Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01828424
Other study ID # CER 12-262
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 2013
Est. completion date June 2017

Study information

Verified date September 2019
Source University Hospital, Geneva
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

There is a large variability of postoperative pain intensity and of the drug doses necessary to alleviate this pain. The investigators hypothesis is that a measurement of nociception at the end of surgery, using either the RIII reflex threshold, measures of heart rate variability or the pupil dilatation reflex measured by pupillometry, in relation to the doses of opioids used intraoperatively will yield a prediction of postoperative pain.


Description:

Acute postoperative pain needs to be alleviated quickly to avoid sensitization in the postoperative period, since sensitization can lead to pain chronification. Severe acute postoperative pain is the most important risk factor in the development of persistent postoperative pain.

Unfortunately, the dose of opioids necessary to alleviate postoperative pain is highly variable, even between patients having been exposed to the same surgical procedure. Anesthesiologists usually try to prevent immediate postoperative pain by adjusting analgesic dosing at the end of surgery to the perceived need of analgesia. However, this approach is limited by the problem of respiratory depression induced by a too large dose of opiate analgesics. Studies have shown that despite these attempts many patients awake with moderate to severe pain.

A means of predicting immediate postoperative pain after surgery and the response to opiate analgesics would therefore be highly desirable. Many studies have tried to reveal predictive factors which can be evaluated before the start of the surgery, but these can explain only about 50% of the observed variability in postoperative pain intensity.

A different approach may be the evaluation of intraoperative nociception at the end of surgery to directly guide appropriate analgesia before the patient has regained consciousness. Measuring reflex pupil dilation after a standardized electrical stimulus is one method to measure opioid effect intra-operatively. This parameter may reflect opioid sensitivity, but not pain sensitivity.

The primary objective of this study is the evaluation of measures of nociception such as the pupillary dilation reflex or heart rate variability on acute pain after surgery.

In addition, pupillary dilation reflex and heart rate variability will be evaluated in their predictive performance of blood pressure and heart rate changes due to intubation.

The study is designed as a single centre, observational, descriptive study.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date June 2017
Est. primary completion date June 2017
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- American Society of Anesthesiology (ASA) physical status less than 3

- Able to read and understand the information sheet and to sign and date the consent form

- Being scheduled for elective gynaecological intraperitoneal surgery (laparoscopy, laparoscopic hysterectomy, vaginal hysterectomy, abdominal hysterectomy) under general anesthesia

- Age>18

Exclusion Criteria:

- Regional anesthesia (epidural analgesia, multi-orifice wound catheter, or transversus abdominis plane block) used for postoperative analgesia

- Surgery performed under regional anesthesia

- Contraindication to a general anesthesia using propofol and sufentanil (e.g. necessity for rapid sequence induction)

- BMI >35 (limit of the equations used in the target controlled infusion device)

- Severe renal insufficiency precluding use of morphine (GFR<30 ml/min)

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Switzerland Hôpitaux Universitaires de Genève Geneva

Sponsors (2)

Lead Sponsor Collaborator
Benno Rehberg-Klug University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

von Dincklage F, Hackbarth M, Mager R, Rehberg B, Baars JH. Monitoring of the responsiveness to noxious stimuli during anaesthesia with propofol and remifentanil by using RIII reflex threshold and bispectral index. Br J Anaesth. 2010 Feb;104(2):201-8. doi: 10.1093/bja/aep357. Epub 2009 Dec 22. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary pain upon arrival in the recovery room presence or absence of pain reported by the patient upon arrival in the recovery room 20 minutes
Primary opioid effect Opioid effect as defined on a scale of -1 to +1:
"+1" =pain intensity >3 upon arrival in the recovery room, necessitating treatment "0" = pain intensity <=3 upon arrival in the recovery, no respiratory depression at the time of stop of the sufentanil infusion (respiratory frequency immediately >8/min) "-1" = pain intensity <=3 upon arrival in the recovery, time to a steady respiratory frequency of >8/min is less than 20 min (=mean of all patients) from time of stop of the sufentanil infusion. This outcome will be used as primary outcome if less than 20% of patients report a pain intensity of >3 upon arrival in the recovery room.
20 minutes
Secondary respiratory depression The time from the stop of the sufentanil infusion until a steady respiratory rate of >8/min has been reached 20 minutes
Secondary cumulative morphine dose The cumulative morphine at 2h, 12h and at 24h after the end of surgery (intravenous nurse administered doses in the recovery room and consumption measured by the patient-controlled analgesia pump) 24 hours
Secondary systolic blood pressure increase after intubation change in systolic blood pressure during the 3 minutes following intubation compared to the 3 minutes before intubation 6 minutes
Secondary heart rate increase after intubation change in heart rate during the 3 minutes following intubation compared to the 3 minutes before intubation 6 minutes
Secondary mean pain intensity first 24h mean of the 3 pain intensity measurements on the ward during the first 24 postoperative hours, after discharge from the recovery room 24h
See also
  Status Clinical Trial Phase
Completed NCT05926817 - Effect of Virtual Reality on Patients With Acute Pain After Thoracoscopic Surgery N/A
Completed NCT05351203 - Ultrasound Guided Bilateral Erector Spinae Block Versus Caudal in Lumbar Spine Surgeries N/A
Completed NCT05386095 - Axillary Brachial Plexus Block Using 0.25% Bupivacaine Versus Using 0.19%Bupivacaine in Pediatrics N/A
Completed NCT05364216 - Effect of TPVB on Postoperative Pain and Cognitive Function After VATS in Elderly Patients N/A
Completed NCT04875390 - Erector Spina Plane (ESP) Block in Pediatric Patients N/A
Recruiting NCT06381401 - Bupivacaine 0.125% Versus Bupivacaine 0.25% in Superficial Cervical Plexus Block for Tympanomastoid Surgeries in Adults Phase 4
Completed NCT05068037 - Influence of Hypnoacupuncture on Early Perioperative Recovery N/A
Completed NCT04169256 - Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profile of HYR-PB21 in Healthy Volunteers Phase 1
Completed NCT04855240 - Evaluate the Efficacy and Safety of ACP-044 for the Treatment of Acute Postoperative Pain Following Bunionectomy Phase 2
Recruiting NCT06381063 - Non-steroidal Anti-inflammatory in Cardiac Surgery N/A
Completed NCT02107339 - Methadone and Hydromorphone For Spinal Surgery Phase 4
Recruiting NCT06281275 - A Study of the Association Between Frailty and Acute Postoperative Pain in Elderly Thoracoscopic Surgery Patients
Not yet recruiting NCT06088602 - Cryoneurolysis for Acute Postoperative Pain Following Total Knee Arthroplasty N/A
Not yet recruiting NCT04775992 - Preemptive Analgesia of Gabapentoids in Orthopedic Surgery
Active, not recruiting NCT05260008 - Study Assessing Pain Relief After Replacement of the Knee Phase 2
Not yet recruiting NCT05865366 - Pain Trajectories and Predictors After Noncardiac Surgery in Elderly Patients
Recruiting NCT04033471 - Combined Epidural Morphine and Midazolam on Postoperative Pain Phase 1/Phase 2
Completed NCT03903224 - Combined PECS II and Transversus Plane Blocks Versus Erector Spinae Block in Modified Radical Mastectomy N/A
Completed NCT02115945 - Femoral and Epidural Block After Total Knee Arthroplasty Phase 0
Completed NCT05096468 - Esketamine Combined With Pregabalin on Acute Postoperative Pain in Patients Undergoing Resection of Spinal Neoplasms. Phase 2/Phase 3