Intraoperative Nociception and Postoperative Pain

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03761433
• Other study ID #: SMC2018-11-118
• Status: Completed
• Start date: November 30, 2018
• Est. completion date: May 20, 2019

Study information

• Verified date: November 2018
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 20, 2019
• Est. primary completion date: May 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

-undergoing laparotomy gastrectomy

Exclusion Criteria:

• cardiac arrythmia

• allergic history for drugs

• renal failure (Cr> 1.5 mg/dl)

Related Conditions & MeSH terms

• Analgesics
• Nociceptive Pain
• Pain, Postoperative

Intervention

Device:
• SPI group
All patients applied surgical pleth index at the time of surgical incision, under End tidal Sevoflurane 3%

Locations

Country	Name	City	State
Korea, Republic of	Samsung medical center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (4)

Baron-Stefaniak J, Götz V, Allhutter A, Schiefer J, Hamp T, Faybik P, Berlakovich G, Baron DM, Plöchl 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. — View Citation

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. — View Citation

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. 2018 Nov 2. doi: 10.1007/s00464-018-6543-z. [Epub ahead of print] — View Citation

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):660-8. doi: 10.1016/j.pain.2012.11.015. Epub 2012 Dec 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The expectation of postoperative pain	The postoperative pain score (numeric rating pain score, no pain=0~ worst pain=10)	The day before surgery
Other	The expectation of analgesics consumption	less than average, average, more than average	The day before surgery
Primary	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
Primary	The immediate postoperative pain score	The numeric rating pain score, no pain=0 ~ worst pain=10	postoperative 24 hour
Primary	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	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
Secondary	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