Intraoperative Nociception and Postoperative Pain

the Prediction of Postoperative Pain With Surgical Incision Stimulation in the Patients Undergoing Gastrectomy

If the individual patient's pain is assessed and the amount of analgesic needed after surgery is predicted, appropriate injection of pain control and excessive injection of narcotic analgesic can be prevented. Therefore, investigators try to evaluate the relation intraoperative nociception response with postoperative pain score.

In similar anesthetic depth(End tidal sevoflurane 3%) , changes of surgical pleth index values for stimulus of skin incision are thought to reflect the individual nociception characteristics.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Nociceptive Pain; Analgesics
• Intervention / Treatment: Device: SPI group

Detailed Description

Patients who undergoing upper abdominal laparotomy surgery usually experience severe postoperative pain. Previous studies were reported that preoperative pain, young age, high-dose remifentanil, and depression were associated with severe postoperative pain.

However, anesthesia-related studies were either retrospective studies or injected with anesthetic agents in excess of clinical doses to differentiate between groups. There is no objective indicator for prediction severe postoperative pain.The purpose of this study was to investigate the relationship between intraoperative pain response and postoperative pain on standardized surveillance devices.

To maintain the depth of anesthesia, an EEG monitoring device bispectral index (BIS) is used. Also, surgical pleth index (SPI, GE healthcare, Freiburg, Germany) is a noninvasive pain-analgesia balance monitoring device that is commercially available to evaluate the state of pain during general anesthesia. SPI = 100- (0.3 * heart beat interval + 0.7 * photoplethysmographic pulse wave amplitude) is automatically and continuously calculated from the waveform of peripheral oxygen saturation.

In similar anesthetic depth(End tidal sevoflurane 3%) , changes of SPI values for stimulus of skin incision are thought to reflect the individual nociception characteristics. The investigators hypothesized the higher analgesics consumption can predict with high SPI response following incisional stimuli.

Thus, investigators try to evaluate the comparison of two groups ( high fentanyl consumption group vs. low fentanyl consumption group) with intraoperative SPI value (incision and before aurosal) and hemodynamic parameters under End tidal sevoflurane 3%(anesthesia depth, hemodynamically stable and appropriate anesthetic depth based on previous studies were confirmed at the time of skin incision). And the characteristics and emotional status of patients in two groups are compared.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

the 20-80 year old patients who undergoing lapatotomy gastrectomy at samsung medical center

Description

Inclusion Criteria:

-undergoing laparotomy gastrectomy

Exclusion Criteria:

• cardiac arrythmia
• allergic history for drugs
• renal failure (Cr> 1.5 mg/dl)

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SPI group; All patients who received the liver resection surgery will receive surgical pleth index	Device: SPI group; All patients applied surgical pleth index at the time of surgical incision, under End tidal Sevoflurane 3%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The requirement of postoperative analgesics for postoperative 24 hours	The requirement of postoperative analgesics for postoperative 24 hours (opioid conversion to fentanyl dose mcg)	postoperative 24 hour
The immediate postoperative pain score	The numeric rating pain score, no pain=0 ~ worst pain=10	postoperative 24 hour
intraoperative nociception score (surgical pleth index)	under End tidal sevoflurane 3%, surgical pleth index score following surgical incision	intraoperative at the time of skin incision

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The correlation of requirement of summed postoperative analgesics and intraoperative nociception score	The consumption of analgesics (opioid conversion to fentanyl dose mcg) and intraoperative surgical pleth index value	postoperative 1 hour
The correlation of highest postoperative pain score and intraoperative nociception score	The postoperative pain score (numeric rating pain score, no pain=0~ worst pain=10)and intraoperative surgical pleth index score	postoperative 1 hour

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The expectation of postoperative pain	The postoperative pain score (numeric rating pain score, no pain=0~ worst pain=10)	The day before surgery
The expectation of analgesics consumption	less than average, average, more than average	The day before surgery

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Publications and helpful links

General Publications

• Ledowski T, Burke J, Hruby J. Surgical pleth index: prediction of postoperative pain and influence of arousal. Br J Anaesth. 2016 Sep;117(3):371-4. doi: 10.1093/bja/aew226.
• Schreiber KL, Martel MO, Shnol H, Shaffer JR, Greco C, Viray N, Taylor LN, McLaughlin M, Brufsky A, Ahrendt G, Bovbjerg D, Edwards RR, Belfer I. Persistent pain in postmastectomy patients: comparison of psychophysical, medical, surgical, and psychosocial characteristics between patients with and without pain. Pain. 2013 May;154(5):660-668. doi: 10.1016/j.pain.2012.11.015. Epub 2012 Dec 5.
• Robertson TC, Hall K, Bear S, Thompson KJ, Kuwada T, Gersin KS. Transversus abdominis block utilizing liposomal bupivacaine as a non-opioid analgesic for postoperative pain management. Surg Endosc. 2019 Aug;33(8):2657-2662. doi: 10.1007/s00464-018-6543-z. Epub 2018 Nov 2.
• Baron-Stefaniak J, Gotz V, Allhutter A, Schiefer J, Hamp T, Faybik P, Berlakovich G, Baron DM, Plochl W. Patients Undergoing Orthotopic Liver Transplantation Require Lower Concentrations of the Volatile Anesthetic Sevoflurane. Anesth Analg. 2017 Sep;125(3):783-789. doi: 10.1213/ANE.0000000000002250.

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2018
• Primary Completion (Actual): May 20, 2019
• Study Completion (Actual): May 20, 2019

Study Registration Dates

• First Submitted: November 27, 2018
• First Submitted That Met QC Criteria: November 29, 2018
• First Posted (Actual): December 3, 2018

Study Record Updates

• Last Update Posted (Actual): July 12, 2019
• Last Update Submitted That Met QC Criteria: July 10, 2019
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Nociceptive Pain
• Other Study ID Numbers: SMC2018-11-118

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No