The Application of Transversus Abdominis Plane Block Plus Rectus Sheath Block in Clinical Anesthesia

NCT02984865 | Unknown DMC

• 1 other identifier: PJ-2016-09-05
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

Brief Summary

Peritoneal dialysis (PD) catheter placement surgery for patients with end-stage renal disease (ESRD) can be performed under peripheral nerve block. This study assessed the ability of ultrasound guided left lateral transversus abdominis plane (TAP) block combined with rectus sheath (RS) block in PD catheter placement surgery. Also, surgeries are common surgeries performed in elderly patients throughout the world. Although there is an increasing trend towards laparoscopic surgeries, open procedures continue to remain common therapeutic modalities especially in the developing countries. Pain is reported more commonly in patients undergoing open procedures than laparoscopic procedures. Postoperative pain and tissue injury associated with surgery initiated a systemic stress response which has neuroendocrine, immunological, and haematological responses. Opioids are an important modality of postoperative pain management. They blunt the neuroendocrine stress response to pain. However, they are associated with several adverse effects like respiratory depression, nausea, vomiting , pruritus, constipation, urinary retension, bradycardia and hypotension. Transversus abdominis plane block（TAPB）is a relative novel procedure in which local anesthetic agents are injected into the anatomic plane between the internal oblique and the transversus abdominis muscle. It allows a significantly prolonged duration of analgesia during the early postoperative stage in abdominal surgery. This regional anesthesia technique provides analgesia to the skin, muscles of the anterior abdominal wall and parietal peritoneum in order to decrease the incision-related pain. Thus, it reduces postoperative opiate requirements and opioids-related side effects (nausea, vomiting, delayed resumption of intestinal transit, drowsiness, respiratory depression, urine retention). Nalbuphine, being mu antagonist an kappa agonist, has a ceiling effect in its respiratory depression. Many studies have reported that incidence of adverse effects like pruritus and PONV is lower with nalbuphine in comparison with morphine. The purpose of this study is to compare the analgesic efficacy and side effect profile of sulfentanyl with nalbuphine in elderly patients undergoing open gastrointestinal surgeries.

Conditions

Postoperative Nausea and Vomiting; Surgery; Anesthesia; Peritoneal Dialysis; Rectus Sheath Block

Keywords

transversus plane block; opioid; nalbuphine; gastrointestinal surgery; elderly patient; rectus sheath block; Peritoneal dialysis

Outcome Measures

Primary Outcomes (2)

• postoperative nausea and vomiting

  48 hours after surgery

• verbal rating scale

  during surgery

Secondary Outcomes (3)

• postoperative visual analogue scale of pain

  48 hours after surgery

• postoperative Ramsay of sedation

  48 hours after surgery

• first time for out of bed activity after surgery

  7days after surgery

Study Arms (5)

group S

ACTIVE COMPARATOR

Patients were attach with PCA containing 100ml combination of sulfentanyl 2.5ug/kg and flubiprofen axetil 100mg after receiving the loading dose of sulfentanyl 5 ug and flubiprofen axetil 50mg intravenously 30 mins before the end of the operation .

Drug: Sulfentanyl; Drug: flubiprofen axetil

group N1

EXPERIMENTAL

Patients were attach with PCA containing 100ml combination of nalbuphine 1.5mg/kg and flubiprofen axetil 100mg after receiving the loading dose of nalbuphine 5 mg and flubiprofen axetil 50mg intravenously 30 mins before the end of the operation .

Drug: Nalbuphine; Drug: flubiprofen axetil

group N2

EXPERIMENTAL

Patients were attach with PCA containing 100ml combination of nalbuphine 2mg/kg and flubiprofen axetil 100mg after receiving the loading dose of nalbuphine 5 mg and flubiprofen axetil 50mg intravenously 30 mins before the end of the operation .

Drug: Nalbuphine; Drug: flubiprofen axetil

group N3

EXPERIMENTAL

Patients were attach with PCA containing 100ml combination of nalbuphine 2.5mg/kg and flubiprofen axetil 100mg after receiving the loading dose of nalbuphine 5 mg and flubiprofen axetil 50mg intravenously 30 mins before the end of the operation .

Drug: Nalbuphine; Drug: flubiprofen axetil

Group ESRD

OTHER

30 patients with ESRD who underwent PD catheter placement using left lateral transversus abdominis plane (TAP) block combined with rectus sheath (RS) block from our center. The TAP and RS blocks were respectively conducted with 15 ml of 0.5% ropivacaine and 10 ml of 0.5% ropivacaine. Pain intensity was evaluated by verbal rating scale (VRS), and the degree of patient and surgeon satisfaction was qualified by a categorical scale.

Procedure: rectus sheath block

Interventions

Sulfentanyl DRUG

Also known as: sulfentanil

group S

Nalbuphine DRUG

group N1; group N2; group N3

flubiprofen axetil DRUG

group N1; group N2; group N3; group S

rectus sheath block PROCEDURE

Transversus abdominis plane (TAP) block combined with rectus sheath (RS) block will be applied in Group ESRD

Group ESRD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with ESRD scheduled for PD catheter placement belonging to American Society of Anesthesiologists (ASA) Grade 2 to 4 were included in the study.
• Elderly patients who were over 65 years old ,undergoing open gastrointestinal surgeries were included in the study.

Sponsors & Collaborators

• The First Affiliated Hospital of Anhui Medical University: lead

Study Sites (1)

the First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230032, China

RECRUITING

Related Publications (7)

• Lissauer J, Mancuso K, Merritt C, Prabhakar A, Kaye AD, Urman RD. Evolution of the transversus abdominis plane block and its role in postoperative analgesia. Best Pract Res Clin Anaesthesiol. 2014 Jun;28(2):117-26. doi: 10.1016/j.bpa.2014.04.001. Epub 2014 May 9.

  PMID: 24993433 BACKGROUND

• Zeng Z, Lu J, Shu C, Chen Y, Guo T, Wu QP, Yao SL, Yin P. A comparision of nalbuphine with morphine for analgesic effects and safety : meta-analysis of randomized controlled trials. Sci Rep. 2015 Jun 3;5:10927. doi: 10.1038/srep10927.

  PMID: 26039709 BACKGROUND

• Kartalov A, Jankulovski N, Kuzmanovska B, Zdravkovska M, Shosholcheva M, Spirovska T, Petrusheva AP, Tolevska M, Srceva M, Durnev V, Jota G, Selmani R, Sivevski A. Effect of Adding Dexamethasone as a Ropivacaine Adjuvant in Ultrasound-Guided Transversus Abdominis Plane Block for Inguinal Hernia Repair. Pril (Makedon Akad Nauk Umet Odd Med Nauki). 2015;36(3):35-41. doi: 10.1515/prilozi-2015-0076.

  PMID: 27442394 BACKGROUND

• Huang D, Ma X, Zhou D. [Effects of postoperative analgesia of ultrasound-guided transversus abdominis plane block in hemicolectomy patients]. Zhonghua Yi Xue Za Zhi. 2014 Jun 3;94(21):1623-6. Chinese.

  PMID: 25152283 BACKGROUND

• Akshat S, Ramachandran R, Rewari V, Chandralekha, Trikha A, Sinha R. Morphine versus Nalbuphine for Open Gynaecological Surgery: A Randomized Controlled Double Blinded Trial. Pain Res Treat. 2014;2014:727952. doi: 10.1155/2014/727952. Epub 2014 Apr 14.

  PMID: 24834352 BACKGROUND

• Dai W, Lu Y, Liu J, Tang L, Mei B, Liu X. Ultrasound-guided left lateral transversus abdominis plane block combined with rectus sheath block in peritoneal dialysis catheter placement. J Anesth. 2018 Aug;32(4):645-648. doi: 10.1007/s00540-018-2528-2. Epub 2018 Jul 5.

  PMID: 29978298 DERIVED

• Mao Y, Cao Y, Mei B, Chen L, Liu X, Zhang Z, Gu E. Efficacy of Nalbuphine with Flurbiprofen on Multimodal Analgesia with Transverse Abdominis Plane Block in Elderly Patients Undergoing Open Gastrointestinal Surgery: A Randomized, Controlled, Double-Blinded Trial. Pain Res Manag. 2018 Jan 28;2018:3637013. doi: 10.1155/2018/3637013. eCollection 2018.

  PMID: 29623143 DERIVED

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Sufentanil; Nalbuphine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Xuesheng Liu, Doctor

  The First Affiliated Hospital of Anhui Medical University

  STUDY DIRECTOR

Central Study Contacts

Yu Mao, postgraduate

CONTACT

+86 18019951656; maoyu163flying@163.com

Erwei Gu, bachelor

CONTACT

+8613966663478; ay_guew_mz@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The first group was designed to observe the advantage of transversus abdominis plane (TAP) block combined with rectus sheath (RS) block in PD catheter placement surgery, which is independent from other 4 groups.

Study Record Dates

• First Submitted: November 30, 2016
• First Posted: December 7, 2016
• Study Start: December 20, 2016
• Primary Completion: April 8, 2018
• Study Completion: May 1, 2018
• Last Updated: February 22, 2018

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)