An interventional study of Saline and Dexamathsone 4mg/ml associated with experimental arm in Pain and Postoperative Care, sponsored by University Tunis El Manar. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-01-02.
Sponsored by University Tunis El Manar · Not applicable, Interventional, and Treatment
This will be a single-center randomized double blind placebo control clinical trial. In the cohort of patients undergoing hand surgery under axillary nerve block, participants are recruited from those who are willing to consent and participate in the study, and will be randomly 1:1 divided into intervention group and placebo group.
After the arrival to the operation room, monitoring including pulse oximetry, electrocardiogram, and noninvasive blood pressure was applied.
An 18 or 16-gauge IV cannula was inserted and Ringer's lactate infusion was started at a rate of 5 mL per kg per hour.
Antibioprophylaxis was systematically administered with 2 grams ofCefazolin 30 minutes before induction.
All patients were given an ultrasound-guided single-injection axillary plexus block by experienced anesthesiologists.
Sedation with 2 mg midazolam intravenously before block was administered.
In the group Dexamethasone (D), patients received axillary plexus block with a 30 ml of a 50/50 mixture of isobaric bupivacaine 0.5% and lidocaine 1%, containing 8 mg of dexamethasone.
In the group control (X), patients received a 30 mlof a 50/50 mixture of isobaric bupivacaine 0.5% and lidocaine 1% containing 2 ml saline solution.
For the axillary plexus block, patients were placed in a supine positionwith the arm in 90° of abduction and the forearm in flexion.A high frequency linear probe was placed on the transverse axis, over the axillary fold.The axillary artery, vein, and nerves surrounding the artery were visualized after scanning distally and proximally. The block needle (50 mm, 22G) was inserted in-plane from anterior to posterior, parallel to the ultrasound probe.It was advanced toward the musculocutaneous nerve (MCN) and local anesthetic was injected.Then, the needle was retracted and redirected deep relative to the axillary artery and local anesthetic was injectedaround the posterior aspect of the axillary artery and finallythe needle was retracted and redirected superficial to the axillary artery and local anesthetic was injected.
Before the surgical incision, the effectiveness of the sensory blockade of the axillary plexus was evaluated by a cold test in the different territories.
Post-operatively, all patients were put on systematic paracetamol 1 g every 6 hours, without exceeding 4 grams per day.
when the postoperative pain score (NRS) was >3/10, intravenous tramadol 100 mg was administered.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's planned enrollment of 60 is close to the median of 66 across 8,493 interventional studies indexed under Pain.
Browse Pain studies →University Tunis El Manar is the lead sponsor of 74 studies on the registry; 12 are open to participants now.
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Age between 18 and 75 years old.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In the cohort of patients undergoing hand surgery, participants are recruited from those who are willing to consent and participate in the study, and will be randomly recruited into intervention group. Intervention group will receive 30 ml of a 50/50 mixture of isobaric bupivacaine 0.5% and lidocaine 1%, containing 8 mg of dexamethasone.
Drug: Dexamathsone 4mg/ml associated with experimental arm
In the cohort of patients undergoing hand surgery, participants are recruited from those who are willing to consent and participate in the study, and will be randomly recruited into placebo group. Control group will receive a 30 ml of a 50/50 mixture of isobaric bupivacaine 0.5% and lidocaine 1%, containing 2 mL of saline solution.
Other: Saline
2 ml saline solution are added to 30 ml of a 50/50 mixture of isobaric bupivacaine 0.5% and lidocaine 1%
Intervention group will receive 30 ml of a 50/50 mixture of isobaric bupivacaine 0.5% and lidocaine 1%, containing 8 mg of dexamethasone.
incidence of Rebound pain
The primary objective is the incidence of rebound pain, which was defined as severe pain (NRS ≥ 7) \[Numerical rate scale from 0 no pain to 10 worst pain\] at the surgical site during the first 48 hours postoperatively.
Time frame: 1 hour postoperatively to 48 hours postoperatively
Pain score at rest
Pain score at rest using NRS \[Numerical Rate Scale from 0 no pain to 10 worst pain
Time frame: hour 1, hour 48 postoperative
Pain score at movement
Pain scores at mouvement using NRS \[Numerical Rate Scale from 0 no pain to 10 worst pain
Time frame: hour 1, hour 48 postoperative
The analgesic consumption
The number of rescue analgesic dose during the first 24 hours
Time frame: hour 1, hour 24 postoperatively
Duration of motor block
The end of motor block was defined by a total flexion of fingers and arm.
Time frame: hour 1 postoperatively, 12 hours after nerve block
Blood glucose level
level of glucose in serum blood
Time frame: after nerve block, 24 hours after surgery
No study locations are listed for this record.
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University Tunis El Manar