An interventional study of External oblique intercostal block and Oblique subcostal TAP block in Bariatric Surgery Candidate, Pain, Postoperative and Narcotic Use, sponsored by Al Mashfa Medical Center. Completed at 1 site in Saudi Arabia. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-28.
Sponsored by Al Mashfa Medical Center · Not applicable, Interventional, and Prevention
Laparoscopic bariatric procedures nowadays are employed under ERAS protocol as an ambulatory surgery. Pain after laparoscopic procedures arises significantly from port site incisions in the anterior abdominal wall, and shoulder pain (referred from visceral pain). Narcotic medications are utilized to manage postoperative pain, but its disadvantages include, increased post-operative nausea and vomiting (PONV), ileus, sedation and delayed hospital discharge.
Oblique subcostal transversus abdominis plane block (OSTAP) had been studied before and found to be effective in reducing post-operative morphine usage and produce good analgesia for about 24hours postoperatively.
The ultrasound-guided external oblique intercostal (EOI) block is a new technique which proved to produce unilateral analgesia at thoracic dermatomes supplying the anterior and lateral aspects of the upper abdomen.
The aim of this study was to test the hypothesis that US-guided EOI blocks can produce more reduction in opioid usage during the first 24 h after of laparoscopic bariatric surgeries when compared to oblique subcostal TAP (OSTAP) block.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 73 is close to the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Al Mashfa Medical Center is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Ultrasound-guided bilateral external oblique intercostal (EOI) using 30 ml of 0.25% bupivacaine hydrochloride and oblique subcostal transverse abdominis plane (OSTAP) block using Placebo (NSS 0.9%) 30 ml combined with bilateral posterior rectus sheath block with 15 ml bupivacaine 0.25%.
Other: External oblique intercostal block · Other: Posterior Rectus sheath block
Ultrasound-guided bilateral oblique subcostal transverse abdominis plane (OSTAP) block using 30 ml of 0.25% bupivacaine hydrochloride and external oblique intercostal (EOI) using Placebo (NSS 0.9%) 30 ml combined with bilateral posterior rectus sheath block with 15 ml bupivacaine 0.25%.
Other: Oblique subcostal TAP block · Other: Posterior Rectus sheath block
EOI block:Under guidance of the linear high frequency transducer, sagittal plane between anterior axillary line and midclavicular line at the level of the 6th rib, In-plane approach between external oblique and intercostal muscles Hydrodissection with 30 ml of 0.25% bupivacaine hydrochloride .
Also known as: EOI
OSTAP block: The needle was inserted in plane through the rectus adjacent to costal margin Once the tip of the needle was visualized in between the rectus muscle and transversus abdominus muscle and negative pressure aspiration was demonstrated, 30 ml bupivacaine 0.25% was deposited within the plane and hydrodissection was noted.
Also known as: OSTAP
Posterior rectus sheath block: Under linear ultrasound probe, the needle was advanced gradually through the rectus muscle posteriorly toward its medial edge, approaching the rectus sheath. After negative aspiration,12.5 mL bupivacaine 0.25% was injected until the rectus muscle was separated from the posterior rectus sheath by hydrodissection.
Also known as: PRSB
24h equivalent oral morphine consumption
Total pethidine consumption, calculated as an equivalent oral morphine dose, during the 24 hours,
Time frame: 24 hour
Numerical rating scale (NRS)
Numerical rating scale (NRS) in the PACU, and on arrival to the ward at 0 hours then at 2, 4, 6, 12, and 24 hours postoperatively(NRS) with 0 = no pain, to 100mm = the worst imaginable pain at the specified time.
Time frame: 24 hours
Quality of recovery 40 score(QoR-40)
Quality of recovery 40 score at 24 hours.Twelve questions measured the comfort state; 9 questions measured the emotional state; 7 questions measured the psychological state; 5 questions measured the physical independence and 7 questions measured the level of pain. Each question received a score of 1 to 5 with a worst possible score of 40 and a best possible score of 200
Time frame: 24 hours
AMBULATION TIME
Time to first independent ambulation
Time frame: 24 hours
Readiness for discharge
time to readiness for discharge were measured according to the modified postoperative discharge scoring system (PADSS). Patients were considered eligible for discharge if they achieved a total score ≥ 9 on the condition that the vital signs parameter score was not less than 2, and none of the other five parameters scored a zero
Time frame: 24 hours
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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