Health TrialsbyHealthPanel

Deep Rectus Sheath Block for Laparoscopic Cholecystectomy

ConditionsCholecystectomy, LaparoscopicAnesthesiaPostoperative Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorIstinye University

About this trial

Postoperative pain after laparoscopic cholecystectomy can be considerable. Regional techniques such as erector spinae plane (ESP) block or transversus abdominis plane (TAP) block may be suitable for patients at increased risk of postoperative pain. The deep rectus sheath block is a novel block which is a modified version of the conventional rectus sheath block. It was reported in a few case reports that, it may be used for postoperative analgesia in patients undergoing laparoscopic cholecystectomy. The aim of this study is to investigate the postoperative analgesic efficacy of deep rectus sheath block in patients undergoing laparoscopic cholecystectomy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 18 and 80 years

Patients with American Society of Anesthesiology (ASA) physical status I-II

Patients scheduled for a laparoscopic cholecystectomy

Disqualifiers

Allergy to local anesthetics

Coagulopathy

Skin infection at the deep rectus sheath block area

Advanced hepatic or renal failure

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intravenous morphine patient control analgesia

    Other intervention

    24-hour morphine consumption will be recorded

  • Intravenous patient control analgesia

    Other intervention

    24-hour morphine consumption will be recorded

  • Deep rectus sheath block

    Other intervention

    Deep rectus sheath block will be administered at the end of the surgery.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Control groupActive comparator 1 intervention
Group B: Deep rectus sheath block groupActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Morphine consumption

The amount of morphine required by the patient and given by the device will be recorded for the first 24 hours.

Time frame
Postoperative 24 hours

Secondary outcomes

1

Postoperative numerical rating scale scores

Postoperative pain will be assessed using a numerical rating scale (NRS) (from 0 = no pain to 10 = maximum possible pain) for the first 24 hours.

Time frame
Postoperative 24 hours
2

Rescue analgesic drug requirement

The amount of rescue analgesic in mg required by the patient will be recorded for the first 24 hours.

Time frame
Postoperative 24 hours
3

Incidence of postoperative nausea and vomiting

Number of patients developing postoperative nausea and vomiting will be recorded for the first 24 hours

Time frame
Postoperative 24 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Istinye University

Lead sponsor

Source ClinicalTrials.gov
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