated list) immediately before induction of anesthesia

• TAP block: ropivacaine + clonidine (experimental group, n=20) OR saline (control group; n=20)

• anesthesia (propofol, sufentanil, cisatracurium, ketamine and desflurane) and postoperative analgesia (paracetamol, ketoprofen, nefopam, and patient-controlled analgesia with morphine) similar in both groups

• surgical procedure

• primary outcome parameter (morphine consumption first 24 hours; see specific section)

• secondary endpoints (see specific section, up to 6 months following surgery)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Man or woman over the age of 18 yr

• Patients with insurance coverage

• Patients able to provide free and informed consent

• Patients undergoing surgery by the ALIF or DLIF approaches

Exclusion Criteria:

• Patients receiving opioids as chronic treatment

• Patients with contra-indication to regional anesthesia or TAP block

• Patients unable to consent

• Patient refusal

• Patients with contra-indication to any drug included in the anesthesia or analgesia protocol

• Pregnancy or breast-feeding women

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• ropivacaine plus clonidine
20 mL ropivacaine 3.75 mg/ml + 75 µg clonidine, per side
• Placebo
20 mL saline 0.9%, per side

Device:
• ultrasound

Locations

Country	Name	City	State
France	Hôpital Roger Salengro, CHU de Lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

References & Publications (12)

Belavy D, Cowlishaw PJ, Howes M, Phillips F. Ultrasound-guided transversus abdominis plane block for analgesia after Caesarean delivery. Br J Anaesth. 2009 Nov;103(5):726-30. doi: 10.1093/bja/aep235. Epub 2009 Aug 22. — View Citation

Carney J, McDonnell JG, Ochana A, Bhinder R, Laffey JG. The transversus abdominis plane block provides effective postoperative analgesia in patients undergoing total abdominal hysterectomy. Anesth Analg. 2008 Dec;107(6):2056-60. doi: 10.1213/ane.0b013e3181871313. — View Citation

Comité douleur-anesthésie locorégionale et le comité des référentiels de la Sfar.. [Formalized recommendations of experts 2008. Management of postoperative pain in adults and children]. Ann Fr Anesth Reanim. 2008 Dec;27(12):1035-41. doi: 10.1016/j.annfar.2008.10.002. Epub 2008 Nov 21. French. — View Citation

El-Dawlatly AA, Turkistani A, Kettner SC, Machata AM, Delvi MB, Thallaj A, Kapral S, Marhofer P. Ultrasound-guided transversus abdominis plane block: description of a new technique and comparison with conventional systemic analgesia during laparoscopic cholecystectomy. Br J Anaesth. 2009 Jun;102(6):763-7. doi: 10.1093/bja/aep067. Epub 2009 Apr 17. Erratum in: Br J Anaesth. 2009 Oct;103(4):622. — View Citation

Farooq M, Carey M. A case of liver trauma with a blunt regional anesthesia needle while performing transversus abdominis plane block. Reg Anesth Pain Med. 2008 May-Jun;33(3):274-5. doi: 10.1016/j.rapm.2007.11.009. — View Citation

McDonnell JG, Curley G, Carney J, Benton A, Costello J, Maharaj CH, Laffey JG. The analgesic efficacy of transversus abdominis plane block after cesarean delivery: a randomized controlled trial. Anesth Analg. 2008 Jan;106(1):186-91, table of contents. doi: 10.1213/01.ane.0000290294.64090.f3. — View Citation

McDonnell JG, O'Donnell B, Curley G, Heffernan A, Power C, Laffey JG. The analgesic efficacy of transversus abdominis plane block after abdominal surgery: a prospective randomized controlled trial. Anesth Analg. 2007 Jan;104(1):193-7. Erratum in: Anesth Analg. 2007 May;104(5):1108. — View Citation

Niraj G, Searle A, Mathews M, Misra V, Baban M, Kiani S, Wong M. Analgesic efficacy of ultrasound-guided transversus abdominis plane block in patients undergoing open appendicectomy. Br J Anaesth. 2009 Oct;103(4):601-5. doi: 10.1093/bja/aep175. Epub 2009 Jun 26. — View Citation

Raoul S. Etude anatomique du nerf sinus vertébral. Thèse pour le Doctorat en Médecine. Faculté de Médecine de Lille (1996)

Rozen WM, Tran TM, Ashton MW, Barrington MJ, Ivanusic JJ, Taylor GI. Refining the course of the thoracolumbar nerves: a new understanding of the innervation of the anterior abdominal wall. Clin Anat. 2008 May;21(4):325-33. doi: 10.1002/ca.20621. Review. — View Citation

Tran TM, Ivanusic JJ, Hebbard P, Barrington MJ. Determination of spread of injectate after ultrasound-guided transversus abdominis plane block: a cadaveric study. Br J Anaesth. 2009 Jan;102(1):123-7. doi: 10.1093/bja/aen344. — View Citation

Transversus Abdominal Plane Block. 52ème congrès national d'anesthésie et de réanimation. SFAR 2010

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphine consumption	patient-controlled administration	During the first 24 postoperative hours
Secondary	intraoperative sufentanil consumption	infusion adjusted according to heart rate and arterial pressure	At the end of anesthesia
Secondary	Sedation scale	using WHO Sedation scale; - 0 = awake and alert /- 1 = quietly awake / - 2 = asleep but easily roused / - 3 = deep sleep	During the first 6 hours
Secondary	Morphine consumption	patient-controlled administration	between the 24 and the 48 postoperative hours
Secondary	Postoperative nausea and vomiting (PONV) Score	Measure the presence and severity of postoperative nausea and vomiting the PONV score :- 1 = mild /- 2 = moderate / - 3 = severe	first 24 postoperative hours
Secondary	Antiemetics consumption		During the first 24 postoperative hours
Secondary	resumption of intestinal transit		Up to the end of hospital stay
Secondary	visual analog scale	Measure the pain severity	At Baseline, at wake up, during the first 48 postoperative hours, At 3 and 6 months after surgery
Secondary	Area peri-incisional hyperalgesia	von frey's hair	At 48 hours
Secondary	Questionnaire Douleur de Saint-Antoine (QDSA) ,	evaluation with validated scores for chronic and neuropathic pains	At Baseline, At 3 and 6 months after surgery
Secondary	Questionnaire d'Evaluation des Douleurs Neuropathiques (QEDN),	evaluation with validated scores for chronic and neuropathic pains	At Baseline, At 3 and 6 months after surgery
Secondary	Sullivan's "pain catastrophising scale",	evaluation with validated scores for chronic and neuropathic pains	At Baseline, At 3 and 6 months after surgery
Secondary	Hospital Anxiety and Depression Scale (HAD scale),	evaluation with validated scores for chronic and neuropathic pains	At Baseline, At 3 and 6 months after surgery
Secondary	Oswestry score	evaluation with validated scores for chronic and neuropathic pains	At Baseline, At 3 and 6 months after surgery