Postoperative Pain Clinical Trial
Official title:
Efficacy of Ultrasound-Guided Erector Spinae Plan Block on Postoperative Pain After Laparoscopic Cholecystectomy Under General Anesthesia. Randomized, Controlled Trial
NCT number | NCT03398564 |
Other study ID # | 1/12 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 10, 2018 |
Est. completion date | November 30, 2018 |
Verified date | October 2018 |
Source | Al Jedaani Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Laparoscopic cholecystectomy is a widely employed procedure in ambulatory surgery. Pain after
laparoscopic cholecystectomy arises significantly from port site incisions in the anterior
abdominal wall. Innervation of the anterior abdominal wall is segmentally supplied by pain
afferents in the plane of fascia between transversus abdominis and the internal oblique
muscles. Opioids analgesia is used to control postoperative pain, but it carries the risk of
increased nausea and vomiting, ileus and sedation that may delay hospital discharge.
Several techniques have been tried as.neuroaxial narcotics, intraperitoneal lavage of local
anesthetic and transversus abdominis plan (TAP) block and successfully reduced opioid use and
improve postoperative analgesia.
The ultrasound-guided erector spinae plan(ESP) block is a recently described technique which
produces reliable unilateral analgesia at thoraco-lumbar dermatomes. ESP block carries the
advantages of being simple, safe, easily recognizable by ultrasound, and a catheter can be
threaded to extend the duration of analgesia.
Few case series reported the efficacy of (US)-guided ESP blocks in reducing postoperative
pain and opioids consumption.
Because of that, the investigators aimed to test the hypothesis that US-guided ESP blocks can
decrease opioid consumption during the first 24 h after of laparoscopic cholecystectomy in
comparison with the conventional systemic analgesia.
Status | Completed |
Enrollment | 70 |
Est. completion date | November 30, 2018 |
Est. primary completion date | November 30, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 60 Years |
Eligibility |
Inclusion Criteria: - 60 ASA I- II adult patients - 20-60 years old - elective laparoscopic cholecystectomy - Body mass index (BMI) less than 35 - Port sites at or above thoracic T 10 dermatome Exclusion Criteria: - Allergy to amino-amide local anesthetics - Presence of coagulopathy - Local skin infection at the needle puncture sites - Preoperative chronic dependence upon opioid and NSAID medications - Liver or renal insufficiency - History of psychiatric or neurological disease - Deafness - previous open surgery that need the conversion of laparoscopic to open surgery or manipulations more than expected with more tissue trauma - American Society of Anesthesiologists (ASA) above Class II |
Country | Name | City | State |
---|---|---|---|
Saudi Arabia | Al Jedaani group of hospitals | Jeddah | Meccah |
Lead Sponsor | Collaborator |
---|---|
Al Jedaani Hospital |
Saudi Arabia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Morphine consumption | It was calculated as equivalent morphine dose to the opioid analgesia consumed | 24 hours postoperatively. | |
Secondary | Quality of analgesia | comparing visual analog scores (VAS) every two hours after surgery | Every 2 hours for 24 hours postoperatively | |
Secondary | The intraoperative fentanyl | (µg) required during surgery | 2 hours | |
Secondary | equivalent morphine dose in the recovery unit (PACU) | equivalent morphine dose in the recovery unit (PACU) | one hour | |
Secondary | Erector spinae plan block complications | local anesthetic systemic toxicity, vascular injury, and intravascular injection of local anesthetic | 24 hours postoperative |
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