Intraoperative Administration of Intravenous Morphine in Patients Undergoing Laparoscopic Cholecystectomy

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21+
SponsorEsbjerg Hospital - University Hospital of Southern Denmark

About this trial

The goal of this observational, quality improvement study is to compare the effect of a dose of morphine given during gall-bladder removal surgery. The main questions to answer are:

* Do participants, who are given given a dose of morphine during gall-bladder removal surgery, experience less pain after surgery? * Does a dose of morphine during gall-bladder removal surgery cause more side effects? The investigators will compare the effects of two types of anesthesia: a) anesthesia without morphine during surgery, and b) anesthesia with morphine during surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

patients who have had elective laparoscopic cholecystectomy/planned gall-bladder removal surgery

Disqualifiers

age limit as above

patients unable to give consent to anesthesia

patients unable to participate in pain scoring

patients with chronic pain syndromes, characterized by patients receiving regular analgesic treatment and patients with active or previous contact to pain clinic)

Trial population

Surgery performed at Hospital og South West Jutland, Esbjerg in main operating facilities.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Intraoperative morphine

    Procedure/Surgery

    Morphine dose = 0,1 mg mg/kg (maximum 10 mg) intravenous given 20 min after start of surgery

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: No morphine0 interventions
Group B: Morphine1 intervention

Trial outcomes

Primary outcomes

1

Use of rescue analgesia.

Calculated as morphine equivalents.

Time frame
24 hours

Secondary outcomes

1

Intraoperative opioid use.

Calculated as morphine equivalents.

Time frame
24 hours
2

Pain-score at arrival in postoperative ward.

Intervals: 0 = no pain, 1 = light pain (equivalent to numerical ranking scale (NRS) 1-3), 2 = moderate pain (equivalent to NRS 4-6), 3 = severe pain (equivalent to NRS 7-10).

Time frame
24 hours
3

Pain-score at discharge from postoperative ward.

Intervals: 0 = no pain, 1 = light pain (equivalent to NRS 1-3), 2 = moderate pain (equivalent to NRS 4-6), 3 = severe pain (equivalent to NRS 7-10).

Time frame
24 hours
4

Rescue antiemetic treatment in postoperative ward.

Antiemetic drugs and doses registered.

Time frame
Up to 24 hours follow up.

Other outcomes

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