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NCT Number: NCT06182111

Intraoperative Administration of Intravenous Morphine in Patients Undergoing Laparoscopic Cholecystectomy

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.

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Key information

Conditions

Postoperative Pain Laparoscopic Cholecystectomy Morphine Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital of south West Jutland

Esbjerg, 6700, Denmark

Location status: Recruiting

Location contact

Sanne Vibe Nielsen, MD

CONTACT

[email protected]

About this study

The investigators will use Redcap secure web application (via Open Patient Data Explorative Network, a subsidiary under University Hospital of Odense, Denmark) for data collection and data management.

No sample size has been collected as per the observational design. The investigators expect to include an equal number in each study arm, as there has been no indication of change in indications for surgery type.

The investigators expect to use students T-test for comparison of groups. If possible logistic regression analyses will be undertaken.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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)
  • patients with active or previous substance abuse
  • emergency surgery

Treatment and study plan

Intraoperative morphine

Procedure

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

Primary outcomes

  1. Use of rescue analgesia.

    Time frame: 24 hours

    Calculated as morphine equivalents.

Secondary outcomes

  1. Intraoperative opioid use.

    Time frame: 24 hours

    Calculated as morphine equivalents.

  2. Pain-score at arrival in postoperative ward.

    Time frame: 24 hours

    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).

  3. Pain-score at discharge from postoperative ward.

    Time frame: 24 hours

    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).

  4. Rescue antiemetic treatment in postoperative ward.

    Time frame: Up to 24 hours follow up.

    Antiemetic drugs and doses registered.

  5. Time in postoperative ward.

    Time frame: 24 hours

    Minutes.

  6. Analgesic treatment in surgical ward if admitted

    Time frame: 24 hours

    Only if admitted (a large proportion of patients expected to undergo out-patient procedure). Calculated as morphine equivalents.

  7. Antiemetic treatment in surgical ward.

    Time frame: 24 hours

    Only if admitted (a large proportion of patients are expected to undergo out-patient procedure). Antiemetic drugs and doses registered.

  8. Hospital length of stay.

    Time frame: 1 month

    Only if admitted (a large proportion of patients are expected to undergo out-patient procedure).

  9. Emergence from anesthesia.

    Time frame: 24 hours

    Surrogate measure of emergence from anesthesia time.

Study contacts

Contact information is provided by the study sponsor or research team.

Jonas L Herping, MD

CONTACT

[email protected]

Sanne V Nielsen, MD

CONTACT

[email protected]

+45 28 49 18 25 (private)

Sponsors and collaborators

Lead sponsor

Esbjerg Hospital - University Hospital of Southern Denmark

Other

Registry information

Official study title

Intraoperative Administration of Intravenous Morphine in Patients Undergoing Laparoscopic Cholecystectomy - a Retrospective, Observational, Quality-improvement Study

Acronym: MORPHLAPCHOL

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 26, 2023
Registry last updated
Aug 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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