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NCT Number: NCT03035916

Transversus Abdominis Plane Block on Stress Response

This study evaluates the effect of transversus abdominis plane(TAP) block combined with general anesthesia on perioperative stress response in patients undergoing radical gastrectomy. One third of participants will receive TAP block combined with general anesthesia, another one third of participants will receive epidural anesthesia combined with general anesthesia, while the rest will receive only general anesthesia.

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Key information

Conditions

Gastrostomy Fractures, Bone Fractures, Stress Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

China-Japan Union Hospital of Jilin University

Changchun, Jilin, 130000, China

About this study

Clinically, combining epidural with general anaesthesia may confer many advantages to patients undergoing major thoracic, abdominal or orthopaedic surgery. Epidural anaesthesia can attenuate sympathetic hyperactivity and the stress response, maintain bowel peristalsis, spare the use of opioids, and facilitate postoperative feeding and physiotherapy. However, establishing epidural anesthesia is not without risks and contraindications, including refusal by the patient, technical failure, unintentional dural puncture, waist and back pain and local anaesthetic toxicity. When neurologic complications do occur, the resulting morbidity and mortality is considerable. Transversus abdominis plane (TAP) block, is another new regional anesthesia technique, has been introduced as an abdominal wall block capable of providing effective analgesia, reducing opioid consumption, and lessening opioid-related side effects. In addition,TAP block, somewhat as a pre-emptive analgesia approach, is a way of pain intervention before noxious stimulation which has been reported to be potent to attenuate the stress response. Although the analgesia efficiency of TAP block has been widely studied, its effectiveness to suppress stress response has little comparison with classic epidural block and general anesthesia. Unlike epidural anaesthesia, TAP block is easy to administer and lower incidence for side-effects.The investigators hypothesize that the TAP block reduces the stress response of surgery to the similar extent to epidural anaesthesia when combined with a standard general anaesthesia for abdominal surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Consent
  • ASA 1-3
  • No contraindication to epidural or ropivacaine
  • First time surgery for current conditions
  • Not on chronic pain medications or sedative

Exclusion criteria

  • The subject has a known or suspected allergy to opioid analgesics or ropivacaine
  • Emergency patients
  • The subject has know central nervous system disease or neurological impairment
  • The subject has preoperative infection, and a history of immune and endocrine system disease, chemotherapy, or blood transfusion.

Treatment and study plan

Transversus abdominis plane block

Other

Participants in this group receive ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia, 30 minutes later the surgery will be started.

Epidural anesthesia

Other

Participants in the Epidural group receive a epidural block (T8-9) with 2 mL of 1.6% lidocaine as a test dose before induction. After a successful placement of epidural catheter, the block then is established with 5 mL of 0.375% ropivacaine and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery.

Control

Other

The Control group receives standard IV-inhaled general anesthesia.

Primary outcomes

  1. Physiological Parameters: Plasma Concentration of Norepinephrine (NE)

    Time frame: up to 48h after surgery

    Venous blood samples will be collected at certain time points. The blood samples are collected in a pre-chilled tubes in ice and are centrifuged within 90min, and then separated plasma are stored at -80°C until analysis. The NE levels are measured by ELISA kits.

  2. Physiological Parameters: Plasma Concentration of Epinephrine (E)

    Time frame: up to 48h after surgery

    Venous blood samples will be collected at certain time points. The blood samples are collected in a pre-chilled tubes in ice and are centrifuged within 90min, and then separated plasma are stored at -80°C until analysis. The E levels are measured by ELISA kits.

  3. Physiological Parameters: Plasma Concentration of Cortisol (Cor)

    Time frame: up to 48h after surgery

    Venous blood samples will be collected at certain time points. The blood samples are collected in a pre-chilled tubes in ice and are centrifuged within 90min, and then separated plasma are stored at -80°C until analysis. The Cor levels are measured by ELISA kits.

  4. Physiological Parameters: Plasma Concentration of Glucose (Glu)

    Time frame: up to 48h after surgery

    When venous blood are collected, glucose levels are measured immediately by Glucometer.

  5. Hemodynamic Parameters: Heart Rate.

    Time frame: up to 48h after surgery

    Continuous monitoring of heart rate to 48 hours after surgery.

  6. Hemodynamic Parameters: Mean Arterial Pressure(MAP)

    Time frame: up to 48h after surgery

    Continuous monitoring of mean arterial pressure(MAP) to 48 hours after surgery. mean arterial pressure(MAP)＝ (systolic blood pressure＋2×diastolic blood pressure)/3

Secondary outcomes

  1. Anesthetics Consumption: Sufentanil Consumption

    Time frame: during operation

    Intraoperative superaddition of sufentanil was measured.

  2. Questionnaire: Pain Scores at Rest

    Time frame: 1hr, 6hr, 12hr, 24hr, and 48hr after surgery

    Pain scores of the participants will be measured by the Visual Analogue Scale. Measurement of VAS: Draw a 10cm horizontal line on the paper. The VAS were anchored at 0cm(no pain) and 10cm(worst possible pain), the middle part shows varying degrees of pain, the greater of the number, the worse of the pain.

  3. Questionnaire: Pain Scores on Movement

    Time frame: 1hr, 6hr, 12hr, 24hr, and 48hr after surgery

    Pain scores of the participants will be measured by the Visual Analogue Scale. Measurement of VAS: Draw a 10cm horizontal line on the paper. The VAS were anchored at 0cm(no pain) and 10cm(worst possible pain), the middle part shows varying degrees of pain, the greater of the number, the worse of the pain.

  4. Anesthesia Recovery: the Time of First Flatus

    Time frame: Through study completion, an average of 2 weeks

    The time of first flatus was measured after surgery.

  5. Anesthesia Recovery: Number of Participants With Prolonged Hospitalization

    Time frame: Through study completion, an average of 2 weeks

    The percentage of long hospitalization were measured. More than 7 days after surgery is defined as prolonged hospitalization.

  6. Side Effects: Number of Participants With Sedation

    Time frame: up to 48h after surgery

    The state of sedation was evaluated after surgery during first postoperative 48 hours.

  7. Side Effects: Number of Participants With Nausea

    Time frame: up to 48h after surgery

    The state of nausea was evaluated after surgery during first postoperative 48 hours.

  8. Side Effects: Number of Participants With Vomiting

    Time frame: up to 48h after surgery

    The state of vomiting was evaluated after surgery during first postoperative 48 hours.

Sponsors and collaborators

Lead sponsor

Jilin University

Other

Registry information

Official study title

Effect of Transversus Abdominis Plane Block Combined With General Anesthesia on Perioperative Stress Response in Patients Undergoing Radical Gastrectomy: A Double-blind Randomized Controlled Study.

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jan 30, 2017
Registry last updated
Jan 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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