An interventional study of Superficial cervical nerve block and NSAID in Relieve Shoulder Pain After Laparoscopic Surgeries, sponsored by Makassed General Hospital. Completed at 1 site in Lebanon. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-11-06.
Sponsored by Makassed General Hospital · Not applicable, Interventional, and Treatment
Shoulder pain is frequently mentioned in recent literature following laparoscopic operations. Several pain relief strategies have been proposed to decrease shoulder tip pain post laparoscopic surgeries. This study will be conducted to compare the Superficial cervical nerve block vs. NSAIDs in terms of shoulder tip pain relief after laparoscopic surgeries.
The study will be conducted in the operating room and post anesthesia care unit (PACU) at Makassed General Hospital. This is a prospective double blind randomized clinical trial that will be conducted between June 2016 and June 2017 at Makassed General Hospital. Following the Institutional Review Board (IRB) approval, written informed consent will be obtained from patients. Patients will be randomly assigned using the sealed envelope technique into 2 groups. Group I will receive superficial cervical nerve block and intravenous saline. Group II will receive saline superficial cervical block and intravenous NSAID (Profenid).
All patients will receive general anesthesia. General anesthesia is induced with 1 μg/kg fentanyl, 1.5-2 mg/kg propofol and 1-2 mg midazolam. Then, endotracheal intubation is facilitated by 0.15 mg/kg nimbex. Anesthesia is maintained by 1-1.5% sevoflurane, 0.5 μg/kg/h fentanyl, 0.05 mg/kg/h nimbex, 60% nitrous oxide and 40% oxygen. Any hemodynamic change of 25% results in a gradual increase or decrease of the sevoflurane concentration.
707 studies on the registry are indexed under Shoulder Pain; 152 are open to participants now.
This study's enrollment of 60 is close to the median of 60 across 561 interventional studies indexed under Shoulder Pain.
Browse Shoulder Pain studies →Makassed General Hospital is the lead sponsor of 38 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
cholecystectomy, sleeve gastrectomy, mini bypass surgery, gastric plication
Exclusion Criteria:
Patients will receive superficial cervical nerve block in which we inject 5 ml of local anaesthetic mixture. Each 17 ml of the mixture contain: 6 ml lidocaine 2%, 6 ml lidocaine 2% with adrenaline 5 µg/ml, and 5 ml bupivacaine 0.5. Patients will also receive 100 ml IV saline.
Other: Superficial cervical nerve block · Other: General anesthesia · Other: IV placebo
Patients will receive 100 mg (100 ml) IV NSAIDs (Profenid) before induction of anesthesia. Superficial cervical nerve block containing 5 ml placebo will be performed.
Other: NSAID · Other: General anesthesia · Other: Placebo superficial cervical nerve block
A nerve stimulator is used to guide superficial cervical blockade to relieve shoulder pain.
100 mg (100 ml) intravenous NSAIDs (Profenid)
General anesthesia is induced with 1 μg/kg fentanyl, 1.5-2 mg/kg propofol and 1-2 mg midazolam. Then, endotracheal intubation is facilitated by 0.15 mg/kg nimbex. Anesthesia is maintained by 1-1.5% sevoflurane, 0.5 μg/kg/h fentanyl, 0.05 mg/kg/h nimbex, 60% nitrous oxide and 40% oxygen
100 ml IV saline
Superficial cervical nerve block containing 5 ml saline
Pain scores assessed through the Visual Analogue Scale (VAS)
Time frame: 48 hours postoperatively
Number of patients receiving analgesics
Time frame: 48 hours postoperatively
Length of hospital stay
Time frame: An average of 24 hours
This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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Makassed General Hospital