Istinye University Hospital
Istanbul, Turkey (Türkiye)
Location status: Recruiting
Location contact
Ali Sait Kavakli, M.D.
PRINCIPAL_INVESTIGATOR
Taylan Sahin, M.D.
CONTACT
Taylan Sahin, M.D.
PRINCIPAL_INVESTIGATOR
Recruiting
NCT Number: NCT06976320
Deep Rectus Sheath Block for Laparoscopic Cholecystectomy
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–80 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
Patients scheduled for elective laparoscopic gastrectomy will be separated into 2 groups: Control Group and Deep Rectus Sheath Block Group. Patients in Control Group will be received patient controlled analgesia with morphine for postoperative analgesia. Patients in Deep Rectus Sheath Block Group will be performed Deep Rectus Sheath Block at the end of the surgery, along with patient controlled analgesia with morphine for postoperative analgesia. Morphine consumption for first postoperative 24 hours, numerical rating scale scores, amount of rescue analgesic drug, incidence of postoperative nausea and vomiting will be recorded.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Age between 18 and 80 years
- Patients with American Society of Anesthesiology (ASA) physical status I-II
- Patients scheduled for a laparoscopic cholecystectomy
Exclusion criteria
- Allergy to local anesthetics
- Coagulopathy
- Skin infection at the deep rectus sheath block area
- Advanced hepatic or renal failure
- Chronic pain syndromes
- Alcohol or drug abuse
- Severe pulmonary and/or cardiovascular disease
- Psychiatric disorders
Treatment and study plan
Intravenous morphine patient control analgesia
Other24-hour morphine consumption will be recorded
Intravenous patient control analgesia
Other24-hour morphine consumption will be recorded
Deep rectus sheath block
OtherDeep rectus sheath block will be administered at the end of the surgery.
Primary outcomes
-
Morphine consumption
Time frame: Postoperative 24 hours
The amount of morphine required by the patient and given by the device will be recorded for the first 24 hours.
Secondary outcomes
-
Postoperative numerical rating scale scores
Time frame: Postoperative 24 hours
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.
-
Rescue analgesic drug requirement
Time frame: Postoperative 24 hours
The amount of rescue analgesic in mg required by the patient will be recorded for the first 24 hours.
-
Incidence of postoperative nausea and vomiting
Time frame: Postoperative 24 hours
Number of patients developing postoperative nausea and vomiting will be recorded for the first 24 hours
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Istinye University
Other
Registry information
Official study title
Deep Rectus Sheath Block for Postoperative Analgesia in Patients Undergoing Laparoscopic Cholecystectomy
Important dates
- Study start
- 2025
- Primary completion
- 2025
- Study completion
- 2026
- First posted
- May 16, 2025
- Registry last updated
- Sep 22, 2025
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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