Trial Outcomes & Findings for Comparison Between Ultra Sound Guided Rectus Sheath Block and Field Block for Midline Hernia Repair (NCT NCT03225313)

Results Overview

Evaluation of the intensity of postoperative pain using Visual Analogue Scale (VAS) for pain: 0- 10 Scale; 0 the lowest pain score, 10 the highest pain scale. 0 score: Better pain control achieved. 10 score: Worst pain control achieved. 3 score: Controllable pain control achieved.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

75 participants

Primary outcome timeframe

evaluation of postoperative pain in patients immediately after the procedure.

Results posted on

2021-03-09

Participant Flow

ASA I \& II patients. 25 patient in each group.

Prospective randomized double blinded controlled clinical trial was done with a total number of 75 patients divided into 3 groups .

Participant milestones

Participant milestones
Measure	Control Group normal saline will be injected in the rectus sheath Normal saline: injected into rectus sheath \& locally	Ultra- Sound Rectus Sheath Block Group bupivicaine will be injected in the rectus sheath Bupivacaine Hydrochloride: ultra sound guided injection into the rectus sheath	Local Infilteration Group bupivicaine will be injected locally Bupivacaine Hydrochloride: injected locally
Overall Study STARTED	25	25	25
Overall Study COMPLETED	25	25	25
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control Group n=25 Participants normal saline will be injected in the rectus sheath Normal saline: injected into rectus sheath \& locally	Ultra- Sound Rectus Sheath Block Group n=25 Participants bupivicaine will be injected in the rectus sheath Bupivacaine Hydrochloride: ultra sound guided injection into the rectus sheath	Local Infilteration Group n=25 Participants bupivicaine will be injected locally Bupivacaine Hydrochloride: injected locally	Total n=75 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=75 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=25 Participants	25 Participants n=25 Participants	25 Participants n=25 Participants	75 Participants n=75 Participants
Age, Categorical >=65 years	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=75 Participants
Age, Continuous	44.80 years STANDARD_DEVIATION 9.941 • n=25 Participants	42.20 years STANDARD_DEVIATION 10.464 • n=25 Participants	44.08 years STANDARD_DEVIATION 8.544 • n=25 Participants	43.76 years STANDARD_DEVIATION 9.606 • n=75 Participants
Sex: Female, Male Female	22 Participants n=25 Participants	17 Participants n=25 Participants	19 Participants n=25 Participants	58 Participants n=75 Participants
Sex: Female, Male Male	3 Participants n=25 Participants	8 Participants n=25 Participants	6 Participants n=25 Participants	17 Participants n=75 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Egypt	25 participants n=25 Participants	25 participants n=25 Participants	25 participants n=25 Participants	75 participants n=75 Participants
Body Weight in Kilograms	82.7 Kilogram STANDARD_DEVIATION 13.9 • n=25 Participants	83.7 Kilogram STANDARD_DEVIATION 11.8 • n=25 Participants	82 Kilogram STANDARD_DEVIATION 10.6 • n=25 Participants	82.87 Kilogram STANDARD_DEVIATION 12.115 • n=75 Participants

PRIMARY outcome

Timeframe: evaluation of postoperative pain in patients immediately after the procedure.

Population: Evaluation of the intensity of postoperative pain using Visual Analogue Scale (VAS) for pain: 0- 10 Scale; 0 the lowest pain score, 10 the highest pain scale. 0 score: Better pain control achieved. 10 score: Worst pain control achieved. 3 score: Controllable pain control achieved.

Evaluation of the intensity of postoperative pain using Visual Analogue Scale (VAS) for pain: 0- 10 Scale; 0 the lowest pain score, 10 the highest pain scale. 0 score: Better pain control achieved. 10 score: Worst pain control achieved. 3 score: Controllable pain control achieved.

Outcome measures

Outcome measures
Measure	Local Group n=25 Participants bupivicaine will be injected locally Bupivacaine Hydrochloride: injected locally	Control Group n=25 Participants normal saline will be injected in the rectus sheath Normal saline: injected into rectus sheath \& locally	Ultra- Sound Rectus Sheath Block Group n=25 Participants bupivicaine will be injected in the rectus sheath Bupivacaine Hydrochloride: ultra sound guided injection into the rectus sheath
Immediate Postoperative Pain	6.56 score on a scale Standard Deviation 3.029	7.36 score on a scale Standard Deviation 2.691	1.04 score on a scale Standard Deviation 1.837

PRIMARY outcome

Timeframe: evaluation of postoperative pain in patients at 2 hours after procedure.

Population: Evaluation of the intensity of postoperative pain using Visual Analogue Scale (VAS) for pain: 0- 10 Scale; 0 the lowest pain score, 10 the highest pain scale. 0 score: Better pain control achieved. 10 score: Worst pain control achieved. 3 score: Controllable pain control achieved.

Evaluation of the intensity of postoperative pain using Visual Analogue Scale (VAS) for pain: 0- 10 Scale; 0 the lowest pain score, 10 the highest pain scale. 0 score: Better pain control achieved. 10 score: Worst pain control achieved. 3 score: Controllable pain control achieved.

Outcome measures

Outcome measures
Measure	Local Group n=25 Participants bupivicaine will be injected locally Bupivacaine Hydrochloride: injected locally	Control Group n=25 Participants normal saline will be injected in the rectus sheath Normal saline: injected into rectus sheath \& locally	Ultra- Sound Rectus Sheath Block Group n=25 Participants bupivicaine will be injected in the rectus sheath Bupivacaine Hydrochloride: ultra sound guided injection into the rectus sheath
Postoperative Pain at 2 Hours After Procedure.	5.12 score on a scale Standard Deviation 1.833	6.04 score on a scale Standard Deviation 1.645	1.20 score on a scale Standard Deviation 1.826

PRIMARY outcome

Timeframe: Evaluation of postoperative pain in patients at 6 hours after procedure.

Population: Evaluation of the intensity of postoperative pain using Visual Analogue Scale (VAS) for pain: 0- 10 Scale; 0 the lowest pain score, 10 the highest pain scale. 0 score: Better pain control achieved. 10 score: Worst pain control achieved. 3 score: Controllable pain control achieved.

Evaluation of the intensity of postoperative pain using Visual Analogue Scale (VAS) for pain: 0- 10 Scale; 0 the lowest pain score, 10 the highest pain scale. 0 score: Better pain control achieved. 10 score: Worst pain control achieved. 3 score: Controllable pain control achieved.

Outcome measures

Outcome measures
Measure	Local Group n=25 Participants bupivicaine will be injected locally Bupivacaine Hydrochloride: injected locally	Control Group n=25 Participants normal saline will be injected in the rectus sheath Normal saline: injected into rectus sheath \& locally	Ultra- Sound Rectus Sheath Block Group n=25 Participants bupivicaine will be injected in the rectus sheath Bupivacaine Hydrochloride: ultra sound guided injection into the rectus sheath
Postoperative Pain at 6 Hours After Procedure.	5.16 score on a scale Standard Deviation 2.304	5.28 score on a scale Standard Deviation 2.011	2.64 score on a scale Standard Deviation 1.497

SECONDARY outcome

Timeframe: Measurement of serum cortisol level (nmol/ liter) using the ELISA technique after 1 hour of the start of the surgery.

Population: Measurement of serum cortisol level (nmol/ liter) using the ELISA technique after 1 hour of the start of the surgery.

Measurement of serum cortisol level (nmol/ liter) using the ELISA technique after 1 hour of the start of the surgery.

Outcome measures

Outcome measures
Measure	Local Group n=25 Participants bupivicaine will be injected locally Bupivacaine Hydrochloride: injected locally	Control Group n=25 Participants normal saline will be injected in the rectus sheath Normal saline: injected into rectus sheath \& locally	Ultra- Sound Rectus Sheath Block Group n=25 Participants bupivicaine will be injected in the rectus sheath Bupivacaine Hydrochloride: ultra sound guided injection into the rectus sheath
Change in the Level of Serum Cortisol.	286.92 nmol/ liter Standard Deviation 225.404	307.84 nmol/ liter Standard Deviation 220.569	214.00 nmol/ liter Standard Deviation 148.198

SECONDARY outcome

Timeframe: 1 hour after the start of the surgery using ELISA technique.

Population: Measurement of serum adrenaline levels (ng/ml) 1 hour after the start of the surgery using ELISA technique.

Measurement of serum adrenaline levels (ng/ml) 1 hour after the start of the surgery using ELISA technique.

Outcome measures

Outcome measures
Measure	Local Group n=25 Participants bupivicaine will be injected locally Bupivacaine Hydrochloride: injected locally	Control Group n=25 Participants normal saline will be injected in the rectus sheath Normal saline: injected into rectus sheath \& locally	Ultra- Sound Rectus Sheath Block Group n=25 Participants bupivicaine will be injected in the rectus sheath Bupivacaine Hydrochloride: ultra sound guided injection into the rectus sheath
Measurement of Serum Adrenaline Levels (ng/ml) Using ELISA Technique.	2.704 ng/ml Standard Deviation 1.1264	2.508 ng/ml Standard Deviation 1.2530	2.556 ng/ml Standard Deviation 1.4030

SECONDARY outcome

Timeframe: 1 hour after the start of the surgery

Population: Measurement of serum noradrenaline levels (ng/ml) 1 hour after the start of the surgery using ELISA technique.

Measurement of serum noradrenaline levels (ng/ml) 1 hour after the start of the surgery using ELISA technique.

Outcome measures

Outcome measures
Measure	Local Group n=25 Participants bupivicaine will be injected locally Bupivacaine Hydrochloride: injected locally	Control Group n=25 Participants normal saline will be injected in the rectus sheath Normal saline: injected into rectus sheath \& locally	Ultra- Sound Rectus Sheath Block Group n=25 Participants bupivicaine will be injected in the rectus sheath Bupivacaine Hydrochloride: ultra sound guided injection into the rectus sheath
Measurement of Serum Noradrenaline Levels (ng/ml) Using ELISA Technique.	15.920 ng/ml Standard Deviation 7.3389	12.088 ng/ml Standard Deviation 4.6656	17.380 ng/ml Standard Deviation 9.0959

SECONDARY outcome

Timeframe: 30 minutes before the start of the surgery

Population: Measurement of serum cortisol level (nmol/ liter) using ELISA technique 30 minutes before the start of the surgery

Measurement of serum cortisol level (nmol/ liter) using ELISA technique 30 minutes before the start of the surgery

Outcome measures

Outcome measures
Measure	Local Group n=25 Participants bupivicaine will be injected locally Bupivacaine Hydrochloride: injected locally	Control Group n=25 Participants normal saline will be injected in the rectus sheath Normal saline: injected into rectus sheath \& locally	Ultra- Sound Rectus Sheath Block Group n=25 Participants bupivicaine will be injected in the rectus sheath Bupivacaine Hydrochloride: ultra sound guided injection into the rectus sheath
Measurement of Serum Cortisol Level (Nmol/ Liter) Using ELISA Technique.	170.52 nmol/ liter Standard Deviation 91.421	159.02 nmol/ liter Standard Deviation 119.455	327.05 nmol/ liter Standard Deviation 215.569

SECONDARY outcome

Timeframe: 30 minutes before the start of the surgery

Population: Measurement of serum adrenaline level (ng/ml) using ELISA technique 30 minutes before the start of the surgery.

Measurement of serum adrenaline level (ng/ml) using ELISA technique 30 minutes before the start of the surgery.

Outcome measures

Outcome measures
Measure	Local Group n=25 Participants bupivicaine will be injected locally Bupivacaine Hydrochloride: injected locally	Control Group n=25 Participants normal saline will be injected in the rectus sheath Normal saline: injected into rectus sheath \& locally	Ultra- Sound Rectus Sheath Block Group n=25 Participants bupivicaine will be injected in the rectus sheath Bupivacaine Hydrochloride: ultra sound guided injection into the rectus sheath
Measurement of Serum Adrenaline Level (ng/ml) Using ELISA Technique.	2.00 ng/ml Standard Deviation 1.416	1.42 ng/ml Standard Deviation 0.774	3.96 ng/ml Standard Deviation 2.262

SECONDARY outcome

Timeframe: 30 minutes before the start of the surgery.

Population: Measurement of serum noradreline levels (ng/ml) using ELISA technique 30 minutes before the start of the surgery.

Measurement of serum noradrenaline levels (ng/ml) using ELISA technique 30 minutes before the start of the surgery.

Outcome measures

Outcome measures
Measure	Local Group n=25 Participants bupivicaine will be injected locally Bupivacaine Hydrochloride: injected locally	Control Group n=25 Participants normal saline will be injected in the rectus sheath Normal saline: injected into rectus sheath \& locally	Ultra- Sound Rectus Sheath Block Group n=25 Participants bupivicaine will be injected in the rectus sheath Bupivacaine Hydrochloride: ultra sound guided injection into the rectus sheath
Measurement of Serum Noradrenaline Levels (ng/ml) Using ELISA Technique.	12.932 ng/ml Standard Deviation 6.4223	9.960 ng/ml Standard Deviation 4.2880	20.880 ng/ml Standard Deviation 10.5235

Adverse Events

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ultra- Sound Rectus Sheath Block Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Local Infilteration Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Muhammed Hussein

Theodor Bilharz Research Institute

Phone: 00201001434459

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place