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

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ClinicalTrials.gov Identifier: NCT02984865
Recruitment Status : Recruiting
First Posted : December 7, 2016
Last Update Posted : February 21, 2018
Sponsor:
Information provided by (Responsible Party):
The First Affiliated Hospital of Anhui Medical University

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.

Condition or disease Intervention/treatment Phase
Postoperative Nausea and Vomiting Surgery Anesthesia Peritoneal Dialysis Rectus Sheath Block Drug: Sulfentanyl Drug: Nalbuphine Drug: flubiprofen axetil Procedure: rectus sheath block Not Applicable

Detailed Description:
This study will be conducted in the department of Anesthesiology of the first affiliated hospital of Anhui Medical University, Hefei city, Anhui province, China. In our part 1, we are plan to observe 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 will be respectively conducted with 15 ml of 0.5% ropivacaine and 10 ml of 0.5% ropivacaine. Pain intensity will be evaluated by verbal rating scale (VRS), and the degree of patient and surgeon satisfaction will be qualified by a categorical scale. In part 2, the sample size was calculated based on the previous data in our hospital using sulfentanyl and flurbiprofen axetil as the opioid analgesic. The rate of postoperative nausea and vomiting(PONV) after surgery was 35%. Keeping the power of the study as 80% and 5% alpha error with the number of pairwise comparisons as 6, a total sample size of 124 was needed to identify a difference of 0.25 in the rate of PONV. Each group would require at least 31 patients. To allow for dropouts, the investigator decided to include 40 patients in each group. Elderly patients who were over 65 years old, undergoing open gastrointestinal surgeries were included in the study. Patients were divided into four groups, that is group S, group N1, group N2 and group N3, based on the drawing of an opaque sealed envelop.The anesthesiologists managing the intraoperative and postoperative courses as well as patients were blinded to the group which they belonged.The drug solution to be used intraoperatively and postoperatively as PCA (patient-controlled analgesia) was prepared by an assistant. Patients were interviewed before surgery and informed written consent was taken form each patient. Patients were shown a VAS (visual analogue score) of 0-10 for pain with 0 being no pain and 10 being worst pain ever felt, and instructed upon the use of PCA (patient-controlled analgesia) before surgery. Patients were subjected to monitoring of ECG, pulse oximetry and invasive blood pressure. 20ml combination of 0.5% ropivacaine and 10mg dexamethasone was injected bilaterally between the internal oblique and transverse abdominis muscles using sonography. All groups received standard general anesthesia.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Application of Transversus Abdominis Plane Block Plus Rectus Sheath Block in Peritoneal Dialysis Catheter Placement and Analgesia Based on Transversus Abdominis Plane Block Combined With κ Receptor Agonist and NSAID(Non-steroidal Anti-inflammatory Drug ) Following Open Gastrointestinal Surgery
Actual Study Start Date : December 20, 2016
Estimated Primary Completion Date : April 8, 2018
Estimated Study Completion Date : May 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: group S
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
Other Name: sulfentanil

Drug: flubiprofen axetil
Experimental: group N1
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
Experimental: group N2
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
Experimental: group N3
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
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
Transversus abdominis plane (TAP) block combined with rectus sheath (RS) block will be applied in Group ESRD




Primary Outcome Measures :
  1. postoperative nausea and vomiting [ Time Frame: 48 hours after surgery ]
  2. verbal rating scale [ Time Frame: during surgery ]

Secondary Outcome Measures :
  1. postoperative visual analogue scale of pain [ Time Frame: 48 hours after surgery ]
  2. postoperative Ramsay of sedation [ Time Frame: 48 hours after surgery ]
  3. first time for out of bed activity after surgery [ Time Frame: 7days after surgery ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Exclusion criteria included patients refusal, history of abdominal surgery, coagulation disorders, allergy to local anesthetic and localized infection on the injection site.
  • The exclusion criteria were patient refusal, respiratory insufficiency,cardiac insufficiency,liver or kidney dysfunction,history of brain disease,local anesthetic allergy, dysfunction of blood coagulation,hemodynamic instability, history of any chronic pain, and history of chronic opioid use.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02984865


Contacts
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Contact: Yu Mao, postgraduate +86 18019951656 maoyu163flying@163.com
Contact: Erwei Gu, bachelor +8613966663478 ay_guew_mz@163.com

Locations
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China, Anhui
the First Affiliated Hospital of Anhui Medical University Recruiting
Hefei, Anhui, China, 230032
Contact: yu mao    +86 18019951656    maoyu163flying@163.com   
Sponsors and Collaborators
The First Affiliated Hospital of Anhui Medical University
Investigators
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Study Director: Xuesheng Liu, Doctor The First Affiliated Hospital of Anhui Medical University

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: The First Affiliated Hospital of Anhui Medical University
ClinicalTrials.gov Identifier: NCT02984865     History of Changes
Other Study ID Numbers: PJ-2016-09-05
First Posted: December 7, 2016    Key Record Dates
Last Update Posted: February 21, 2018
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by The First Affiliated Hospital of Anhui Medical University:
transversus plane block
opioid
nalbuphine
gastrointestinal surgery
elderly patient
rectus sheath block
Peritoneal dialysis

Additional relevant MeSH terms:
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Vomiting
Postoperative Nausea and Vomiting
Nausea
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Nalbuphine
Sufentanil
Flurbiprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action