Prediction of Postoperative Pain by Measuring Nociception at the End of Surgery

NCT01828424 | Completed

• 1 other identifier: CER 12-262
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Postoperative Pain

Keywords

acute pain

Outcome Measures

Primary Outcomes (2)

• pain upon arrival in the recovery room

  presence or absence of pain reported by the patient upon arrival in the recovery room

  20 minutes

• 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 Outcomes (5)

• respiratory depression

  20 minutes

• cumulative morphine dose

  24 hours

• systolic blood pressure increase after intubation

  6 minutes

• heart rate increase after intubation

  6 minutes

• mean pain intensity first 24h

  24h

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients scheduled for elective gynaecological intraperitoneal surgery (laparascopy, laparoscopic hysterectomy, vaginal hysterectomy, abdominal hysterectomy) under general anesthesia

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Benno Rehberg-Klug: lead
• University Hospital, Geneva: collaborator

Study Sites (1)

Hôpitaux Universitaires de Genève

Geneva, 1211, Switzerland

Location

Related 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.

  PMID: 20031950 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Acute Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Benno Rehberg-Klug, MD

  Department of anesthesiology, HUG

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: médecin adjoint agrégé

Study Record Dates

• First Submitted: April 3, 2013
• First Posted: April 10, 2013
• Study Start: June 1, 2013
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: September 6, 2019

Record last verified: 2019-09

Locations

CH (1)